MSRC Latest MS News

CogniFit coaches MS patients to improve memory & cognition

Fri, 19 Mar 2010 03:50:00 EST

CogniFit�, Inc., a leading maker of Brain Fitness Software, announced a new, independent study that shows CogniFit Personal Coach brain training software improves the cognitive function and skills of Multiple Sclerosis (MS) patients. Many people with MS suffer some cognitive impairment as a result of disease. Patients who trained with the program showed significant improvement in 10 fundamental cognitive skills. Results of this study are published in the current issue of NeuroRehabilitation. During this study, one group of MS patients used CogniFit Personal Coach software for 20-30 minutes, three times a week for 12 weeks, and a control group did not participate in any training. For those individuals who used CogniFit Personal Coach, memory skills showed the greatest improvement. The training group exhibited a general memory increase of 21%, a visual working memory increase of 20% and a verbal-auditory working memory increase of 20% over and beyond that of the control group. Post-hoc, finer-grained analyses of the data showed that linguistic short-term and working memory had improved by 14% and 16% respectively in the cognitive training group over and beyond improvements in the control group. The post-hoc analyses also revealed that participants in the cognitive training group were exhibiting significant improvements, over those in the control group, in naming speed (9%), speed of object recall (10%), focused attention (8%), visuo-motor attention (10%) and visual spatial working memory (8%). The study also examined the unprompted and voluntary adherence rate of MS patients to cognitive training and results show that despite fatigue, a common characteristic side-effect of MS, the majority of the patients (71%) adhered to the training program. Patients who did not adhere were younger than patients who adhered, and in those patients severity of the disease was lower. MS is a chronic inflammatory disease that causes lesions in the nervous system. As part of the nervous system, the brain often sustains some of this damage, leading to cognitive impairment. Although attention/concentration and processing speed, as well as executive functions such as verbal fluency, concept formation, abstract reasoning, planning and monitoring are commonly affected by MS, memory is one of the areas that is most compromised. Researchers believe that CogniFit Personal Coach's ability to target the areas that need training most led to the dramatic improvements seen particularly across the different types of memory. "While patients in the cognitive training group were significantly improving vital cognitive functions using an enjoyable cognitive intervention at home, in the control group cognitive growth was often non-existent," said Dr. Evelyn Shatil, article author and Head of Cognitive Science at CogniFit. "We also observed high real-life adherence rates for patients with neurological disorders who trained - unprompted and voluntarily - in the privacy of their homes. Together, the findings offer great hope for comprehensive home-based personalized medicine which combines cognitive training interventions with medication therapy." CogniFit Personal Coach provides scientifically validated cognitive training that is tailored to meet the specific needs of individuals. Following a baseline assessment, users engage in exercises designed to train their brain which continually adjust to the level of the user. As a result, people using CogniFit software are challenged enough to improve their abilities, but not frustrated by the software's difficulty level. As users' skills improve, the training also evolves. Previous studies using the CogniFit Personal Coach software have shown its ability to improve cognitive skills in elderly people with satisfactory and lower cognitive function. Source: Medical News Today � 2010 MediLexicon International Ltd (19/03/10)

7 more cases of a PML & one death in MS patients using Tysabri

Thu, 18 Mar 2010 08:37:00 EST

Biogen Idec Inc. disclosed seven more cases of a rare brain infection in multiple sclerosis patients using Tysabri, which it sells with Elan Corp, bringing the total number of cases to 42 as of last Wednesday. Another patient with the infection has died, bringing the total deaths to nine in patients that have developed progressive multifocal leukoencephalopathy, or PML, according to the Cambridge, Mass., biotech company. Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped because of concerns about the risk of PML, concerns that led to its 18-month market withdrawal beginning in 2005. Of the total number of cases, 15 were in the U.S., 24 were in the European Union and three were in other areas. Biogen gave its last update in mid-February. In January, the Food and Drug administration provided a safety update that noted an increased risk of getting PML as the number of infusions of the medicine increase. The agency concluded that the benefits of the medicine continue to outweigh the risks. The number of cases is important because if the infection rate climbs too high, sales of the drug may drop. Tysabri's withdrawal from the market occurred after three patients developed PML. The infection re-emerged in mid-2008, and Biogen provided regular updates about the cases until mid-2009. The company began providing monthly updates last month. Source: Nasdaq Copywrite The Nasdaq Stock Market, Inc.(18/03/10)

Sativex For MS Regulatory Update

Thu, 18 Mar 2010 06:10:00 EST

Sativex Regulatory Update - UK and Spanish regulators confirm no major issues outstanding. Regulatory process now at advanced stage. Approvals expected Q2 2010. GW Pharmaceuticals plc today provided an update on the progress of its regulatory submission for Sativex� Oromucosal Spray for the treatment of the symptoms of spasticity due to Multiple Sclerosis. The regulatory submission was filed in the UK and Spain under the European decentralised procedure in May 2009, with the UK acting as the Reference Member State. The regulatory process has now reached �Day 150� of the decentralised procedure and both the UK and Spanish regulators have concluded that there are no major quality, safety or efficacy issues remaining to be resolved. Resolution is now required only of points of clarification related to finalisation of wording on the patient information leaflet. We expect this document to be reviewed by the regulators in the coming weeks. Once the regulators have agreed final wording on the patient leaflet, the decentralised procedure can close and the process will enter its final phase. This final phase, known as the national phase, takes place separately in the UK and Spain and its purpose is to finalise local wording on product packaging and related documents. GW therefore expects regulatory approval in the UK and Spain during Q2 2010. Dr Stephen Wright, GW�s R&D Director, said, �This is a major milestone in the regulatory process for Sativex, and for GW�s future prospects. We look forward to working with the regulators towards a successful completion of this process and to supporting our marketing partners as they prepare for product launch. This progress with Sativex also provides further validation of GW�s cannabinoid platform and the significant long term promise of GW�s portfolio of cannabinoid medicines.� Sativex will be marketed in the UK by Bayer Schering Pharma, and in the rest of the European Union by Almirall S.A. Upon UK regulatory approval, GW expects to receive a �10m milestone payment from Bayer. A further �2.5m milestone payment is payable by Almirall following both regulatory and pricing approval in Spain. Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure. Source: GW Pharamceuticals (18/03/10)

Ibudilast in relapsing-remitting multiple sclerosis. A neuroprotectant?

Wed, 17 Mar 2010 10:29:00 EST

BACKGROUND: Ibudilast is a phosphodiesterase inhibitor influencing inflammation and neurodegeneration in multiple sclerosis (MS). This study evaluated the safety, tolerability, and effects on MRI parameters of 2 different doses of ibudilast in relapsing forms of MS. METHODS: In this multicenter, double-blind, phase 2 trial, patients with relapsing MS and gadolinium-enhancing lesions were randomly assigned 1:1:1 to receive 30 or 60 mg ibudilast or placebo every day for 12 months. The primary endpoint was the cumulative number of newly active lesions on bimonthly brain MRI over 12 months. Secondary endpoints included relapse rate, change in Expanded Disability Status Scale (EDSS) score, T2-hyperintense and T1-hypointense lesion volumes, and percent brain volume change (PBVC). RESULTS: A total of 297 patients were randomized in 19 centers. During the first 12 months, the mean number of active lesions and relapse rate did not differ between treatment arms. A reduction in PBVC (p = 0.04) was found in the 60-mg group (0.8%) compared with placebo (1.2%). Post hoc analysis showed a reduction in the proportion active lesions that evolved into persistent black holes for the 60-mg (0.14; p = 0.004) and 30-mg (0.17; p = 0.036) groups compared with the placebo group (0.24). Over 2 years, there were fewer patients (p = 0.026) with confirmed progression on the EDSS. Treatment with ibudilast was generally safe and well tolerated. CONCLUSION: Ibudilast showed no beneficial effect on the rate of newly active lesions and relapses. However, preliminary evidence suggests that ibudilast seems to act in a neuroprotective fashion as measured by 2 independent MRI outcomes, with a possible beneficial clinical effect on disability progression. Classification of evidence: This interventional study provides Class III evidence on the effect of ibudilast on disease activity. Barkhof F, Hulst HE, Drulovic J, Uitdehaag BM, Matsuda K, Landin R; For the MN166-001 Investigators. From the Image Analysis Center (F.B., H.E.H.) and MS Centre (B.M.J.U.), VU University Medical Center, Amsterdam, The Netherlands; Kliniki Centar Srbije (J.D.), Institut za Neurologiju Beograd, Serbia; and Medicinova Inc. (K.M., R.L.), San Diego, CA. Source: Pubmed PMID: 20200338 (17/03/10)

Absence of Epstein-Barr virus in the brain and CSF of patients with multiple sclerosis

Wed, 17 Mar 2010 05:14:00 EST

OBJECTIVE: Epstein-Barr virus (EBV) is a ubiquitous human herpesvirus that becomes latent in B-lymphocytes and has been implicated in the pathogenesis of multiple sclerosis (MS). We searched for latent and active EBV infection in MS brain and CSF. METHODS: Nested and non-nested real-time PCR were used to detect cell-specific and EBV-specific transcripts in 15 fresh-frozen and 5 formalin-fixed paraffin-embedded MS plaques and in single MS CSF B-lymphocytes and plasma cells. Intrathecal anti-EBV antibody synthesis was measured by ELISA. Immunocytochemistry was used to detect binding of MS CSF and recombinant antibodies (rAbs) generated from clonally expanded plasma cells in MS CSF to EBV-infected cells. RESULTS: No EBV RNA was found in MS CSF B-lymphocytes or plasma cells. In active MS plaques, EBV-encoded RNA (EBER)-1 was the only and rarely detected transcript. The frequency of detected intrathecal anti-EBV antibody synthesis in patients with MS did not differ from that in non-MS inflammatory CNS disease control patients. Anti-EBV antibodies were detected in the CSF of patients with MS, but MS rAbs did not react with EBV. CONCLUSIONS: Application of real-time PCR to multiple sclerosis brain and single B-lymphocytes in CSF did not reveal any evidence of active Epstein-Barr virus infection. Sargsyan SA, Shearer AJ, Ritchie AM, Burgoon MP, Anderson S, Hemmer B, Stadelmann C, Gattenl�hner S, Owens GP, Gilden D, Bennett JL. From the Departments of Neurology (S.A.S., A.J.S., A.M.R., M.P.B., S.A., G.P.O., D.G., J.L.B.), Microbiology (D.G.), and Ophthalmology (J.L.B.), University of Colorado Denver School of Medicine, Aurora; Department of Neurology (B.H.), Technische Universit�t, Munich; Universit�tsmedizin der Georg-August-Universit�t G�ttingen (C.S.), G�ttingen; and Department of Pathology (S.G.), Julius-Maximilians-University, W�rzburg, Germany. Source: Pubmed PMID: 20220124 (17/03/10)

Antiviral immune response in patients with multiple sclerosis and healthy siblings

Tue, 16 Mar 2010 10:18:00 EST

Summary The cause of MS is yet to be found. However, both environmental and genetic factors are believed to contribute to its pathogenesis. Amongst the environmental factors, viruses seem to play an important role. The authors of this article suggest that the nature of the immune response to Epstein-Barr virus is associated with the risk of developing MS. Mult Scler. 2010 Mar;16(3):355-8 Details The objective of this study was to determine the immune responses to candidate viral triggers of multiple sclerosis in patients and healthy siblings raised in the same family household. Virus antigen-specific IgG responses to Epstein-Barr virus-derived gene products as well as to human herpersvirus-6, human cytomegalovirus, and measles virus were evaluated in 25 multiple sclerosis patients and compared with 49 healthy full-siblings. IgG responses to the latent Epstein-Barr virus-encoded nuclear antigen-1 (EBNA1) were selectively increased in individuals with multiple sclerosis compared with their unaffected siblings. We conclude that elevated IgG responses towards EBNA1 are associated with the development of multiple sclerosis. Source: MS Society of Canada (16/03/10)

Advanced multiple sclerosis and the psychosocial impact on families

Mon, 15 Mar 2010 12:32:00 EST

This study explores family relationships and support needs when adapting to a relative's advanced-multiple sclerosis (MS) around transition into care. A multi-site qualitative study of relatives of people with advanced-MS was conducted. A purposive sample of 25 relatives was selected and interviewed either in the care home or participants' homes. Interviews were recorded, transcribed and analysed using grounded theory methodology and Atlas.ti 5.2 software. Data quality enhancement involved: a self-report questionnaire; triangulation and member-checking. Themes derived from the data were: information, communication and understanding; family relationships, roles and responsibilities; emotions, coping and support; life outlook and reflection. Provision of information and support for families around the transition into care appears to be inconsistent despite there being a need for family members to ask questions and discuss the impact of the condition. Relatives reported that as a family and as individuals they faced significant challenges and were in great need of support at times, but reflected that they would have found it very difficult to accept. Relatives were also often unsure what type of support would have helped. For care providers, there needs to be a shift from the traditional health care professional 'patient-centred' mindset towards more proactive family-centred approaches and steps to encourage this are articulated. Bowen C, Maclehose A, Beaumont JG. The Institute for Neuropalliative Rehabilitation, Royal Hospital for Neuro-disability, London SW15 3SW, UK. Source: Pubmed PMID: 20204981 (15/03/10)

Advanced MRI may speed diagnosis of multiple sclerosis

Mon, 15 Mar 2010 05:43:00 EST

MRI has become central to the diagnosis of multiple sclerosis, a complex disease of the central nervous system that affects over 400,000 people in Europe. Around 90% of all MS diagnoses are now based on MRI findings, owing to the modality�s high sensitivity to inflammation and demyelinating plaques. Trials have shown that an early diagnosis can make a big difference to the efficacy of MS drug treatments. Familiarity with the optimum diagnostic strategy is consequently crucial. Work is also under way to identify imaging biomarkers that could show whether a selected treatment is working, well before that same conclusion can be drawn from clinical findings. Members of the European Magnetic Imaging in Multiple Sclerosis (MAGNIMS) network shared with ECR delegates their expertise on MS diagnosis and management. The state-of-the-art session included practical tips for general radiologists who are faced with a potential case of MS, as well as details about research that will appeal to specialists in neuroradiology. �From a practical point of view, the most important message is to be familiar with the diagnostic criteria,� said Dr. Alex Rovira, head of the MRI unit at the Vall d�Hebron University Hospital, Barcelona, Spain, and the session chair. �In most European countries, the criteria required to start treatment for MS is to establish the diagnosis, and this is done with MRI. To avoid a wrong diagnosis, we have to know about the typical features of this disease and how we should apply imaging criteria.� An imaging-led diagnosis of MS is typically based on conventional MRI techniques. T2-weighted imaging can reveal lesions that indicate the presence of inflammation, demyelination, gliosis, axonal loss, and even remyelination. This information may be used by radiologists to estimate the overall burden of MS disease. Contrast-enhanced T1-weighted MRI can also be used to detect lesions that are currently active. A firm diagnosis is not usually made until the disease has been identified clinically in a separate part of the central nervous system some time after the initial onset of symptoms. It may take a couple of years for this criterion to be met. Repeated MRI, on the other hand, may identify new �silent� lesions and speed up the diagnosis. Alternatively, and of equal importance, imaging may be able to exclude MS and identify another cause of the patient�s symptoms. Once the diagnosis has been made, the value of MRI to MS patients begins to waver. Radiologists would like to use MRI to track progression of the disease, and perhaps even forecast periods of remission and relapse, but it is difficult to predict the outcome of treatment based on conventional MRI findings alone. What you see on imaging does not necessarily reflect what benefit the patient will get. The main reason for this clinical-radiological paradox is the complexity of MS. A number of factors contribute to disease severity, and not all of this information can be captured from T2- and T1-weighted imaging alone. Conventional MRI techniques may be able to spot MS lesions, but they say little about changes occurring within those lesions or about damage to brain tissue that has a �normal� appearance. More sophisticated techniques, such as MR spectroscopy (MRS), diffusion tensor imaging (DTI), and functional MRI (fMRI) are needed to complete the picture. �MS is not just focal inflammatory demyelination, as we used to think. There are a lot of additional things going on,� said Prof. Massimo Filippi, director of the Neuroimaging Research Unit at San Raffaele University in Milan, and one of the session�s three invited speakers. �It is a more complex puzzle that we still need to define.� This process would be aided if the application of these nonconventional MRI techniques could be standardized, according to Filippi. Clear criteria for the diagnosis of MS based on conventional MRI approaches have already been established, but as yet, there is no common language covering MRS, DTI, and/or fMRI findings. Nonconventional MRI techniques are becoming increasingly important in preclinical and clinical trials as companies move forward in developing neuroprotective drugs, as well as anti-inflammatory agents. The development of internationally acceptable guidelines relating to MRI-based monitoring of MS would help researchers from different institutions to compare their results. �We are lucky to have MRI, which is not a single technique but a set of techniques. We should not be using the same technique in all scenarios, but tailoring our approach to MRI when addressing different research questions,� Filippi said. Source: DiagnosticImaging.com � 1996 - 2010 UBM Medica LLC (15/03/10)

Gloucestershire Multiple Sclerosis sufferer calls for pioneering treatment

Mon, 15 Mar 2010 05:04:00 EST

Multiple sclerosis sufferer Stefan Cambridge is calling for a pioneering treatment to be available in the UK. As a child, the now 34-year-old spent years caring for his father who had MS before seeing him die. Just five years later he received the devastating news he too had the disease. Stefan, who uses a wheelchair and walking sticks, recently travelled to Poland for surgery which he says has halted the progression of the debilitating condition which affects all kinds of nerve function. He is now calling for the pioneering surgery to be made available on the NHS. The dad-of-one, who has a progressive form of the condition, said: "I lost my dad to MS at a young age and I know what this illness can do. "For someone like me not to progress is like a miracle. For people who have the procedure done early on before the damage starts then it's more of a cure." Stefan, whose father died from MS at the age of 42, paid �4,000 to have an angioplasty performed on his jugular vein to widen it. The surgery, which is not available on the NHS in the UK, follows initial studies abroad which suggest MS is linked to a narrowing in the veins which drain the spine and brain. It is not known if this condition, known as chronic cerebrospinal venous insufficiency (CCSVI), is a cause of MS but researchers are reported to have said it is at least an important association. Some patients who have had similar procedures have even reported an improvement in symptoms. Stefan, from Bishop's Cleeve, returned from Poland in January and believes the surgery he had has stopped his MS getting worse. The former Bournside School pupil found out about the studies on internet MS forums. Stefan and his sister Gillian cared for their father until his death in 2003. There is no cure for MS but it has not been shown to be hereditary in medical studies, so Stefan was shocked and devastated when he was diagnosed. "I just couldn't believe it when I got diagnosed. I have done everything I possibly can to try to get better," he said. Opinion is divided in the medical world about the treatment Stefan received. Researchers at Stanford University in America are reported to have halted treatments after one patient died from a brain haemorrhage following a procedure and another required emergency open heart surgery after a jugular vein stent dislodged. The MS Society says it is open to receiving grant applications to fund research into CCSVI within the UK. Dr Doug Brown, biomedical research manager at the society, said: "The MS Society has followed reports on CCSVI closely but we need to see more evidence before we can make any firm conclusions on whether CCSVI can cause MS or whether treating it would have any effect on MS. We would not advise people to seek unproven treatments outside of a properly controlled clinical trial." A Department of Health spokesperson said: "The NHS is constantly expanding the range and types of treatments available and we are always interested to know about new and innovative treatments that will not only provide benefits for the patients but for the NHS as well. "Surgery is not without risk and all new treatments must be examined for their effectiveness, safety and cost. We look forward to further research in this area." A group is trying to get this treatment set up in the UK. Visit http://www.ms-ccsvi-uk.org/ for details. Source: thisisgloucestershire.co.uk Copywrite Gloucestershire Media Ltd. (15/03/10)

Dr Dake's CCSVI Presentation To The SIR 25th Annual Scientific Meeting

Mon, 15 Mar 2010 04:23:00 EST

Dr Dake's CCSVI Presentation To The SIR 25th Annual Scientific Meeting

BNAC CCSVI Update 12/03/10

Sun, 14 Mar 2010 03:34:00 EST

BNAC CCSVI UPDATE - http://www.bnac.net/?page_id=561

MS Society of Canada - CCSVI Web Streaming Event

Fri, 12 Mar 2010 06:46:00 EST

MS Society Of Canada - CCSVI Web Streaming Event - http://www.mssociety.ca/en/research/ccsviWebcast.htm Date: Wednesday, April 7, 2010 Time: 1:00pm - 3:00pm ET Date: Wednesday, April 7, 2010 Time: 1:00pm - 3:00pm ET (6pm - 8pm GMT) Source: MSRC General CCSVI News - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=2954

Standardized cannabis in Multiple Sclerosis: A case report

Fri, 12 Mar 2010 04:05:00 EST

Abstract A 52 year old female suffering from severe progressive multiple sclerosis was administered quantifiable amounts of standardized cannabis and monitored over the period of one year, while providing daily pain charts and records of her condition. An average daily intake of 500 mg of Tetrahydrocannabinol as cannabis was required to achieve a desired quality of life. Introduction Multiple Sclerosis (MS) is a difficult disease both to diagnose and to treat. Diagnosis often requires multiple visits to the physician and it may take years before MS is diagnosed, typed and treated. There is no cure for MS. Treatment is based on powerful immune system suppressants, mainly steroids and various types of Interferon, although others may be used as well. In addition, many types of medications including anticholinergics, antispasmodics, benzodiazepines and opiates are used to manage the muscle spasms, bladder incontinence issues and nerve pain that may be associated with MS. They do however prevent recurrence and slow progression of the illness. Prevention of MS through vitamin D supplementation is an intriguing possibility. In the study described here we trace the cannabis use of an MS patient over the course of one year. High Pressure Liquid Chromatography (HPLC) was performed to quantify cannabis. The subject made significant improvement with better pain control, decreased muscle spasms and general quality of life. The case described here is one of many observed at the Green Cross Society of B.C. Case Presentation The subject in this study, a 52-year-old female, is a member of the Green Cross Society which is a non-profit, organization, dedicated to supplying quality controlled, standardized cannabis to its qualified members. The participant involved in this year-long study was chosen primarily because she had an attentive, full-time, caregiver, who had tracked her illness since its beginning in the late 1970's. It was the caregiver that first noticed that cannabis was beneficial in relieving her symptoms. This however, was sometime after the disease was diagnosed. Initially she was subjected to a 10-day regimen of ACTH, plus various muscle relaxants and anxiolytics. Intermittent ACTH treatment occurred until 1985 when Magnetic Resonance Imaging confirmed her diagnosis with MS. She then began daily injections of Copaxone, which gave benefits including reduction of muscle spasms and a degree of pain management. In addition, she would also smoke cannabis to further alleviate symptoms. Initial symptoms had included numbness of the right side of the lip, and a depressed gag reflex that made swallowing difficult. These symptoms had been present for a decade prior to the suspicion and diagnosis of MS. In 1983, she began experiencing extreme pain in her lower lumbar region that radiated to her left foot, affecting her ability to walk. When she first came to the Society in 2007, she complained of chronic pain, tremor, difficulty in walking and a severe constant pain in her left foot. Through the Green Cross Society, the subject received advice on the best cannabis strain selection for her symptoms plus options on means of administration and dosage regimens. For the following year she ingested cannabis that had been tested for concentrations of the most abundant cannabinoids including Delta-9 Tetrahydrocannabinol (THC), Cannabidiol (CBD) and Cannabinol (CBN). Her caregiver provided daily (email) pain charts, plus ingested medications, and a description of the subject's general well being throughout the study. Discussion Results were assessed through daily dialogue with the subject's caregiver, review of accumulated pain charts, plus the subject's testimony. An almost immediate improvement was seen in the patient's condition when she began administering the standardized oral preparations. Pain scores were reduced from an 8�10 to 1�2 over the period of the first month during which time the optimal dosing regimen was established. Greatest benefit for pain and tremor was achieved consuming 6�8, 50 mg capsules per day, dosing at 4-hour intervals. The subject also consumed an average of 4�6 cannabis cigarettes per day, for breakthrough pain and/or mood enhancement. Measurement of the mean THC concentration of these cigarettes was 172 � 26 n = 30, that would equate to a dosage of 25 mg of THC per cigarette (0.5 grams per cigarette with roughly 70% loss to atmosphere),[1] adding another 125 mg to her daily consumption, totaling between 400 and 500 mg per day of THC. The average relative amounts of CBD and CBN are roughly 3% of that found for THC. A significant improvement in pain levels, tremor and general well being were observed. Functionally, the patient went from a state of virtual incapacitation to one where she can dress, go for walks and do some gardening: a dramatic improvement over the course of one year. The presence of CBD and CBN, although claiming no psychoactive effect, appear to modulate the binding of THC to its receptor and thus alter the efficacy of the preparation. The relative ratio of these three cannabinoids is determined by the specific strain of cannabis. Over the course of the study year it was found that the subject experienced optimal relief with strains containing relatively high CBD to THC ratio of 4�6%, a high THC concentration and relatively low CBN amount. Observations made with the study subject and, indeed, verified day-to-day at the Society is that those managing chronic pain prefer these ratios. The seemingly high amounts of THC (approximately 500 mg/day) required by the subject to manage her symptoms are often observed with persons of her genealogy (Scottish). An earlier publication on the effects of standardized cannabis and chronic pain management describes a similar tolerant response.[2] A phenomenon often witnessed at the Society is persons with Celtic genealogy require 3�5 five times greater dosage than those of Middle European or other descent. The only observed unwanted side effects were seen when the strain used in the oral capsules was changed to one that did not provide the same pain or anti-tremor relief as the strain provided at an earlier time. Simply put, there was some discomfort experienced in changing strains. Since the subject was receiving the medication by mail, from time to time, she would run out of the oral preparation at which time her symptoms would worsen to their pre-regimen state within days. Recent tests of liver functions proved normal. Conclusions The established non-toxicity of cannabis and non-addictive properties[3] make it an excellent candidate for treating the symptoms of numerous illnesses. The case described here is one of many observed at the Green Cross Society of B.C. Abbreviations CBD-A: Cannabidiolic acid; CBD: Cannabidiol; CBN-A: Cannabinolic Acid; CBN: Cannabinol; THC-A: Tetrahydrocannabinolic Acid; THC: Delta-9 tetrahydrocannabinol; THF: tetrahydrofuran; HPLC: high performance liquid chromatography. Consent Written informed consent was obtained from the patient for publication of this case report. A copy of the written consent is available for review by the Editor-in-Chief of this journal. Competing interests The authors declare that they have no competing interests. Authors' contributions PH conducted data collection and analysis, plus manuscript draft preparation. MS, interpreted data and edited the manuscript. Acknowledgements The authors would like to thank the membership of the Green Cross Society for their unwavering support and help through all the studies conducted last year. Cases J. 2010;3:7 � 2010 Cases Network, Ltd. Source: Medscape from WebMD � 1994-2010 by WebMD LLC. (12/03/10)

Peptimmune announces second grant of a United States patent for PI-2301 peptide copolymer for Multiple Sclerosis

Wed, 10 Mar 2010 03:57:00 EST

Peptimmune, Inc. a privately held biotechnology company, announced the grant of US Patent Number 7,655,221 (the '221 patent) which protects the target product profile for its PI-2301 peptide copolymer for the treatment of multiple sclerosis, and other autoimmune diseases. The '221 patent claims important treatment modalities for PI-2301 and related compounds. "The '221 patent enhances the exclusivity for what we believe may become a very important therapy for the treatment of multiple sclerosis and other autoimmune diseases," stated Thomas P. Mathers, President & CEO of Peptimmune. Peptimmune recently completed a Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study in subjects with SP-MS. The Company plans to continue developing PI-2301 by initiating a Phase II study in multiple sclerosis patients later this year. PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone� (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry. In preclinical studies, PI-2301 has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301. Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide. MS is an autoimmune disease in which the individual's immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted. Peptimmune Presentation at the upcoming meeting of the American Society for Experimental NeuroTherapeutics Dr. Eric Zanelli, Vice President Research, will make a presentation entitled "Induction of an anti-inflammatory immune response toward toxic species of alpha-synuclein; Immunomodulatory therapy for Parkinson's Disease" in the Oral Pipeline Session on March 5, 2010 from 2:00 pm - 6:00 pm in the Haverford Suite of the Crystal Ballroom of the Hyatt Regency Bethesda, Bethesda Maryland. Dr. Zanelli will discuss the application of Peptimmune's DEEP technology to the development of a first-line disease modifying treatment for Parkinson's Disease. About DEEP DEEP is a peptide copolymer technology that anticipates antigenic diversity while preserving specificity for the epitope of interest. DEEP takes advantage of Peptimmune's know-how in the solid-phase manufacturing of complex peptide mixtures. The technology combines the epitope specificity of a fixed-sequence peptide with the randomness of a broadly immune-interactive copolymer. Source: Medical News Today � 2010 MediLexicon International Ltd (10/03/10)

MSRC comments on Stanford University reportedly halting CCSVI treatments after two serious adverse events

Mon, 08 Mar 2010 06:51:00 EST

Researchers at Stanford University have halted treatments for chronic cerebrospinal venous insufficiency (CCSVI) according February's edition of the journal Annals of Neurology. The decision came after two people experienced serious side effects following stenting of the jugular veins, a procedure thought to correct CCSVI. One patient died from a brain haemorrhage following the procedure in August and another required emergency open heart surgery in November after a jugular vein stent dislodged into the right ventricle of the heart. Dr Jeffrey Dunn, associate director of Stanford's MS centre, called on other neurologists to speak out about the potential "dangers" of the unproven procedure: "If I can do anything to protect MS patients from the potentially devastating effects of false hopes or the risks of invasive and unproven treatment, I am happy to do so". Helen Yates, Chief Executive of the Multiple Sclerosis Resource Centre (MSRC) said: �Whilst the case of the man who had to have open heart surgery to deal with a slipped stent is accurate, the case of the woman who had a haemorrhage is less so. The lady in question had a pre-existing condition that meant she was much more susceptible to haemorrhage, in fact it has been ascertained since her death that it was nothing to do with the procedure at all and was, in fact, an adverse drug reaction to one of the blood thinning drugs exacerbating a genetic familial problem. The first case is, of course, a reminder that no procedure is without risk and with stenting, there is always a slight risk of the stent coming loose. It is important that these two cases are viewed accurately and in perspective� The theory that CCSVI may play a role in causing MS was developed by Italian Cardiovascular Surgeon Dr Paolo Zamboni and has resulted in much debate and controversy. It has also sparked interest in many of the 2.5 million people with MS world-wide as a potential cause of MS. Dr John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society in the USA said, "When dealing with a disease like MS, where we don't know the cause or have many therapeutic options, it's important to think outside the box. Dr Zamboni is doing this, but his techniques need to be confirmed. He went on to add, "All of the evidence today is preliminary. There is not even enough evidence to say that obstruction of veins might be a factor in MS, or to determine when this obstruction may occur in the course of disease." MS Societies around the world have emphasised that new research studies will be pivotal in determining the link between CCSVI and MS before surgical procedures should be made available to treat CCSVI. Researchers in Buffalo NY are investigating the prevalence of CCSVI in people with MS. Dr Robert Zivadinov, Director of the Buffalo Neuroimmaging Analysis Centre and principle investigator of the Buffalo says: "If we can prove our hypothesis, that cerebrospinal venous insufficiency is the underlying cause of MS, it's going to change the face of how we understand MS", but he added that media coverage of CCSVI so far has been premature and "unrealistic". Source: MSRC &Medical News Today � 2010 MediLexicon International Ltd & MSRC (08/03/10)

Vitamin D 'triggers and arms' the immune system

Mon, 08 Mar 2010 04:36:00 EST

The so-called sunshine vitamin, which can be obtained from food or manufactured by human skin exposed to the sun, plays a key role in boosting the immune system, researchers believe. In particular it triggers and arms the body's T cells, the cells in the body that seek out and destroy any invading bacteria and viruses. Scientists at the University of Copenhagen have discovered that Vitamin D is crucial to activating our immune defences and that without sufficient intake of the vitamin, the killer cells of the immune system � T cells � will not be able to react to and fight off serious infections in the body. For T cells to detect and kill foreign pathogens such as clumps of bacteria or viruses, the cells must first be �triggered� into action and "transform" from inactive and harmless immune cells into killer cells that are primed to seek out and destroy all traces of invaders. The researchers found that the T cells rely on vitamin D in order activate and they would remain dormant, �na�ve� to the possibility of threat if vitamin D is lacking in the blood. Professor Carsten Geisler from the Department of International Health, Immunology and Microbiology, said: "When a T cell is exposed to a foreign pathogen, it extends a signalling device or �antenna� known as a vitamin D receptor, with which it searches for vitamin D. "This means that the T cell must have vitamin D or activation of the cell will cease. If the T cells cannot find enough vitamin D in the blood, they won�t even begin to mobilise. � The discovery, the scientists believe, provides much needed information about the immune system and will help them regulate the immune response. This is important not only in fighting disease but also in dealing with anti-immune reactions of the body and the rejection of transplanted organs. Active T cells multiply at an explosive rate and can create an inflammatory environment with serious consequences for the body. After organ transplants, T cells can attack the donor organ as a �foreign invader�. In autoimmune diseases, like arthritis or Crohns Disease, T cells mistake fragments of the body�s own cells for foreign invaders, leading to the body launching an attack upon itself. For the research team, identifying the role of vitamin D in the activation of T cells has been a major breakthrough. �Scientists have known for a long time that vitamin D is important for calcium absorption and the vitamin has also been implicated in diseases such as cancer and multiple sclerosis, but what we didn�t realise is how crucial vitamin D is for actually activating the immune system � which we know now, � said the researchers. The findings, continues Professor Geisler, �could help us to contain infectious diseases and global epidemics. They will be of particular use when developing new vaccines, which work precisely on the basis of both training our immune systems to react and suppressing the body�s natural defences in situations where this is important � as is the case with organ transplants and autoimmune disease.� Most Vitamin D is produced as a natural by-product of the skin�s exposure to sunlight. It can also be found in fish liver oil, eggs and fatty fish such as salmon, herring and mackerel or taken as a dietary supplement. The findings are published in the latest edition of Nature Immunology. Source: Telegraph.co.uk � Copyright of Telegraph Media Group Limited 2010 (08/03/10)

Stars are all coming out for Tiger

Fri, 05 Mar 2010 09:58:00 EST

Glasgow�s top stars are to appear on stage at a special benefit night for one of the city�s best-loved entertainers. Pop stars such as Marti Pellow, Midge Ure and Hue and Cry will appear on the bill at the Pavilion theatre in Tribute To Tiger Tim. All proceeds will go to a special benefit fund to send veteran DJ Tim Stevens, who is battling multiple sclerosis, to Poland for radical new treatment. Also on the bill will be Tony Roper and Gerard Kelly, who will appear as Francie and Josie, and Tam Cowan. The glittering event, on Saturday, May 15, promises to be one of the best variety shows in the theatre�s history. Pavilion boss Iain Gordon said: �There are few people as popular in Glasgow as Tim Stevens. �When I heard that Tim was having to raise �9,000 to pay for his treatment I figured it shouldn�t be down to him to pay this sort of money out of his own pocket, so I offered up the theatre for a special show. �It really makes so much sense. Tim once starred here in panto, and as a radio presenter and charity worker he�s given so much to the city. �It�s fantastic that our top performers are prepared to recognise that. And I�m sure the public will want to enjoy the night and show their appreciation for all that Tim has done for them.� Tim and his wife Caroline will attend the event, being organised by Wet Wet Wet drummer Tommy Cunningham. Ex-Radio Clyde DJ Paul Coia will host the event and several other top Clyde DJs will make an appearance. Tommy said: �Tim Stevens is a man of the people. He�s been a great broadcaster and communicator but, more importantly, he�s a great bloke. �When I left the band, Tim was one of the first people to call and offer support.� The evening will also feature filmed messages of support for Tim and show his career highlights. The finale will feature all the performers on stage for a rendition of the Beatles classic, With A Little Help From My Friends. Tiger Tim�s MS was first diagnosed in the late 1980s and his condition has steadily deteriorated and he now uses a wheelchair. However, in recent months new hope for MS sufferers has emerged with a surgical procedure called �the liberation procedure�. Tim�s wife Caroline said: �I heard about this CCSVI treatment from family in Canada and since then we�ve been tracking down more information from Italy, America and Poland before deciding to go ahead. From what we�ve discovered, the results achieved in Poland seem to be incredible.� The surgery is based on the theory that MS is caused by narrowed veins. However, there are no guarantees that it will cure Tim. But Tim, 58, who has tried almost every possible �cure� for MS over the years, is optimistic. He said: �I hope to have some degree of success. But what I want most is to be able to offer some degree of hope to the other 80,000 MS sufferers in Scotland.� Tickets for Tribute To Tiger Tim, priced �25, will go on sale at the Pavilion on Monday. Source: Evening Times � 2010 Herald & Times Group (05/03/10)

Researchers find further evidence linking Epstein-Barr virus and risk of multiple sclerosis

Fri, 05 Mar 2010 02:51:00 EST

Researchers from the Harvard School of Public Health, Walter Reed Army Institute of Research, and a team of collaborators have observed for the first time that the risk of multiple sclerosis (MS) increases by many folds following infection with the Epstein-Barr virus (EBV). This finding implicates EBV as a contributory cause to multiple sclerosis. The study appears in an advance online edition of the journal Annals of Neurology and will appear in a later print edition. Hundred of thousands of individuals not infected with EBV were followed up for several years through repeated blood samples collections. Researchers were then able to determine the time when individuals developed an EBV infection and its relation to MS onset. "The recruitment of individuals before they were infected with EBV and following up with them for several years is the critical methodological aspect that makes this study qualitatively different from all previous work," said Alberto Ascherio, senior author of the study and professor of epidemiology and nutrition at Harvard School of Public Health and professor of medicine at Harvard Medical School. MS is a chronic degenerative disease of the central nervous system. Women are more likely than men to get the disease and it is the most common neurologically disabling disease in young adults. Although genetic predisposition plays an important role in determining susceptibility, past studies have shown that environmental factors are equally important. EBV is a herpes virus and one of the most common human viruses worldwide. Infection in early childhood is common and usually asymptomatic. Late age at infection, however, often causes infectious mononucleosis. In the U.S., upwards of 95% of adults are infected with the virus, but free of symptoms. EBV has been associated with some types of cancer and can cause serious complications when the immune system is suppressed, for example, in transplant recipients. There is no effective treatment for EBV. This is the first study based on the longitudinal follow-up of several thousand individuals who were not infected with EBV at the time of recruitment. The study population was made up of active-duty US Army, Navy, and Marines personnel who have at least one blood sample in the Department of Defense Serum Repository. The electronic databases of the Physical Disability Agencies of the US Army and Navy were then searched for individuals whose records indicated a possible diagnosis of MS reported between 1992 and 2004. The researchers selected 305 individuals diagnosed with MS and who had blood specimens collected before the date of their diagnosis. Two controls for each case were then selected from the serum database and matched by branch of service, sex, date of blood collection, and age at time of blood collection. The study found that MS risk is extremely low among individuals not infected with EBV, but it increases sharply in the same individuals following EBV infection. "The observation that MS occurred only after EBV is a big step forward," said Alberto Ascherio. "Until now we knew that virtually all MS patients are infected with EBV, but we could not exclude two non-causal explanations for this finding: that EBV infection is a consequence rather than a cause of MS, and that individuals who are EBV negative could be genetically resistant to MS. Both of these explanations are inconsistent with the present findings," said Ascherio. "The evidence is now sufficiently compelling to justify the allocation of more resources to the development of interventions targeting EBV infection, or the immune response to EBV infection, as these may contribute to MS prevention," he said. The study was supported by a grant from the National Institute of Neurological Disorders and Stroke. "Primary Infection with the Epstein-Barr Virus and Risk of Multiple Sclerosis," Lynn I. Levin, Kassandra L. Munger, Eilis J. O'Reilly, Kerstin I. Falk, Alberto Ascherio, Annals of Neurology, online January 20, 2010 Source: ScienceBlog Copyright, Science Blog 2010. (05/03/10)

Multiple Sclerosis sufferer shows improvement after CCSVI treatment in Poland

Wed, 03 Mar 2010 11:29:00 EST

A mother from Seaford said her MS sufferer daughter has shown initial improvements after travelling to Poland for tests. Michele Findlay made the trip with her 30-year-old daughter Ella and Ella's boyfriend last month. Since returning to the UK the Kedale Road resident said Ella, who was diagnosed with multiple sclerosis 10 years ago, has seen some positive changes. Mrs Findlay said her daughter did not feel much in the way of improvement in the first four to five days but added, "Her feet are warmer and that is one of the problems she had for a long time with the inability to keep her feet warm. When we got home she seemed to be more energetic and she says she is walking better and walking longer distances than she had been in the last nine, 10 months. "People are noticing that she is more alert and more energetic." Mrs Findlay travelled abroad to find out if her daughter had Chronic Cerebrospinal Venous Insufficiency (CCSVI). This follows a preliminary study by a leading surgeon called Dr Paolo Zamboni from Italy who used ultrasound and magnetic resonance venography to examine the blood vessels leading in and out of the brain of hundreds of patients. He found that the majority of all his patients with multiple sclerosis he treated had defective circulation in their neck - a defect he has called CCSVI. Mrs Findlay said tests on Ella showed that she did have CCSVI. She added, "I'm pleased that we had the most experienced doctor in this to look at her because if it hadn't been for his experience at treating patients we may well have come home without any treatment at all because it wasn't very obvious at first sight where the problem was. "They found it in the right jugular vein between the jaw and ear." After tests confirmed CCSVI the Farnham resident then had what is called liberation treatment which in her case involved being injected with an opaque dye and then a deflated balloon is guided up to the point of constriction and once there is inflated to widen the vein. The procedure is designed to help free the blood flow. Mrs Findlay said, "There is a worry that the vein will collapse and that could happen tomorrow, in six months or a year but if it remains opens for as long as a year then they would do another treatment using the balloon. Hopefully things will improve some more, if the only thing that happens is she doesn't get worse that's good as well." Mrs Findlay has, with another UK resident Gary Barclay, helped to set up a website about CCSVI. For more information visit: http://www.ms-ccsvi-uk.org/ Source: Eastbourne Herald �2010 Johnston Press Digital Publishing (03/03/10)

UBC researchers planning to study MS vein theory

Wed, 03 Mar 2010 03:24:00 EST

A medical centre in British Columbia says it wants to become the first in the country to test the controversial theory that multiple sclerosis patients have blocked veins, preventing proper blood flow from the brain. "There's a large demand for us to look into this," Dr. Anthony Traboulsee told CTV News. "Patients are very excited. We are very interested ourselves, and we want to meet the demand of our patients." A group of researchers at the University of British Columbia MS Clinic, part of the Vancouver Coastal Health Authority, are planning to study the theory, using a variety of imaging techniques. If it gets approval and funding, it appears to be the most comprehensive examination of this novel theory in the world. They will be studying the findings of Italian researcher Dr. Paolo Zamboni, who believes that blocked veins in the neck and chest of MS patients lead to blood drainage problems and triggers the immune responses that mark the disease. Zamboni contends that angioplasty surgery on these blocked veins, a procedure he calls the Liberation Treatment, can then open them. A preliminary study of the treatment in 65 patients showed it improved the quality of life for many patients, and as long as the veins remained open, symptoms of MS were reduced and new attacks were halted. The BC team envisions a study that begins with MS patients being scanned for abnormalities, likely using the ultrasound test pioneered in Italy. They would also be given MRI scans, to see how the different tests detect possible problems. The prevalence of vein problems would also be assessed in MS patients and in normal healthy control patients. Data would also be blinded to minimize the risk for bias in the research. Once these non-invasive scans have been done, test patients would proceed to the angiography suite. There they would undergo a venogram. That's where a probe is inserted, from the groin, into the vein system that travels through the chest and into the neck. Doctors inject a dye and watch the blood-flow. This is also, according the University of Ferrara team, the definitive way of seeing blockages in the jugular veins in the neck and the azygos vein in the chest. And if there are blocked or narrowed veins, the UBC researchers want to open them up to see what happens. "Not only do we want to see if we can detect these abnormalities, we also want to see, if we change them, does it improve peoples' lives?" said Traboulsee. The B.C. researchers, who include radiologists, vascular specialists, and physicists working on new imaging technologies, say they had heard about the theory before CTV's W5 aired a story describing the theory, and were investigating the possibility of a study. But interest in the theory in Canada has exploded since the episode aired. A professor of neurosurgery at the University of Buffalo, Dr. Robert Zivadinov, who worked on an early study with Zamboni, says his office was contacted by 8,000 MS patients in the three weeks after the W5 episode aired. The Vancouver researchers want to determine the prevalence of the vein abnormality, which Zamboni has dubbed CCSVI -- or chronic cerebrospinal venous insufficiency. They also want to know how easily it can be detected with ultrasound and MRI testing. Joining the study will be Alex Rauscher, a physicist. He hopes to look at MRI scans of patients to search for evidence of iron deposits in the brain, since some research has suggested that iron in the brain may contribute to the inflammation and the immune system attacks that mark MS. "It is our duty to find the answers," said Rauscher. The Vancouver Coastal Health researchers say they have applied for funding from the MS Society of Canada to fund research to determine the most practical and reliable test for CCSVI. But because of the size and scope of the study -- and their desire to begin quickly -- they are also accepting funding from other agencies and private donations. Donations should be directed to: VGH and UBC Hospital Foundation - UBC Faculty of Medicine (funds can be specified for CCSVI research) The researchers note that their study is not accepting patients yet and likely won't for a few months until they acquire funding, obtain ethical approval, and develop an MRI and ultrasound testing protocol. Patients are asked to refrain from contacting the clinics until they are ready to proceed with the study. Meanwhile in Italy, one of the companies that manufactures the ultrasound machines used in the testing for CCSVI, is beginning to hold training sessions for doctors and technicians who want to learn the novel technique for scanning the neck and head. One training program is being held this week at the University of Ferrara with technicians who developed the tests, and with Zamboni. A second session is planned for March. Contact information for the course is available through: Claudio.Buffagni@esaote.com Source: CTV News � 2010 CTVGlobeMedia (03/03/10)

Atorvastatin Combined To Interferon to Verify the Efficacy (ACTIVE) in relapsing-remitting active multiple sclerosis patients: a longitudinal controlled trial of combination therapy

Tue, 02 Mar 2010 03:08:00 EST

Summary Interferon beta (IFNb) is a first-line treatment for people with MS, but its efficacy may vary amongst different people. Statins are known to have anti-inflammatory properties. In this unicentre controlled clinical trial carried out with 45 participants, the authors aimed to assess safety, tolerability and efficacy of low-dose atorvastatin, which belongs to the group of statins, plus subcutaneous IFNb-1a (Rebif44�), given for 24 months, in people with MS responding poorly to interferon beta-1a. The people that received the combined therapy (atorvastatin plus IFNb-1a) had better outcome than those that received IFNb-1a alone, in terms of active inflammatory lesions in the MRI, relapses, and risk of increasing disability. The authors have concluded that low-dose atorvastatin may be beneficial, as add-on therapy, in poor responders to high-dose interferon beta-1a alone. Details A large body of evidence suggests that, besides their cholesterol-lowering effect, statins exert anti-inflammatory action. Consequently, statins may have therapeutic potential in immune-mediated disorders such as multiple sclerosis. The objectives were to determine safety, tolerability and efficacy of low-dose atorvastatin plus high-dose interferon beta-1a in multiple sclerosis patients responding poorly to interferon beta-1a alone. Relapsing-Remitting multiple sclerosis patients, aged 18-50 years, with contrast-enhanced lesions or relapses while on therapy with interferon beta-1a 44 microg (three times weekly) for 12 months, were randomized to combination therapy (interferon + atorvastatin 20 mg per day; group A) or interferon alone (group B) for 24 months. Patients underwent blood analysis and clinical assessment with the Expanded Disability Status Scale every 3 months, and brain gadolinium-enhanced magnetic resonance imaging at screening, and 12 and 24 months thereafter. Primary outcome measure was contrast-enhanced lesion number. Secondary outcome measures were number of relapses, EDSS variation and safety laboratory data. Forty-five patients were randomized to group A (n = 21) or B (n = 24). At 24 months, group A had significantly fewer contrast-enhanced lesions versus baseline (p = 0.007) and significantly fewer relapses versus the two pre-randomization years (p < 0.001). At survival analysis, the risk for a 1-point EDSS increase was slightly higher in group B than in group A (p = 0.053). Low-dose atorvastatin may be beneficial, as add-on therapy, in poor responders to high-dose interferon beta-1a alone. Source: MS Society Of Canada (02/03/10)

Blood brain barrier compromise with endothelial inflammation may lead to autoimmune loss of myelin during multiple sclerosis

Mon, 01 Mar 2010 05:21:00 EST

Multiple sclerosis is an autoimmune disease characterized by multifocal areas of inflammation and demyelination within the central nervous system. The mechanism that triggers the disease remains elusive. However, recent findings may indicate that multiple sclerosis, at its source, could be a hemodynamic disorder. It has been found that multiple sclerosis patients exhibit significant stenoses in extracranial veins draining the central nervous system (in azygous and internal jugular veins), which are associated with significant pressure gradients measured across strictures. Such anatomic venous abnormalities were not found in the control group of healthy subjects. In this review, it is hypothesized that pathological refluxing venous flow in the cerebral and spinal veins increases the expression of adhesion molecules, particularly intercellular adhesion molecule-1 (ICAM-1), by the cerebrovascular endothelium. This, in turn, could lead to the increased permeability of the blood-brain barrier. Inflamed and activated endothelium could secrete proinflammatory cytokines, including GM-CSF and TGF-beta In these settings, monocytes could transform into antigen-presenting cells and initiate an autoimmune attack against myelin-containing cells. Consequently, a potential therapeutic option for multiple sclerosis could be pharmacotherapy with either substances that strengthen the tight-junctions barrier, or with agents that reduce the expression of adhesion molecules. In addition, surgical correction could be an option in some anatomical variants of pathologic venous outflow. We are optimistic that a hemodynamic approach to the multiple sclerosis pathogenesis can open a new chapter of investigations and treatment of this debilitating neurologic disease. Simka M. Department of Angiology, Private Healthcare Institution SANA, Pszczyna, Poland. Source: PMID: 19442163 (01/03/10)

Iron leads to memory impairment that is associated with a decrease in acetylcholinesterase pathways

Mon, 01 Mar 2010 04:22:00 EST

Perez VP, de Lima MN, da Silva RS, Dornelles AS, Vedana G, Bogo MR, Bonan CD, Schr�der N. Neurobiology and Developmental Biology Laboratory, Faculty of Biosciences, Pontifical Catholic University, Av. Ipiranga, 6681 Pr�dio 12C, Sala 340, 90619-900 Porto Alegre, RS, Brazil. Increasing evidence indicates that excessive iron in selective regions of the brain may be involved in the etiology of neurodegenerative disorders. Accordingly, increased levels of iron have been described in brain regions of patients in Parkinson's and Alzheimer's diseases. We have characterized neonatal iron loading in rodents as a novel experimental model that mimics the brain iron accumulation observed in patients with neurodegenerative diseases and produces severe cognitive impairment in the adulthood. In the present study we have investigated the involvement of the cholinergic system on iron-induced memory impairment. The effects of a single administration of the acetylcholinesterase (AChE) inhibitor galantamine or the muscarinic receptor agonist oxotremorine on iron-induced memory deficits in rats were examined. Male Wistar rats received vehicle or iron (10.0 mg/kg) orally at postnatal days 12 to 14. At the age of 2-3 months, animals were trained in a novel object recognition task. Iron-treated rats showed long-term impairments in recognition memory. The impairing effect was reversed by systemic administration of galantamine (1 mg/kg) immediately after training. In addition, iron-treated rats that received oxotremorine (0.5 mg/kg) showed enhanced memory retention. Rats given iron showed a decreased AChE activity in the striatum when compared to controls. The results suggest that, at least in part, iron-induced cognitive deficits are related to a dysfunction of cholinergic neural transmission in the brain. These findings might have implications for the development of novel therapeutic strategies aimed at ameliorating cognitive decline associated with neurodegenerative disorders. Source: Pubmed PMID: 20158466 (01/03/10)

The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics

Sun, 28 Feb 2010 04:10:00 EST

Chronic cerebrospinal venous insufficiency(CCSVI) is a vascular picture that shows a strong association with multiple sclerosis (MS). The aim of this study was to investigate the relationship between a Doppler cerebral venous hemodynamic insufficiency severity score (VHISS) and cerebrospinal fluid (CSF) flow dynamics in 16 patients presenting with CCSVI and relapsing-remitting MS (CCSVI-MS) and in eight healthy controls (HCs). The two groups (patients and controls) were evaluated using validated echo-Doppler and advanced 3T-MRI CSF flow measures. Compared with the HCs, the CCSVI-MS patients showed a significantly lower net CSF flow (p=0.027) which was highly associated with the VHISS (r=0.8280, r2=0.6855; p=0.0001). This study demonstrates that venous outflow disturbances in the form of CCSVI significantly impact on CSF pathophysiology in patients with MS. Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R. Source: Pubmed PMID: 20018140 (28/02/10)

Specialist nurse role 'critical to care'

Sat, 27 Feb 2010 03:23:00 EST

The Royal College of Nursing (RCN) is calling for every patient with a long-term condition to have access to specialist nursing care. It wants guaranteed funding to avoid cutbacks in specialist nurses after the general election. It says specialist nurses save money through reduced complications and fewer hospital re-admissions. Prime Minister Gordon Brown recently announced that cancer patients would have access to specialist nurses. Specialist nurses focus on particular conditions such as cancer, Parkinson's, multiple sclerosis and epilepsy. The RCN says they can deliver savings by enabling patients to be treated at home rather than in hospital and help people manage their condition with less support from their GP. It calculates that specialist nurses caring for people with Parkinson's, multiple sclerosis and epilepsy could deliver savings of �220m a year. The RCN surveyed nearly 300 specialist nurses and 60 health organisations. It found that more than a third of respondents had seen posts cut over the last year and over half fear future cuts. The nurses' union says it has "significant concerns" that posts could be lost as funding dries up. It says this happened in 2006 when many specialist roles were cut, frozen or downgraded because of hospital deficits. In addition to guaranteed NHS funding to prevent cutbacks, it wants the funding of specialist nursing posts which are paid for by voluntary organisations to be underwritten by the NHS. 'Lifeline' Dr Peter Carter, RCN chief executive and general secretary, said: "While the temptation may be to cut or downgrade specialist nursing roles, this would be a false economy which would only add to the growing cost of treating long-term conditions. "Specialist nurses are a unique lifeline for patients and families, who are unequivocal in saying that the specialist nurse is the key factor in preserving their quality of life." Earlier this month, the prime minister announced plans to provide dedicated one-to-one care by specialist nurses for everyone with cancer. The Department of Health in England said �20 million has been set aside for the first 12 months of the five-year programme. Opposition parties praised the contribution of specialist nurses but questioned how the plan would be delivered. Conservative health spokeswoman Anne Milton said: "Specialist nurses have been a fantastic development over the last few decades bringing better outcomes, better quality and saving money. "It is time to appreciate what a contribution they can make when money is tight." Norman Lamb, Liberal Democrat health spokesman, said: "There is a real danger that the NHS will respond to the financial crisis by taking a slash and burn approach to its essential staff and services that make a real difference to patients with chronic conditions. "This is a false economy and will be devastating for patient care." Source: BBC News � British Broadcasting Corporation 2010 (27/02/10)

Italian researchers discover a possible onset mechanism for Multiple Sclerosis

Fri, 26 Feb 2010 05:30:00 EST

A non-pathogenic bacterium is capable to trigger an autoimmune disease similar to the multiple sclerosis in the mouse, the model animal which helps to explain how human diseases work. This is what a group of researchers from the Catholic University of Rome, led by Francesco Ria (Institute of General Pathology) and Giovanni Delogu (Institute of Microbiology), have explained for the first time in a recently published article on the Journal of Immunology. Multiple sclerosis is a disease due to an inflammatory reaction provoked by the immune system. It causes the disruption of the coating of the nerve fibres in the Central Nervous System. "We do not know what causes multiple sclerosis", explains Francesco Ria, immunologist of the Catholic University. "We know that there exist a genetic factor and an environmental factor, but we do not yet posses a satisfactory theory which can explain how exactly this environmental factor works". Currently, there are two competing theories on the field: according to a first hypothesis, a virus hides within the brain and what causes the disease is the immunologic antiviral reaction. On the other hand, the second hypothesis states that a viral or bacterial pathogen similar to specific molecules of the Central Nervous System causes an inflammation which provokes a reaction of the immune system. This reaction ends up destroying the brain cells. The latter is called the autoimmune hypothesis. This is the hypothesis that the researchers coming from the Institutes of General Pathology, Microbiology and Anatomy of the Catholic University of Rome have been testing with their two-year long work. To demonstrate the viability of this idea, scientists have fooled the mouse immune system, modifying subtly a bacterium of the common family of mycobacteria (the same family to which also the bacterium causing tuberculosis belongs) to make it look like to myelin, the protein coating nerve cells. This modified mycobacterium is completely innocuous. As all external agents, though, it is capable to trigger the reaction of the T-cells of the immune systems. They intervene to destroy it. Since they are innocuous bacteria, although very common in the environment, and since they induce an immune reaction, they are the ideal bacteria scientists can use to study the environmental factor contributing, together with the genetic factor, to cause multiple sclerosis. "Normally, T-cells cannot penetrate into the Central Nervous System", adds Rea, "because the hematoencephalic barrier prevents them from doing so. But the bacterium modifies the characteristics of the T-cells and allows them to overcome the barrier. In 15 days the bacterium disappears completely from the body". Yet these T-cells can now enter into the brain. This way, they begin to attack the myelin of the nerve cells, and here is how the immune disease breaks out. "We basically demonstrate � explains Rea � that in an animal model it is possible to be infected with something not carrying any disease, and later on develop a purely autoimmune disease". Yet there is another element in this complex research, sponsored by the Italian Association of Multiple Sclerosis (AISM). "Normally � clarifies Rea � to understand which diseases we have encountered, we measure the antibodies produced by that specific pathogen. But there is a whole world of infectious agents which do not induce the production of antibodies, as is the case in our research: mycobacteria and many other bacteria produce a very low and variable number of antibodies. It is thus very hard to establish whether a population has encountered that specific infectious agent. So, we demonstrate that those infectious agents which are more likely to produce an autoimmune reaction are just those which do not induce antibody production". Obviously, this is only the first step to better understand the way this very complex and devastating disease works. Ria and Delogu are not stopping here: "We want to try to understand the exact characteristics which this infectious agent should have", they explain. "Might it truly be a good experimental model for multiple sclerosis? If we had prolonged the action of the bacteria, would we have favoured or hampered the development of the disease? And what about the myelin-like bacterium protein: where should it lie? On the surface, or inside? These are all questions � conclude the two researchers � which we will be trying to answer in the next years, in the hope to defeat this terrible illness. We could even imagine to develop a vaccine by which we could prevent the immune response associated to multiple sclerosis". Source Eureka Alert! (26/02/10)

Copaxone(R) 15-year study in Multiple Sclerosis patients demonstrates robust long-term efficacy and safety

Thu, 25 Feb 2010 10:34:00 EST

Teva Pharmaceutical Industries Ltd. announced the publication of data from the 15-year clinical study with Copaxone(R) (glatiramer acetate injection), which is the longest prospective and continuous evaluation ever conducted in relapsing-remitting multiple sclerosis (RRMS) patients. The data were published in the February issue of the journal Multiple Sclerosis. The 15-year clinical study demonstrated that more than 80 percent of patients were still walking without assistance despite a mean MS disease duration of 22 years, and two-thirds of patients have not transitioned to secondary progressive MS. Patients who remained in the study over a mean of 15 years showed a reduction in annualized relapse rate (ARR) from baseline as well as minimal increase in Expanded Disability Status Scale (EDSS). On average, the ARR in the ongoing cohort declined from 1.12 � 0.82 to 0.25 � 0.34 at the 15-year analysis. Additionally, the study reinforces the established long-term safety profile associated with Copaxone(R). The most common adverse events associated with Copaxone(R) were local injection-site reactions and immediate post-injection reactions. No other immune-mediated disorders, infections or malignancies were reported. "This study is important for the MS community as it further confirms the benefits of continuous long-term use of Copaxone(R) and its ability to effectively slow the natural progression of this disease," said Corey Ford, M.D., Ph.D., primary investigator in the study and Professor of Neurology, Director of the Multiple Sclerosis Specialty Clinic and Assistant Dean for Research at the University of New Mexico Health Sciences Center. "It is encouraging to see such long-term results that further support the well-established benefit-to-risk profile of this treatment relevant to a life-long disease." "We are pleased to see that results from this study reinforce the long term efficacy and safety of Copaxone(R)," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "The longest term study extension further demonstrates Teva's investment in Copaxone(R) and our ongoing commitment to improve the disease course of MS." This study represents the only prospective, open-label follow-up study designed to evaluate continuous immunomodulatory therapy in RRMS patients. The study, currently in its 19th year, was extended to 20 years based on the positive results seen thus far and the interest of the MS community in the long term outcomes of treatments for this life-long disease. About the Study The study "Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15-Year Analysis of the U.S. Prospective Open-label Study of Glatiramer Acetate," a follow-up to the pivotal, Phase III trial, followed 100 ongoing Copaxone(R) (glatiramer acetate injection) patients starting in 1991. Patients' EDSS scores were evaluated every six months. Confirmed disability progression was defined as greater-than or equal to 1.0 EDSS point increase sustained for six months. Patients were classified as "stable/improved" if EDSS score changes were less or equal to 0.5 points. Proportions of patients who reached confirmed thresholds of EDSS 4, 6, or 8 while on Copaxone(R), and Kaplan-Meier (KM) estimates of median times to these thresholds, were obtained. Fifty-seven percent of patients experienced either stabilized or improved EDSS scores, while 65 percent has not yet transitioned to Secondary-Progressive Multiple Sclerosis (SPMS). While being treated with Copaxone(R), the mITT patients' ARR declined from 1.18+/-0.82 to 0.43+/-0.58/year. Source: Teva Pharmaceutical Industries Ltd. (25/02/10)

Assisted suicide - legal guidance due

Thu, 25 Feb 2010 05:06:00 EST

Full guidance aimed at clarifying what factors might mitigate against someone being prosecuted for helping another person to die is due to be released. A Law Lords ruling on an MS patient who wanted clarification on the possible prosecution of her husband forced the Director of Public Prosecutions to act. The guidance for England and Wales is not a law change on assisting suicide, which can carry a 14-year jail term. But campaigners against euthanasia fear vulnerable people could be put at risk. 'Important distinctions' Writing in the Times, Director of Public Prosecutions Keir Starmer said it was important to clarify what factors would be considered when considering whether or not to prosecute cases. He wrote: "In the light of recent discussion about so-called mercy killing, it is important to be clear about what the policy does not cover. It does not cover murder or manslaughter. "Assisted suicide involves assisting the victim to take his or her own life. Someone who takes the life of another undertakes a very different act and may well be liable to a charge of murder or manslaughter. "That distinction is an important one that we all need to understand." He said each case would be considered on an individual basis and prosecutors would "have to make professional judgements about difficult and sensitive issues". "The assisted suicide policy will help them in that task." More than 100 Britons with terminal or incurable illnesses have gone to the Swiss centre Dignitas to die and, to date, none of the relatives or friends involved in the cases has been prosecuted. This is because the authorities have the power to use their discretion under the terms of the 1961 Suicide Act. But in July the House of Lords ruled that Debbie Purdy, a multiple sclerosis patient from Bradford, West Yorkshire, who is in her mid-40s, had the right to know under what circumstances her husband Omar Puente would be prosecuted if he helped her travel abroad to die. In September, Mr Starmer published draft advice which set out a range of factors that would be taken into account. He said he hoped his guidance would bring greater clarity to the issue, although he added all cases would still be investigated by the police. Among the factors mentioned in his draft guidance that would determine a prosecution were: �Whether a person stood to benefit financially from assisting a suicide or if they were acting out of compassion �If the individual wanting to die was deemed competent enough and had a "clear and settled" wish to make such a decision. Particular attention would be paid to issues such as the individual being under 18 or having a mental illness �Whether the person was persuaded or pressured into committing suicide or if it was their own decision The framework came into force immediately, even though they were only in draft form. Mr Starmer will now update the guidelines following a consultation which received more than 4,500 responses. 'Right balance' Ms Purdy welcomed the advice at the time, saying it would give people confidence when making difficult decisions. Sarah Wootton, chief executive of the Dignity in Dying campaign group, which has been supporting Ms Purdy, said: "We were pleased with the draft guidance. "It struck the right balance between helping someone who is acting compassionately, but making it clear that malicious, self-serving acts will not be tolerated." But she also said she still wanted to see a change in the law to make assisted suicide legal under certain circumstances so people could get upfront guarantees. However, critics have warned having such detailed guidance could make prosecutions less likely and put vulnerable people at risk. Richard Hawkes, chief executive of disability charity Scope, said: "We know that many disabled people are genuinely frightened about any changes which risk weakening the protection offered by existing law and which could effectively create legislation by the backdoor." But Mr Starmer told BBC Radio 4's Today programme this was not the case. "We were required to clarify the law and it's impossible to do that without setting out factors - that's what the court ordered us to do. "But every case will be fully investigated and each of these factors carefully considered." Similar guidelines are expected in Northern Ireland. Scotland does not have a law on assisted suicide. Source: BBC News � British Broadcasting Corporation 2010

Chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis - counter arguments

Thu, 25 Feb 2010 02:57:00 EST

Chronic cerebrospinal venous insufficiency and multiple sclerosis Omar Khan, MD 1 *, Massimo Filippi, MD 2, Mark S. Freedman, MD, FRCPC 3, Frederik Barkhof, MD, PhD 4, Paula Dore-Duffy, PhD 1, Hans Lassman, MD 5, Bruce Trapp, PhD 6, Amit Bar-Or, MD, FRCPC 7, Imad Zak, MD 8, Marilyn J. Siegel, MD, FACR 9, Robert Lisak, MD, FRCP 1 1Multiple Sclerosis Center, Department of Neurology, Wayne State University School of Medicine, Detroit 2Neuroimaging Research Unit, Scientific Institute and University Hospital San Raffaele, Milan 3Multiple Sclerosis Research Unit, The Ottawa Hospital General Campus, University of Ottawa, Ottawa 4Department of Radiology and Amsterdam MS Center; VU University Medical Center, Amsterdam 5Centre for Brain Research, Medical University of Vienna, Vienna 6Department of Neurosciences; Lerner Research Institute, Cleveland Clinic, Cleveland 7Montreal Neurological Institute, McGill University, Montreal 8Department of Radiology; Wayne State University School of Medicine, Detroit 9Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis *Correspondence to Omar Khan, Multiple Sclerosis Center & Image Analysis Laboratory, Department of Neurology, Wayne State University School of Medicine 4201 St Antoine, 8A-UHC, Detroit, Michigan 48323 Ph: (313) 745-4280; Fax: (313) 966-9271 Abstract A chronic state of impaired venous drainage from the central nervous system, termed as chronic cerebrospinal venous insufficiency (CCSVI), is claimed to be a pathologic phenomenon exclusively seen in multiple sclerosis (MS). This has invigorated the causal debate of MS and generated immense interest in the patient and scientific communities. A potential shift in the treatment paradigm of MS involving endovascular balloon angioplasty or venous stent placement has been proposed as well as conducted in small patient series. In some cases, it may have resulted in serious injury. In this Point of View, we discuss the recent investigations that led to the description of CCSVI as well as the conceptual and technical shortcomings that challenge the potential relationship of this phenomenon to MS. The need for conducting carefully designed and rigorously controlled studies to investigate CCVSI has been recognized by the scientific bodies engaged in MS research. Several scientific endeavors examining the presence of CCSVI in MS are being undertaken. At present, invasive and potentially dangerous endovascular procedures as a therapy for patients with MS should be discouraged until such studies have been completed, analyzed, and debated in the scientific arena. Annals Of Neurology � 1999-2010 John Wiley & Sons, Inc. -------------------------------------------------------------------------------- An Open Letter to the Authors of Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis (Khan et al, 2010, Annals of Neurology) Ashton Embry, Direct-MS Background: A week ago a �Point of View� article on Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis was made available online at the website of Annals of Neurology. It was written by 11 authors, with both neurologists and radiologists being represented. Notably 7 of 11 authors (including the first four, senior authors) disclosed significant financial interests with pharmaceutical companies which produce drugs for MS (see Appendix). In their opinion piece, the authors discussed Dr Zamboni�s published work on CCSVI and concluded it should be considered �preliminary�. To my knowledge no one has ever considered it to be otherwise. Most of the article consisted of points and arguments that suggest it is not reasonable to consider CCSVI to be the main cause of the MS disease process. Such a discussion has some value although I must point out few are claiming CCSVI is the main driver of MS. Dr Zamboni has been very clear on this and simply says CCSVI may be a significant contributor to MS onset and progression. Thus, in their Point of View, the authors essentially put up a straw man and then spend most of the article taking it apart. Overall, most of their arguments against CCSVI as the main cause of MS are readily dismissed once MS is seen as an autoimmune disease often exacerbated by the presence of CCSVI. The only truly offensive part of the article was the authors� attempt to rationalize their self-serving desire that no one with MS should be tested for CCSVI. They emphasized the very rare occurrence of a serious adverse event associated with endovascular treatment and totally neglected to discuss the risks of not being tested and treated for CCSVI. Such a one-sided rationalization which is nullified by a blatant conflict of interest of most of the authors cannot be taken seriously. Below is an open letter to the authors. Dear Dr Khan and fellow authors, I recently read your opinion piece on CCSVI which was made available online in Annals of Neurology (Khan et al, 2010) last week. I see it as part of �MS Wars: Part II � The Medical Empire Strikes Back�. Overall, I enjoyed reading your article because I always find it useful to read the arguments of those who hold a different opinion than me on an important subject. I was also pleased that you restrained yourselves and did not follow Mark Freedman�s infamous lead and call Dr Zamboni�s work �a hoax�. The only part of the article I found distasteful was your advice for persons with MS to not get tested for CCSVI for at least 5-10 years (while further research is being done). I discuss this point in detail later. For a more up to date and more objective opinion piece on MS and CCSVI, I direct you to my recent article �CCSVI and Multiple Sclerosis: Integrating New Data to Help Guide Actions� which can be downloaded at http://tinyurl.com/yf36ege. This article interprets the relationship between the CCSVI and MS in light of the recently available results from CCSVI-related studies at the universities of Buffalo and Georgetown. Given you must have known this critical information would be available in early 2010, I am surprised you rushed into print before such crucial data were available. This made your �Point of View� hopelessly outdated on the day it became available. I can only surmise you did not want any solid data from the Buffalo and Georgetown studies to cause problems for your critique. In my article I also address the question of whether persons with MS should get tested and treated for CCSVI as soon as possible or should wait 5-10 years until major clinical trials are completed and analyzed. A reasonable answer to this question depends on the major new data from the universities of Buffalo and Georgetown. Your analysis of this same question without the benefit of these crucial data is sadly premature and poorly supported. As I will discuss later, my advice on this key question is the opposite of yours and, unlike yours, mine is supported by the new data and is not hopelessly compromised by unacceptable and major conflicts of interest. To me, given the robust results of the University of Buffalo Phase 1 study and the findings of hundreds of endovascular procedures which have already been done to relieve CCSVI (almost all have found major blockages in the veins draining the brain), there can be little doubt that CCSVI is associated with MS. And, as I argue in my article, because the vascular malformations which constitute CCSVI are mainly congenital (Georgetown data), there can be little doubt that CCSVI is an important factor in the MS disease process in many cases (definitely not all cases). Of course, without this new data, you could not offer any worthwhile opinions on whether or not CCSVI is part of MS. Furthermore, any claim that the established, robust association of CCSVI and MS is purely coincidental cannot be taken seriously although I am sure such an implausible thought will be offered by some. In my article, I interpret MS as an autoimmune disease which, in many cases, is exacerbated by the co-occurrence of CCSVI (in 25% of the healthy population and perhaps up to 60% of persons with MS according to the University of Buffalo work). I find the �either it�s autoimmune or it�s CCSVI� polarity which dominates your article to be overly simplistic. An integration of the two phenomena is the most reasonable model because both have very strong evidence supporting their involvement in MS. Of course, the new data were required for such an integrated model to become obvious. Another key question which you could not evaluate without the new data is whether or not CCSVI contributes to MS progression. The University of Buffalo results nicely show that the higher the disability, the higher the chance that CCSVI is involved. The congenital origin of the vascular malformations dictates that such results mean that CCSVI is an adjuvant to the MS disease process. If one has MS and CCSVI they have a much higher chance of progressing to a higher disability level than a person with MS but no CCSVI. Given the potential adverse effects of CCSVI on the CNS vascular system, such an empiricallysupported association is certainly rational and plausible. The argument that this relationship is due to MS causing CCSVI, an argument you mentioned in your article, is ruled out by the data although once again I am sure such an illogical interpretation will continue to be put forth. Many of you have experience with EAE, the animal model for MS as an autoimmune disease. I suggest you try to see the relationship of CCSVI and MS as being similar to the addition of tetanus toxin (opens BBB) to the myelin/adjuvant mix which drives autoimmunity in EAE. Given the above, if one has MS, they would be wise to get tested for CCSVI and, if necessary, treated for it. This is based on the logical reasoning (precautionary principle) that the chance of harm associated with doing nothing (i.e. progressing more rapidly and farther if CCSVI is present) is substantially greater than the chance of harm associated with having endovascular surgery to relieve CCSVI (extremely rare, serious side effects). As Mark �It�s a Hoax� Freedman correctly and perhaps prophetically said, �Time is Brain� (Freedman, 2009). With this, and the apparent role of CCSVI as an accelerant of the MS disease process, in mind, persons with MS do not have the luxury to follow your self-serving, time table and wait 5-10 years for what you see as required research to be completed. Of course, most people with MS realize the obvious and are desperately seeking such testing and treatment. Who wouldn�t if they had MS and were progressing (the current drugs really don�t do much for most in the long run). Notably, most neurologists are unable to understand or empathize with such a logical decision to want to get CCSVI treated if present. The advice in your opinion piece of not to get treated for CCSVI for at least 5 -10 years from now is both irresponsible and dangerous. And this brings us to the topic of the serious lack of objectivity of such advice. One big problem with you saying not to get treated for CCSVI is that almost all of you are closely aligned with the pharmaceutical industry and thus have a major conflict of interest when you offer such advice. Should we heed the advice of scientists closely allied with the petroleum industry when it comes how to address the potential problems of global warming? Of course not! We do not heed it because they have a blatant conflict of interest so we just don�t know if they are pulling a fast one or not. One thing we know for sure, it is highly unlikely their advice will be objective. Like it or not, the long list of drug company associations for most of the authors (see appendix below) disqualifies your �Point of View� as being a credible source when it comes to advice on what to do about a non-drug treatment like CCSVI. I would stress, you can�t have it both ways. You can�t take money from drug companies and then turn around and offer advice on a treatment which potentially would harm the drug companies. Naturally your advice is going to be �Don�t use the non-drug treatment. Use only the drugs�. How can it be otherwise and that is why advice from those with obvious conflicts of interest is self-serving and worthless. It is too bad that most neurologists aren�t like George Ebers of Oxford University and rise above the temptation to take the easy money from the drug companies and thus escape a barefaced conflict of interest. In summary, your Point of View is completely out of date and your advice regarding CCSVI testing and treatment is totally compromised and of no value. It is also potentially very harmful for persons with MS. Five to ten years is a very long time to have to wait for testing and treatment of CCSVI and such a long time represents a huge amount of lost brain (Time is Brain). I can only suggest you try hard to take a patient-centred, evidence-based approach and do everything you can to make testing and treatment of CCSVI available as soon as possible. Sincerely, Dr Ashton Embry President, Direct-MS Appendix- Financial Disclosures of the Authors Dr Khan has received research support from the National MS Society (NMSS), the National Institutes of Health (NIH), Teva Neuroscience, Genzyme Corporation, Biogen Idec, Novartis Pharmaceuticals, and Acorda Therapeutics; consultancy and speaking honoraria from Teva Neuroscience, Biogen Idec, Novartis Pharmaceuticals, and Bayer Healthcare. Dr. Filippi has received research support from Bayer-Schering Pharma, Biogen- Domp� AG, Genmab A/S, Merck Serono, Teva Pharmaceutical Industries Ltd., Fondazione Italiana Sclerosi Multipla (FISM), and Fondazione Mariani; consultancy and speaking honoraria from Bayer Schering Pharma, Biogen-Domp� AG, Genmab A/S, Merck Serono, Teva Pharmaceutical Industries Ltd. Dr. Freedman has received research support from the Canadian MS Society, EMD Merck- Serono, Genzyme, and Bayer Schering Pharma; consultancy and speaking honoraria from Teva Neuroscience, Bayer Healthcare, and EMD Merck-Serono. Dr Barkhof has received research support from the Dutch MS Research Foundation and Merck- Serono; consultancy and speaking honoraria from EMD Merck-Serono, Bayer-Schering Pharma, Biogen-Idec, UBC, Sanofi-Aventis, Novo-Nordisk. Dr Dore-Duffy has received research support from the NMSS and the NIH. Dr Trapp has received research support from the NIH, NMSS, Canadian MS Society, Ohio Third Frontier, Vertex, and EMD Merck-Serono; consultancy and speaking honoraria from Teva Neuroscience, Biogen Idec and Pfizer. Dr. Bar-Or has received research support from the MS Society of Canada (MSSC) and the MSSC Research Foundation, The Canadian Institutes of Health Research, the FRSQ, Bayhill Therapeutics, Biogen Idec, Bio MS, Genentech, and Teva Neuroscience; consultancy and speaking honoraria from Biogen Idec, Eli Lilly, Genentech, MerckSerono, Novartis, Roche and Teva Neuroscience. Dr Lisak has received research support from the NMSS, NIH, Teva Neuroscience, and Questcor; consultancyand speaking honoraria from Teva Neuroscience and Bayer Healthcare. Drs Siegel, Lassmann, and Zak have nothing to disclose.

Early imaging predicts later cognitive impairment in primary progressive multiple sclerosis

Wed, 24 Feb 2010 06:23:00 EST

BACKGROUND: Cognitive impairment in primary progressive multiple sclerosis (PPMS) is common and correlates modestly with contemporary lesion burden and brain volume. Using a cohort/case control methodology, we explore the ability of MRI abnormalities, including those in the normal-appearing brain tissue, to predict future cognitive dysfunction in PPMS. METHODS: Thirty-one patients recruited into a longitudinal study within 5 years of onset of PPMS were assessed neuropsychologically on average 5.5 years later along with 31 matched healthy controls. MRI data obtained at entry into the study (lesion metrics, brain volumes, magnetization transfer ratio histogram metrics, and magnetic resonance spectroscopy metabolite concentrations) were used to predict cognitive impairment at follow-up. RESULTS: Twenty-nine percent of patients were categorized as cognitively impaired. T2 lesion volume was the best MRI predictor of overall cognitive function and performance on tests of verbal memory and attention/speed of information processing. Low gray matter magnetization transfer ratio was the best predictor of poor performance on a further test of attention/speed of information processing and an executive function test. Low gray and white matter volumes were independent predictors of poor performance on a second test of executive function. CONCLUSIONS: MRI abnormalities observed in early primary progressive multiple sclerosis can predict cognitive impairment 5 years later. While focal damage disrupting white matter tracts appears to be the most important predictor of subsequent cognitive dysfunction, gray matter pathology also plays a role. Penny S, Khaleeli Z, Cipolotti L, Thompson A, Ron M. Department of Neuroinflammation, UCL Institute of Neurology, Queen Square, London, WC1N 3BG, UK Source: Pubmed PMID: 20157157 (23/02/10)

Genome-wide association study in a high-risk isolate for Multiple Sclerosis reveals associated variants in STAT3 gene

Wed, 24 Feb 2010 04:26:00 EST

Genetic risk for multiple sclerosis (MS) is thought to involve both common and rare risk alleles. Recent GWAS and subsequent meta-analysis have established the critical role of the HLA locus and identified new common variants associated to MS. These variants have small odds ratios (ORs) and explain only a fraction of the genetic risk. To expose potentially rare, high-impact alleles, we conducted a GWAS of 68 distantly related cases and 136 controls from a high-risk internal isolate of Finland with increased prevalence and familial occurrence of MS. The top 27 loci with p < 10(-4) were tested in 711 cases and 1029 controls from Finland, and the top two findings were validated in 3859 cases and 9110 controls from more heterogeneous populations. SNP (rs744166) within the STAT3 gene was associated to MS (p = 2.75 x 10(-10), OR 0.87, confidence interval 0.83-0.91). The protective haplotype for MS in STAT3 is a risk allele for Crohn disease, implying that STAT3 represents a shared risk locus for at least two autoimmune diseases. This study also demonstrates the potential of special isolated populations in search for variants contributing to complex traits. Copyright � 2010 The American Society of Human Genetics. Published by Elsevier Inc. All rights reserved. Jakkula E, Lepp� V, Sulonen AM, Varilo T, Kallio S, Kemppinen A, Purcell S, Koivisto K, Tienari P, Sumelahti ML, Elovaara I, Pirttil� T, Reunanen M, Aromaa A, Oturai AB, S�ndergaard HB, Harbo HF, Mero IL, Gabriel SB, Mirel DB, Hauser SL, Kappos L, Polman C, De Jager PL, Hafler DA, Daly MJ, Palotie A, Saarela J, Peltonen L. Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki 00290, Finland; Unit of Public Health Genomics, National Institute for Health and Welfare, Helsinki 00271, Finland; Program in Medical and Population Genetics and Genetic Analysis Platform, The Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA. Source: Pubmed PMID: 20159113 (24/02/10)

Adeona announces completion of 50% enrollment in Trimesta(TM) Multiple Sclerosis clinical trial

Tue, 23 Feb 2010 09:28:00 EST

Adeona Pharmaceuticals, Inc. announced today that the clinical trial of its investigational drug Trimesta(TM) (estriol oral) being conducted by principal investigator Dr. Rhonda Voskuhl (Director, UCLA Multiple Sclerosis Program, UCLA Dept. of Neurology) has enrolled over 75 patients. The total planned enrollment is 150 patients. The Trimesta(TM) study is a double-blind, placebo-controlled clinical trial. Sixteen sites in the United States are currently enrolling patients. Investigators at these clinical sites are administering either Trimesta(TM) along with glatimer acetate (Copaxone(R)), an FDA approved therapy for multiple sclerosis, or a placebo plus glatimer acetate to women between the ages of 18 to 50 who have been recently diagnosed with relapsing-remitting multiple sclerosis. The primary endpoint is relapse rates at two years with a one year interim analysis using standard clinical measures of multiple sclerosis disability. Secondary endpoints of magnetic resonance imaging measurements of brain lesion and effects on cognition will also be studied. The Trimesta(TM) clinical trial has received a $5 million grant from the National Multiple Sclerosis Society in partnership with the National Multiple Sclerosis Society's Southern California chapter, with support from the National Institutes of Health. In January of 2010, it was announced that an additional $860,440 in grant funding had been received allowing the number of clinical sites enrolling patients for this study to more than double to 16 clinical sites. Trimesta(TM) has previously completed a 22-month, single-agent, crossover clinical trial in the United States for the treatment of relapsing remitting multiple sclerosis. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in multiple sclerosis) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with Trimesta(TM). "We are encouraged with the accelerated pace of patient enrollment in the Trimesta clinical trial," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "Based on the previous clinical trial results, we are hopeful that we will see an improvement in cognition in multiple sclerosis patients. Such a clinical finding would serve a compelling clinical need in these patients and highly differentiate the product from others currently in development." Source: Adeona Pharmaceuticals, Inc. (23/02/10)

Miracle MS 'cure' made me feel 'born again'

Tue, 23 Feb 2010 06:10:00 EST

Multiple sclerosis is a devastating disease which, until recently, had no possible cure. Martin Jones suffered with MS for 13 years. But following a groundbreaking operation on his veins, Martin is now enjoying using parts of his body he thought he had lost forever. Reporter HOLLY THOMPSON talks to him about his remarkable recovery. This time last year, Martin Jones could hardly leave the sofa. His body would spasm involuntarily, he couldn't walk, he couldn't sleep because his arms and legs twitched at random, and he would regularly choke on his food. "I was very close to being put in a nursing home and then probably dying," said Mr Jones. "I had lost my life. As far as I was concerned it was over. I couldn't do anything � just lie there on the sofa endlessly trying to sleep. I was basically paralysed." Now he can happily open the door to visitors, drive his car, and get up the stairs in one go. He is almost completely cured of a disease which doctors claim is incurable. And all it took was two operations on his veins under local anaesthetic. Mr Jones, 43, said: "I feel born again. "Life was pretty much over for me but now I'm trying to find time to fit in everything I want to do." The retired IT analyst was diagnosed with MS 13 years ago. He said: "I suddenly started to lose my balance and began accidentally treading on people's feet in the tube. "I went to the doctors for a scan, and it took them two years to diagnose MS. "They told me it was progressive and therefore incurable. It was a crushing blow but I tried not to let it get me down." Over the next few years Mr Jones's body began to deteriorate. He was forced to retire and spent his time lying on the sofa desperately scouring the internet for a cure. And last year, he struck gold. Mr Jones, of Sycamore Drive, Woodhatch, said: "I read about this syndrome called chronic cerebrospinal venous insufficiency(CCSVI) and how it can be cured with a simple operation. I was on the phone immediately to book myself in. "I had to travel to Poland to get it done but it was worth it. The moment it was over the first thing I realised was that I could feel my feet. I hadn't felt them for years. It was amazing." Mr Jones had his first operation in November last year, and the second in January. He now wants to use his newly-restored health to help others suffering from MS. He said: "The experience has made me evangelical. I want everyone to know about CCSVI and what it means. "Scientists in this country are dismissing the treatment and calling it a placebo, but I'm proof that it works and that there is hope for MS sufferers all over the world." Mr Jones and other MS sufferers are lobbying the Government to take this treatment seriously and perform it in the UK. To sign their petition, go to http://petitions.number10.gov.uk/CCSVINOW/ Source: thisissurrey.co.uk (c) East Surrey & Sussex News and Media Ltd (23/02/10)

Low Dose Naltrexone(LDN) improves mental health quality of life in MS

Mon, 22 Feb 2010 11:23:00 EST

A rapid on-line publication of the first randomised controlled trial of low dose naltrexone in MS in the Annals of Neurology has been reported prior to hard copy publication. The study randomised 80 people with MS to receive LDN or placebo in a cross-over study where people took the LDN or placebo for eight weeks, then swapped to the other study drug. This appears to be the first drug trial in MS that was not funded by the pharmaceutical industry, but by the participants themselves. The researchers found significant improvements for LDN over placebo in several mental health quality of life measures. This appears to be the beginning of formal research into LDN in MS, and further trials are eagerly awaited by the research community. Download the full accepted pre-publication version of the paper. Source: Taking Control of Multiple Sclerosis (22/02/10)

Clinical effect of neutralizing antibodies to interferon beta that persist long after cessation of therapy for Multiple Sclerosis

Mon, 22 Feb 2010 05:57:00 EST

OBJECTIVES: To confirm that neutralizing antibodies (NAb) to interferon beta can persist after therapy withdrawal and to evaluate whether persisting NAb are associated with a worse clinical disease course in multiple sclerosis (MS). DESIGN: Retrospective study. SETTING: Tertiary referral center in the Netherlands. Patients A total of 71 patients with relapsing-remitting multiple sclerosis treated with interferon beta in the past. MAIN OUTCOME MEASURES: Persisting NAb after therapy withdrawal were tested using the cytopathic effect assay. Patients with and without persisting NAb were compared on several outcomes: the change in annualized relapse rate from prior to interferon beta treatment initiation to after cessation of treatment, time to sustained disability on the Kurtzke Expanded Disability Status Scale, and the use of disease-modifying treatments after cessation of treatment with interferon beta. RESULTS: Seventeen of 71 patients (24%) tested NAb positive after a median interval of 25 months (interquartile range, 10-51 months) after interferon beta treatment cessation. Eleven of these 17 patients (15%) were high-titer NAb positive (>150 10-fold reduction units per mL). Persisting NAb were associated with an increase in the annualized relapse rate (P = .04) and a reduction in time to reach a sustained Expanded Disability Status Scale score of 6.0, ie, the need for unilateral assistance to walk 100 m (P = .02). Moreover, NAb-positive patients were treated with second-line therapy significantly more often, especially mitoxantrone (P = .006). CONCLUSION: Anti-interferon beta NAb can persist after interferon beta treatment withdrawal and are associated with overt clinical disease activity. This is made apparent by an increase in relapse rate and faster disability progression and is supported by the observed need for more aggressive therapy after interferon beta treatment cessation. Prospective studies are warranted to confirm these results. Source: Pubmed PMID: 20142519 (22/02/10)

Novartis' Gilenia (FTY720) gets FDA priority review status

Mon, 22 Feb 2010 04:06:00 EST

Novartis AG pulled further ahead of rival Merck in the bid to get the first oral multiple sclerosis treatment to market after the Swiss drugmaker's Gilenia was given U.S. priority review status. Novartis's Gilenia, FTY720, is competing with Merck MGaA's pill cladribine against the debilitating nervous disease. U.S. regulators held up Merck's application to bring its cladribine drug to market in November. The German drugmaker met with U.S. regulators in January about the approval process but it does not yet have a clear resubmission timetable. The priority review for Gilenia, which cuts the standard review time to six months from 10, comes after the U.S. Food and Drug Administration accepted the regulatory submission made in December for the drug. Novartis said, however, the FDA could still extend its review at the end of the six month period in June as Gilenia involves a new active ingredient, meaning the FDA is likely to require an advisory committee meeting. The two treatments from Novartis and Merck are expected to take a sizable chunk of the $8.6 billion market for MS since they are easier to take than the injectables from Teva, Biogen Idec, Bayer and Merck KGaA itself that currently dominate. However both experimental drugs have serious side effects because they interfere with the body's immune system and the companies have to convince physicians and investors the balance of risk and benefit stacks up. MS can cause mild symptoms in some people and permanent disability in others. Symptoms may include numbness or weakness in one or more limbs, partial or complete loss of vision, tingling or pain, an electric-shock sensation with certain head movements, tremors and an unsteady gait. Source: Yahoo! News � 2010 Reuters Limited. (22/02/10)

Marijuana has therapeutic value for pain-related medical conditions such as Multiple Sclerosis

Sat, 20 Feb 2010 01:42:00 EST

Researchers from the University of California�s Center for Medicinal Cannabis Research (CMCR) have found �reasonable evidence that cannabis is a promising treatment� for some specific, pain-related medical conditions. Their findings, presented today to the California legislature and public, are included in a report available on the CMCR web site at http://www.cmcr.ucsd.edu. �We focused on illnesses where current medical treatment does not provide adequate relief or coverage of symptoms,� explained CMCR director, Igor Grant, MD, Executive Vice-Chair of the Department of Psychiatry at the UCSD School of Medicine. �These findings provide a strong, science-based context in which policy makers and the public can begin discussing the place of cannabis in medical care.� Researchers have completed five scientific clinical trials, with more in progress. These studies showed that cannabis can be helpful in easing pain in selected syndromes caused by injury or diseases of the nervous system and possibly for painful muscle spasms due to multiple sclerosis. �These scientists created an unparalleled program of systematic research, focused on science-based answers rather than political or social beliefs,� said Senator John Vasconcellos, original author of The Medical Marijuana Research Act of 1999 (SB847) which led to the creation of the CMCR. Study results have been published in high-impact medical journals, garnering national and international attention which prompted leading experts to come together and foster scientific dialog on the possible uses of cannabis as a therapeutic agent. More study will be necessary to figure out the mechanisms of action and the full therapeutic potential of cannabinoid compounds, according to the UC researchers. About The Center for Medicinal Cannabis Research The CMCR was created in 2000 (through the passage of SB847) to conduct clinical and pre-clinical trials of cannabinoids, including smoked marijuana, to provide evidence, one way or the other, to answer the question �Does marijuana have therapeutic value?� The program�s purpose is to oversee objective, high-quality, medical research that would enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent. The project was never to be construed as encouraging or sanctioning the social or recreational use of marijuana. Source: University of California � 2010 UCSD Medical Center. (20/02/10)

Exercise has protective effect on brains of multiple sclerosis patients

Fri, 19 Feb 2010 05:10:00 EST

Exercise is good for the brains of patients with multiple sclerosis, a new study has found. In the new study, researchers found that highly fit multiple sclerosis patients performed significantly better on tests of cognitive function than similar less-fit patients. In addition, MRI scans of the patients showed that the fitter MS patients showed less damage in parts of the brain that show deterioration as a result of MS, as well as a greater volume of vital gray matter. �We found that aerobic fitness has a protective effect on parts of the brain that are most affected by multiple sclerosis,� said Ruchika Shaurya Prakash, lead author of the study and assistant professor of psychology at Ohio State University. �As a result, these fitter patients actually show better performance on tasks that measure processing speed.� The study, done with colleagues Robert Motl and Arthur Kramer of the University of Illinois and Erin Snook of the University of Massachusetts, Amherst, appears online in the journal Brain Research and will be published in a future print edition. The study involved 21 women diagnosed with relapsing-remitting MS. They were compared with 15 age- and education-matched healthy female controls. The study assessed fitness, cognitive function, and structural changes in all participants. Source: Health News Copyright� 2010 Taragana (19/02/10)

Blood lipids, homocisteine, stress factors, and vitamins in clinically stable multiple sclerosis patients

Fri, 19 Feb 2010 03:25:00 EST

Multiple Sclerosis (MS) patients present a decrease of antioxidants and neuroprotective and immunoregulatory vitamins and an increase of total homocysteine (tHcy), cholesterol (CHL), HDL-cholesterol, and of cellular stress markers, variably associated with the different phases of the disease. We compared the blood levels of uric acid, folic acid, vitamins B12, A, and E, tHcy, CHL, HDL-cholesterol, and triglycerides in forty MS patients during a phase of clinical inactivity with those of eighty healthy controls, matched for age and sex. We found higher levels of tHcy (p = 0.032) and of HDL-cholesterol (p = 0.001) and lower levels of vitamin E (p = 0.001) and the ratio vitamin E/CHL (p = 0.001) in MS patients. In conclusion, modifications of some biochemical markers of cell damage were detected in MS patients during a phase of clinical inactivity. Authors: Giuseppe SalemiMaria Concetta GueliFrancesco VitaleFloriana BattaglieriEgidio GuglielminiPaolo RagoneseAngela TrentacostiMaria Fatima MassentiGiovanni SavettieriAntonino Bono Source: 7thSpace Interactive � 2010 7thSpace Interactive (19/02/10)

CCSVI and Multiple Sclerosis: Integrating New Data to Help Guide Actions

Thu, 18 Feb 2010 02:13:00 EST

Author: Ashton Embry, Direct-MS (www.direct-ms.org) Summary The recent scientific results on CCSVI and MS from both the University of Buffalo and Georgetown University have essentially left very little doubt that CCSVI is a causal factor in MS in the majority of, but not all, cases. Furthermore, persons with MS with more disability are much more likely to also be affected by CCSVI and thus there is little question that CCSVI accelerates the MS disease progression. Given the above, every person with MS should be tested for CCSVI. If CCSVI is detected, it should be treated as soon as possible. Persons with MS do not have the luxury to wait five to ten years for research to prove what is reasonably well established at present. Nutritional strategies which counter CCSVI, BBB breakdown and autoimmune reactions are essential both before and after CCSVI treatment. Full article : CCSVI and Multiple Sclerosis: Integrating New Data to Help Guide Actions

Multiple sclerosis sufferers lobby for research into radical new treatment

Wed, 17 Feb 2010 06:18:00 EST

A group of local multiple sclerosis sufferers are urging residents to lobby their MP to support a radical new treatment for the chronic illness. The 20-strong group, which meets at the Multiple Sclerosis Forum at the Sanctuary of Healing, Langho, want more research into the theory MS is a vascular disease that can be treated by a simple surgical procedure. They are asking people to send a letter, which the group has compiled, to their local MP asking for pressure to be placed on the Minister of Health to sanction vascular scans and follow-up treatments for all MS patients. The theory that MS is a vascular disease that can be treated with angioplasty, which clears blockages in veins, is the work of Italian Dr Paolo Zamoni. His early findings suggest MS may, in fact, be a condition called CCSVI, which stands for chronic cerebro-spinal venous insufficiency. Dr Zamboni believes CCSVI causes veins in the neck and upper chest to twist, narrow or become blocked; in some cases, these veins never form at all. The result is poor blood drainage from the brain. He found that more than 90% of patients with MS have these malformed veins, and improper blood flow from the brain. This theory is a radical departure from current thinking and many in the medical community remain sceptical of Dr Zamboni's work. However, local MS sufferers who are members of the Forum think no time should be wasted and more research should be conducted. Forum spokeswoman Julie Hitchen explained: "The MS Society UK is very sceptical and dragging their feet, with no plans for research into CCSVI, although there are now 10 planned projects worldwide. "We are asking everyone affected by MS, their families, friends, MPs, the media and the Great British public for their support in lobbying the Minister of Health to sanction vascular scans and the follow-up treatment for all MS patients in the UK." The letter can be downloaded from the MSRC website at http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=2964 A petition calling for Prime Minister Gordon Brown to make the CCSVI procedure available in the UK can also be signed at http://petitions.number10.gov.uk/CCSVINOW/ Source: The Clitheroe Advertiser & Times �2010 Johnston Press Digital Publishing (17/02/10)

Migraine tied to raised Multiple Sclerosis risk

Wed, 17 Feb 2010 02:02:00 EST

Migraines are more common in women with multiple sclerosis (MS) than in those without the disease, new research shows. The study looked at close to 117,000 U.S. women participating in the Nurses� Health Study II, including 18,000 who had been diagnosed with migraine at the start of the study. The women were assessed every two years over a 16-year period. Of the 375 women who developed MS during the study, 82 had been diagnosed with migraine when the study began. The researchers determined that women with a migraine diagnosis at the start of the study were 47 percent more likely to develop MS than other women. The risk was the same regardless of age, vitamin D levels, body mass index, smoking status or where the women lived. This is the first large-scale study of its kind to examine the association between migraine and MS. The findings were released online Feb. 16 and are scheduled to be presented at the American Academy of Neurology�s annual meeting in Toronto in April. �While having a history of migraine diagnosis was linked to MS, women with migraine need to know that over 99 percent of them will never develop MS, thus having migraine should definitely not be a reason to worry about getting MS,� study author Dr. Ilya Kister, of the New York University School of Medicine, said in a news release from the American Academy of Neurology. �More research is needed since it�s still not known whether migraine is a risk factor for developing MS or if it is a condition that occurs at the same time as MS,� Kister added. Source: Health.com � 2010 Health Media Ventures, Inc (17/02/10)

Will drug companies censor possible MS cure?

Tue, 16 Feb 2010 16:57:00 EST

By Sheila Casey A former vascular surgeon from the University of Ferrara in northern Italy has apparently cured his wife and 65 other people of multiple sclerosis (MS) by using balloon angioplasty to open the narrowed veins in their necks. All of the MS patients who have had Paolo Zamboni�s procedure have remained attack-free, as long as their neck veins remained open. But if their veins close up again, their MS symptoms return. Zamboni began hunting feverishly for the cause of MS after his wife was diagnosed with the disease at age 37 and began to deteriorate. MS patients often lose the ability to walk, to talk, to feed themselves, and even to swallow. Scientists have known for more than 100 years that MS patients had excess iron in their brains, but assumed it was a byproduct of the disease. Zamboni noticed that the excess iron was usually in the core of the brain near a vein. In addition, the lesions that form in the brains of MS patients are grouped near veins. Using ultrasound, Zamboni examined the neck veins of MS patients and compared them to the veins of healthy people or those with other neurological diseases. He found that nearly 100% of the MS patients had significant narrowing in the veins that should be carrying blood from the brain back to the heart, while none of the other subjects had this narrowing. In addition, there was a relationship between the amount of narrowing and the severity of disease, with patients with only one blocked vein suffering milder disease and those with two or more blocked veins suffering more severely. He also found narrowing in the central vein that goes down to the heart through the chest, and patients with narrowing there often had the most serious form of MS, known as primary progressive. They deteriorate very rapidly, with no remissions. Zamboni reasoned that the blood that was being forced back into the brain, (because it could not drain as it was supposed to) was leaving behind excess iron, as well as forcing immune cells through the blood-brain barrier and initiating an auto-immune response. Zamboni termed the condition CCSVI, or Chronic Cerebro Spinal Venous Insufficiency. When he showed his findings to some neurologists, they were excited. But, Zamboni says, when he suggested a method to treat the condition, their enthusiasm waned markedly. Zamboni hypothesized that opening up blocked veins with balloon angioplasty � the same procedure used to open blocked blood vessels in cardiac patients � and allowing the blood to drain normally, would stop the build-up of iron in the brain and stop the progression of the disease. He teamed up with vascular surgeon R. Galeotti, and they operated on 65 MS patients with a procedure now dubbed the �Liberation Treatment.� Surgeons thread a thin wire through the vein and into the patient�s neck, where they expand a small balloon at the stricture to open the closed vein. Within seconds, they see the blood begin flowing normally again. All of the 65 patients have shown significant improvement, some immediately. Jeff Beale, an Emmy Award winning music composer, was the first American to have the procedure. He relates that, as the doctors were opening his veins, he felt �the lights come on.� He is now able to perform duets with his son, help his son with his homework, and has the energy to get through the day � whereas before he was continually sidelined by soul-crushing fatigue.Other patients have exclaimed, within 20 minutes of having the procedure, �I can feel my hands!� Within ten days, one woman regained use of her legs. Their health often continues to improve over the following months, with some patients returning to full health and no sign of disease at all. Others do not recover their former capacities, but suffer no new attacks. Zamboni said: �if you maintain open veins, you will not have more attacks, and you will not have active lesions.� Zamboni�s wife Elena was one of the first to have her veins �liberated,� and now, two years later, she has had no more attacks and is considered neurologically normal. �This, for me, is the best prize,� says Zamboni. The results of Zamboni and Galeotti�s study were published in The Journal of Vascular Surgery on November 24, 2009, and the response from MS patients has been overwhelming. Zamboni has been deluged with calls and emails from patients desperate to have the procedure before their condition degrades further. But the response from the MS Societies in both the US and Canada has been dismissive, with the Canadian society urging patients to �not abandon the treatment they are on,� and the US society issuing the following statement: �At the present time, there is insufficient evidence to suggest that this phenomenon is the cause of MS.� They have discouraged patients from seeking treatment, or even getting tested to see if their veins are blocked. When I called the press contact at the National MS Society to ask about CCSVI, I was told that she was busy working with ABC on a story about exciting new oral therapies for MS, and that I could find all I needed about CCSVI on their website. On the society�s webpage titled �Intriguing Leads on the Horizon,� no mention is made of CCSVI. There has been scant coverage of Zamboni�s discovery in the mainstream media. A search for �Paolo Zamboni,� on the websites for The New York Times, Washington Post, LA Times, CNN and MSNBC brings up, again and again, �no results found,� or �no relevant documents.� A Swiss blog called The Daily Bell opines about this news blackout with: �It is too often the same weary story. Establishment scientific institutions and their planetary satellites - non-profits, etc. - huddle together to keep out anything that remotely challenges business as usual. Have you read about this potential MS cure in manifold versions in the mainstream press? You would think that journalists would leap at the opportunity to cover this astonishing research. Maybe there is nothing to this, but mainstream media silence, as usual, seems deafening.� Exempt from this criticism are a few outlets: The Globe and Mail & W5 TV in Canada, and The Huffington Post�s Erika Milvy, who wrote: �The pharmaceutical industry stands to lose a lot if Zamboni�s one-time treatment pans out. The most common drug therapies for MS cost about $30,000 a year. And there are well over 100 medications for various MS symptoms�On one MS forum is a link to another pharma-gate headline: �Big Pharma�s Crime Spree�, in which the reporter for Bloomberg Markets Magazine assesses that �finding cures is not even remotely a consideration by pharmaceutical executives.� Newly radicalized MS patients are outraged at the media blackout and are banding together to publicize Zamboni�s treatment and help each other find doctors who will test their veins. A search for CCSVI on Facebook brings up 21 recently formed groups with names like �M.S. (Millions Strong to raise awareness of C.C.S.V.I.)� An MS patient named Andrea has created a YouTube channel called MS Vlog Support Group. In a plaintive speech to the camera, she asks. �Where is the news coverage of this? I don�t understand why it�s not all over the place. It boggles the mind.� As has been seen with numerous other diseases, those who make their living from people being sick are far more interested in treating symptoms than in effecting a cure that would have the patient walk out the door and never come back. Evidently these groups � the nonprofit MS societies, neurologists who specialize in treating MS and, most importantly, the pharmaceutical companies, who sold $8.2 billion in MS drugs in 2007 � have the power to suppress the news about this astonishing development. The possible threat to their livelihoods apparently trumps the value of returning health and hope to the two and a half million people worldwide who suffer from MS. Sheila Casey is a DC based journalist. Her work has appeared in The Denver Post, Reuters, Chicago Sun-Times, Dissident Voice and Common Dreams. Source: Zimbio � 2010 - Zimbio, Inc.

Add-On Daclizumab (Zenapax) may reduce MS disease activity more than Interferon Beta alone

Tue, 16 Feb 2010 06:01:00 EST

Add-on daclizumab treatment might reduce multiple sclerosis disease activity more than standard interferon beta treatment alone, according to a study published online first and appearing in the April edition of The Lancet Neurology. Daclizumab has reduced multiple sclerosis disease activity in previous non-randomised studies. In the current study, John W. Rose, MD, Neurovirology Research Laboratory, VA Medical Center, Salt Lake City, Utah and colleagues aimed to assess whether daclizumab reduces disease activity in patients with active relapsing multiple sclerosis who are receiving standard interferon beta treatment. The international, multicentre, phase 2 study randomised 230 patients with active relapsing multiple sclerosis who were taking interferon beta to receive add-on subcutaneous daclizumab 2 mg/kg every 2 weeks (interferon beta and high-dose daclizumab group; n = 75), daclizumab 1 mg/kg every 4 weeks (interferon beta and low-dose daclizumab group; n = 78), or interferon beta and placebo for 24 weeks (n = 77). The primary endpoint was total number of new or enlarged gadolinium contrast-enhancing lesions measured on brain magnetic resonance imaging (MRI) scans every 4 weeks between weeks 8 and 24. Effects of daclizumab on prespecified subsets of immune system cells and immune system response were assessed in an exploratory substudy. The adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 4.75 in the interferon beta/placebo group compared with 1.32 in the interferon beta plus high-dose daclizumab group and 3.58 in the interferon beta plus low-dose daclizumab group. In the substudy, daclizumab was not associated with significant changes in absolute numbers of T cells, B cells or T-cell proliferative response compared with interferon beta alone. The number of CD56bright natural killer cells was 7 to 8 times higher in both daclizumab groups than in the interferon beta/placebo group. Common adverse events were equally distributed across groups. "This study provides confirmatory data that daclizumab treatment causes an expansion of CD56bright natural killer cells and adds support to the theory that expansion of CD56bright natural killer cells might mediate some of the effects of daclizumab on reducing multiple sclerosis lesion activity," the authors wrote. "In addition to the results of previous trials of daclizumab in multiple sclerosis, several lines of evidence have suggested a potential immunoregulatory function for CD56bright natural killer cells: they are expanded during conditions of natural immune tolerance -- for example, pregnancy." "This randomised controlled trial indicates that daclizumab can reduce new lesion formation in relapsing multiple sclerosis compared with interferon beta alone...Multiple sclerosis treatments that have the potential to improve in risk-benefit ratios when compared with available treatments are needed; thus, additional studies to define the long-term clinical risks and benefits of daclizumab are warranted." In an accompanying comment, Olaf St�ve, MD, and Benjamin M. Greenberg, MD, Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Texas, said: "All clinical and paraclinical evidence suggests that daclizumab mediates its beneficial effects at least partly through expanding regulatory CD56bright natural killer cells. It might now be time to explore further how these cells can be expanded in patients by other means... Identifying the physiological mechanism or mechanisms that lead to the expansion of these cells during disease remission might prove crucial in further understanding disease mechanisms and in developing novel therapeutics." Source: Doctors Guide Channels (c) 1995-2010 Doctor's Guide Publishing Limited. (16/02/10)

New diagnostic criteria for Multiple Sclerosis published

Mon, 15 Feb 2010 05:30:00 EST

Investigators are proposing new diagnostic standards for multiple sclerosis in clinically isolated syndromes. Their criteria are less stringent than other proposals and are designed to improve sensitivity to promote early diagnosis. The authors report they wanted to simplify existing diagnostic criteria for multiple sclerosis. The group, led by Xavier Montalban, MD, from the Hospital Universitari Vall d'Hebron, in Barcelona, Spain, suggests current recommendations are complex and that "a good working knowledge of them is not always evident even among neurologists and neuroradiologists." They point out that multiple magnetic resonance imaging (MRI) examinations are often needed to achieve an accurate diagnosis. "This provides an incentive for continued efforts to refine the incorporation of MRI-derived information into the diagnostic workup of patients presenting with a clinically isolated syndrome," they note. The new criteria appeared in the February 2 issue of Neurology. Recommendations �Clinically definite multiple sclerosis can be confirmed if a MRI is performed at any time demonstrating dissemination in space and showing at least 1 or more asymptomatic gadolinium-enhancing and nonenhancing lesions. �Patients without any enhancing or with all enhancing lesions would require a new MRI to demonstrate new T2 or gadolinium-enhancing lesions. �Patients with an abnormal MRI performed at any time, but not showing dissemination in space or time, would require follow-up imaging. "We recommend 1 dissemination in space criterion," the authors note. This would represent 1 or more asymptomatic T2 lesions in 2 or more of 4 locations considered characteristic for multiple sclerosis in previous MRI criteria � juxtacortical, periventricular, infratentorial, and spinal cord. "We recommend 2 dissemination in time criteria," they add, and call for the presence of at least 1 or more asymptomatic gadolinium-enhancing and nonenhancing lesions irrespective of the time of the scan and the presence of a new T2 or gadolinium-enhancing lesion compared with a previous scan. Asked by Medscape Neurology to comment on the new criteria, Gary Birnbaum, MD, from the Minneapolis Clinic of Neurology in Golden Valley, Minnesota, raised some concerns about the effect these recommendations could have. "The proposed criteria are less stringent than other criteria, possibly increasing the sensitivity of detecting conversion to clinically definite multiple sclerosis, but possibly decreasing the specificity of the changes," he said. "This will need to be monitored carefully." Increasing the Risk for Misdiagnosis Dr. Birnbaum says the data supporting early treatment of multiple sclerosis are good; however, he suggests that not all patients with clinically isolated syndrome need, or necessarily benefit from, treatment with disease-modifying therapies. "Indeed, recent long-term data show that more than 30% of persons with 'high-risk' MRI changes do not have significant disease after 20 years of follow-up," he said. "There may not be a great urgency for establishing a diagnosis of clinically definite multiple sclerosis in a significant proportion of individuals with clinically isolated syndrome, especially if the specificity of criteria are less stringent � increasing the risk of misdiagnosis." Dr. Birnbaum points out there are many disease-modifying therapies already approved for the treatment of patients with clinically isolated syndrome. "If a physician feels there is a need to begin treatment early, conversion to clinically definite multiple sclerosis is not necessary to prescribe such agents," he said. More Study Needed Dr. Birnbaum emphasizes that having less stringent MRI criteria for establishing disease progression may not be necessary and could increase the risk of treating people with diseases other than multiple sclerosis. Ben Thrower, MD, a neurologist and senior medical advisor for the Multiple Sclerosis Foundation, said he agrees there are risks involved in early diagnosis. This could lead to inaccurate diagnosis or patients starting therapy with expensive and inconvenient medications, he suggests. However, Dr. Thrower also acknowledges the benefits of early diagnosis, including peace of mind for patients and families dealing with unexplained symptoms. He points to data suggesting fewer relapses and new MRI lesions in those who start therapy sooner. "These new proposed guidelines offer the possibility of using a single MRI to fulfil diagnostic criteria," Dr. Thrower said. "If the brain MRI shows lesions with and without active inflammation, this would demonstrate dissemination in time and space." Dr. Thrower says the new criteria will need to be studied further and compared with existing McDonald criteria to determine whether they are sufficient. Dr. Montalban and his team acknowledge that testing these criteria in new, prospectively followed clinically isolated syndrome cohorts is needed. They also point out that scans in most studies have been performed on 1.5-Tesla or lower field-strength scanners using conventional T2-weighted spin echo or fluid-attenuated inversion recovery sequences. They note, "The impact of 3 Tesla or higher field MRI findings or other MRI sequences on diagnosis will have to be considered in the future." Dr. Xavier Montalban has received support from Novartis, Teva, Merck, Biogen Idec, Bayer, Schering Pharma, Sanofi-Aventis, Almirall, Eli Lilly, Genentech, Genzyme, Wyeth, and Fundaci� Esclerosi Multiple. Source: Medscape Today � 1994-2010 by WebMD LLC (15/02/10)

Possible MS 'cure' comes to Britain

Sun, 14 Feb 2010 03:42:00 EST

British doctors are set to offer patients a ground-breaking treatment for the devastating nerve disease �multiple sclerosis. An Italian doctor has successfully treated MS patients with pioneering surgery to widen narrowed veins. Now specialists in this country are poised to use the same procedure. A private clinic said last night that it would offer the treatment within a matter of weeks in Glasgow and London. Dr Tom Gilhooly, of the Essentials Clinic, said: �The consultants we have been speaking to use this type of procedure elsewhere in the body and so are happy to treat MS patients with narrowed veins.� Until now doctors have believed MS is caused by a faulty immune system. But some experts are now convinced that damage to the nervous system may instead be caused by poor blood flow in narrowed veins in the chest, neck and head. This allows toxins to break through what is known as the blood-brain barrier to attack nerves in the brain. The solution, say surgeons, is to widen the veins with keyhole surgery using a balloon or thin metal tubes known as stents. Both techniques are already used to treat narrowed heart arteries. The discovery was made by Italian vascular surgeon Professor Paulo Zamboni, who cured his paralysed wife of MS five years ago using vein-widening surgery. Dr Zamboni says scans show the vast majority of patients with MS suffer from narrowed veins. New research backing his findings was released yesterday by doctors at the University of New York. They found the same vein narrowing when they scanned MS patients. Singer Amy Winehouse�s mother Janice, 52, who suffers MS, said: �This is very promising. I would like to find out if I could be a candidate for treatment.� Alex Gibbs, 38, is convinced the pioneering surgery has stopped her MS in its tracks. Mrs Gibbs, of Chelsea, travelled to Stanford University Hosp�ital in California for the operation. �The effect was immediate,� she said. �I was able to walk straight away and found I was able to sleep through the night because my leg spasms had gone. I haven�t felt as well as I do now since before I was diagnosed.� Journalist Ian Cook, of Birmingham, flew to Katowice in Poland for the same surgery three weeks ago, paying �3,500 for treatment. �I would say I�ve seen a 20 per cent improvement,� he said. Heart surgeon Gianfranco Campalini, from Belfast, has also been to Poland for treatment. He said: �I saw almost straight away an improvement in my condition.� Helen Yates, of the Multiple Sclerosis Resource Centre, said: �We are delighted that UK patients will not have to travel abroad if facilities are set up in this country. This could be a major breakthrough. If proved correct it turns the whole theory of what causes MS on its head.� But the Multiple Sclerosis Society said the jury was still out and more research was needed before the theory could be widely accepted. Source: Express.co.uk �2006 Northern and Shell Media Publications (14/02/10)

The science and politics of CCSVI and Multiple Sclerosis

Sat, 13 Feb 2010 08:57:00 EST

by Dr. Lorne Brandes The headline over the Feb. 10, 2010 news release from the University of Buffalo, �First blinded study of venous insufficiency prevalence in MS shows promising results� seemed straightforward and encouraging. The statement went on to explain that, in the initial phase of the 500-patient trial, ultrasound (Doppler) examinations unequivocally showed narrowed neck or chest veins in 62% of patients with MS compared to 26% of normal volunteers. Complete data on these subjects will be presented at the American Academy of Neurology meeting in April. Describing himself as �cautiously optimistic and excited�, the study�s principle investigator, Dr. Robert Zivadinov, went on to say �[the data] show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis.� To most observers, Zivadinov�s preliminary results lend a significant degree of credence to Dr. Paolo Zamboni�s as-yet unproven hypothesis that multiple sclerosis is primarily a vascular, rather than an auto-immune disease. Zamboni has coined the term CCSVI (chronic cerebrospinal venous insufficiency) to describe the toxic backup and leakage of iron-containing blood into the brain resulting from obstructive vein abnormalities in the neck or chest, that he believes is at the root of MS lesions or �plaques�. Yet, the �spin� on the significance of Zivadinov�s findings depends on which news source reported them. For example, The Globe and Mail story header read, �Second MS study finds high rate of blocked veins�, while that in the National Post stated, �Research casts doubt on new MS theory�. Like other major news media, including the BBC , London�s Daily Telegraph, and the Canadian Press , The Globe and Mail report, written by Caroline Alphonso, limited itself to a factual report on the Buffalo results, and included comments on the inherent weaknesses in the studies to date. On the other hand, the National Post story, by Tom Blackwell seemed to display a distinctly negative tone. Yet, that should not come as a total surprise as it was consistent with a previous piece Blackwell wrote in the NP, entitled, �Is new MS research the real thing, or a media-driven frenzy?� It was accompanied by an article, �A cure in sight? Not so fast�, with the sub-heading �Media coverage reeks of typical hope-mongering�, authored by Financial Post editor, Terence Corcoran. What is going on here? All journalists have their expert �sources�. For example, over the years, I have advised CTV�s Avis Favaro, among others. Similarly, readers of Tom Blackwell may conclude that one of his expert sources is Dr. Mark Freedman, head of U. of Ottawa�s MS program. Dr. Freedman�s mainstream orthodoxy in the immunological treatment of MS, and his negative opinion of Dr. Zamboni and CCSVI is well documented. "I think there are going to be millions of dollars spent now to follow a hoax.... If I thought for one instant there was substance to this, I'd be all over it,� Freedman told Blackwell in January, before the interim results came out of Buffalo. And what did Dr. Freedman think of Zivadinov�s new findings? Commenting in Blackwell�s latest NP story on the Buffalo data showing that abnormal veins were between 2 and 3 times more common in MS patients as compared to the nine-to-one ratio reported by Dr. Zamboni, he stated, "The whole notion of cause and effect is out the window." Now, this is a free country where Mark Freedman, Tom Blackwell and Terence Corcoran, are entitled to their opinions. But, should not everyone, especially physicians and scientists, maintain an open mind to new and provocative information? As I noted in a previous posting, history provides us with some very sad examples attendant on the reflexive rejection of new ideas without any thought or inquiry as to their validity. Should we not learn from the past? And if we do not, how will progress be made, especially in science and the treatment of disease? Before giving you my personal thoughts on where we currently stand with CCSVI, it is important to remember that I am an oncologist, not a neurologist, and certainly not an MS expert like Dr. Freedman. However, especially when judging the merit of new theories, sometimes outsiders to a specialty can see the �big picture� with more clarity (and perhaps less bias) than those who are �up close and personal�. And as one who, for over 35 years, has been heavily involved in laboratory and clinical research, I believe I know a thing or two about science and (sadly) the politics of science. First, I continue to believe that the CCSVI theory of MS proposed by Dr. Zamboni is scientifically plausible and deserving of serious and intensive investigation. Those health professionals, and others who, for whatever reason, remain in denial should get over it and commit to finding the answer rather than obstructing progress. Second, I believe that the preliminary findings of Dr. Zivadinov and his colleagues in Buffalo are significant and support a link between MS and CCSVI. However, their early data are not as robust as Dr. Zamboni�s and their study raises many new questions. For example, what is the true incidence of vein abnormalities in MS patients and normal controls? Does MS only occur or progress in people with more severe types of venous obstruction? While we do not yet know, it is important to understand that Dr. Zamboni used both ultrasound and the direct injection of dye into veins (called venography) to obtain his results. The first phase of the Buffalo study employed only ultrasound. Of the two tests, venography is more sensitive and definitive in demonstrating anatomical abnormalities and blockage in veins, akin to angiograms being the �gold standard� in diagnosing coronary artery disease in the heart. In acknowledging this important difference, Dr. Zivadinov has stated that more �advanced diagnostic tools� (including, I suspect, venography) will be used to test the next 500 subjects in his study. Finally, taking into account Dr. Zamboni�s preliminary results, there is no �level 1� evidence that unblocking veins is an effective treatment for any type of MS. As Paolo Zamboni himself has stated, the answer to that most important question will require further independent assessment and will take time, probably 3 to 5 years at a minimum, to answer. Until then, I strongly advise that patients wishing to have their veins tested, and an unblocking procedure performed, should do so only in approved clinical trials that are properly designed to insure their safety and provide an accurate assessment of efficacy. In this respect, Canadian MS patients are especially fortunate that centres at McMaster and UBC already have teams of neurologists, radiologists and vascular surgeons who are committed to carrying out these complex studies. While they have our thanks and best wishes for success, they also desperately need our donations. Please be generous and help if you can. Source: CTV News � 2010 CTVGlobeMedia (13/02/10)

Preliminary results of preoperative diagnostics and endovascular treatment for CCSVI

Sat, 13 Feb 2010 04:57:00 EST

Preliminary results of preoperative diagnostics and endovascular treatment for CCSVI Marian Simka EuroMedicVascular and Endovascular Surgery Department Katowice Poland http://www.ms-mri.com/docs/Simka-hamilton%20-ccsvi-1.pdf

Blocking cell movement for possible Multiple Sclerosis treatment

Thu, 11 Feb 2010 06:51:00 EST

University of Adelaide researchers in Australia are finding new ways to block the movement of cells in the body which can cause autoimmune diseases and the spread of cancer. Led by Professor of Immunology Shaun McColl, the researchers have identified molecular "receptors" on the surface of cells which are involved in helping cells migrate to sites where they can cause disease. "A number of diseases like cancer and autoimmune diseases, such as multiple sclerosis and arthritis, involve the inappropriate migration of cells," says Professor McColl. "Our research shows that these receptors which help the cells migrate can be blocked pharmacologically, preventing the cell migration which causes the disease." The researchers have identified a number of such receptors in multiple sclerosis and have developed potential therapeutic drugs that could control this disease, and other autoimmune diseases. They are also in the process of identifying receptors on the surface of metastatic cancer cells. "These are exciting research outcomes and will offer new treatments for these diseases which affect millions of people," says Professor McColl. Professor McColl is Head of Chemokine Biology, Deputy Head of the School of Molecular and Biomedical Science and Deputy Executive Dean of the Faculty of Sciences at the University of Adelaide. Source: Science Daily � 1995-2009 ScienceDaily LLC (11/02/10)

Drinking milk during pregnancy lowers risk of multiple sclerosis in children

Wed, 10 Feb 2010 08:49:00 EST

Drinking milk during pregnancy reduces the chances of development of multiple sclerosis in children in their later life, says a new research study presented at the American Academy of Neurology�s annual meeting in Toronto, Canada. The researchers from the Harvard School of Public Health in Boston, US found that children born to pregnant mothers who drank milk were at lower risk of having multiple sclerosis. This was similar in cases where the mothers took vitamin D during pregnancy as well. Multiple sclerosis is a medical condition where the brain nerves are damaged and fails to communicate with the spinal cord. It may be seen relapsing in some cases and also show accumulation of the myelin sheaths over time. The common symptoms of this disease are weakness in muscles, spasms and difficulty in movement. A study of 35,794 female nurses whose their mothers provided information about their diet pattern during pregnancy established the link between multiple sclerosis and pregnancy. Out of those nurses who took part in the study, 199 were found to develop multiple sclerosis after a span of 16 years. The risk of multiple sclerosis was seen to be lower by 56 percent in daughters whose mothers drank milk (four glasses everyday) during pregnancy compared to those mothers who drank less than three glasses. The mothers who consumed vitamin D during pregnancy gave birth to daughters with 45 percent lower risk than those whose vitamin D intake was less. The findings of the study can help the mothers start having vitamin D and more milk during pregnancy to avoid their children suffer from multiple sclerosis when they grow up. Source: Bolo Health � 2009 Bolohealth.com (10/02/10)

Leaders from the US National MS Society meet with Dr. Zamboni at NYU-hosted scientific presentation

Wed, 10 Feb 2010 05:35:00 EST

National Multiple Sclerosis Society leaders met with Paulo Zamboni, MD, today in advance of his invited lecture at New York University�s MS Center of Excellence. Dr. Zamboni, of the University of Ferrara in Italy, is a vascular surgeon who has put forth the hypothesis of a connection between CCSVI, or blocked blood flow in the brain, and MS. In meetings and during today�s lecture, Dr. Zamboni suggested that if further evidence supports the link between MS and CCSVI, that its treatment may ultimately add to the arsenal of therapies available for MS. He also emphasized the need for more research on his hypothesis, and noted that it is still not proven whether CCSVI is a cause of MS or possibly a product of MS. Dr. Zamboni also noted that people with MS should remain on their immunomodulatory therapies as has his wife after her endovascular surgery. The National MS Society is aggressively pursuing this potential MS lead by undertaking the funding of new research on CCSVI in MS. Today (February 9) is the deadline for investigators to submit their research applications on this topic to both the National MS Society and the MS Society of Canada. An international panel of experts will conduct an expedited review of the applications, and funding decisions will be announced in June 2010. Source: National US Multiple Sclerosis Society (10/02/10)

Schoolboy�s petition prompts move on Multiple Sclerosis link to vitamin D

Wed, 10 Feb 2010 05:12:00 EST

An international conference is to be held in Scotland to discuss the health effects of vitamin D � thanks to the efforts of a 14-year-old schoolboy. Ryan McLaughlin, from Glasgow, petitioned the Scottish Parliament questioning possible links between vitamin D and multiple sclerosis after discovering that the disease � from which his mother suffers � could be prevalent in Scotland because of vitamin D deficiency caused by a lack of sunlight. The petition called on ministers to produce guidelines on vitamin D supplements for children and pregnant women, and launch an awareness campaign. As a result of his efforts, the Scottish government recognised �an urgent need� to provide information to health professionals and mothers, and is to launch a campaign. Ministers also agreed to host a conference on April 27 to discuss the role of vitamin D. The event, to take place in Glasgow, will be opened by Nicola Sturgeon, the Health Secretary. Leading researchers into links between vitamin D deficiency and multiple sclerosis are expected to attend. Yesterday, as the Public Petitions Committee agreed to close Ryan�s petition, members congratulated him for his achievement. Bill Butler, Ryan�s local MSP, hailed the schoolboy�s effort, saying that �a very great deal of progress� had been made. The Glasgow Anniesland representative praised the way �Ryan and the McLaughlin family have persuaded the government; and the government has listened to the very sensible suggestions contained in the petition. �The government has agreed to a co-ordinated programme of action with NHS Scotland to produce guidance on vitamin D, to educate women on its importance, to consider different messages for different groups of people, and to ensure that health professionals are giving correct and consistent advice to pregnant women and new mothers. Not only should the McLaughlin family be congratulated, but also the government for listening.� He described that as a significant success. An image of Ryan is now featured on promotional literature for the petitions committee. Speaking about the campaign, Ryan said: �After an amazing year in raising both vitamin D and MS awareness, I now have the commitments that I wanted from the Scottish government. �I applaud the positive action taken by the Scottish government and the support from Deputy First Minister Nicola Sturgeon and Shona Robison, Health and Sports Minister.� A spokeswoman for the Scottish government said: �We�re keen to learn all we can about any possible links between vitamin D and multiple sclerosis and are keeping a very close eye on all the emerging evidence.� � Breast cancer is diagnosed more often in the spring and autumn, and less often in the summer, leading researchers to suggest that its season-ality may be connected to vitamin D deficiency. Researchers at the University of South Carolina, who examined 2,921,714 breast cancer cases, also found that the seasonality was increasingly prominent the further away from the equator that the women lived. This implies that lack of sunshine, and therefore vitamin D, was a factor. Source: Times Online Copyright 2010 Times Newspapers Ltd.(10/02/10)

UK firm gets final green light for neurological stem cell trial

Wed, 10 Feb 2010 04:08:00 EST

British biotech company ReNeuron and a team of doctors in Scotland have won final approval to start a pioneering clinical trial to assess whether stem cell therapy can help patients disabled by stroke. The treatment involves injecting neural stem cells developed from human fetuses into patients' brains in the hope they will repair areas damaged by stroke, thereby improving both mental and physical function. The final green light from Britain's Gene Therapy Advisory Committee (GTAC), announced on Wednesday, follows months of delays and questions, reflecting the ground-breaking nature of the research. ReNeuron received an okay from Britain's main drugs watchdog back in January 2009 but still needed a recommendation from the GTAC before it could start the Phase I clinical trial. The first patient in the study is now expected to receive treatment through the National Health Service at the Institute of Neurological Sciences, Southern General Hospital, Glasgow, during the second quarter of this year. In total, 12 patients will get ReNeuron's ReN001 cell therapy between six and 24 months after having an ischemic stroke -- caused by a blockage of blood flow in the brain -- and their progress will be followed for two years. The procedure involves the direct injection of millions of cells into the affected brain region. The initial tests will look primarily at the safety and feasibility of the treatment. If the first study is successful, researchers plan to pursue accelerated clinical development in later-stage clinical trials, focusing initially on more severely disabled stroke patients. About half of all stroke survivors are left with permanent disabilities as a result of brain damage. The potential of different kinds of stem cells -- master cells that can develop into specialized tissue in the body -- is being examined by experts around the world for many diseases. But the technology is controversial, in part because some stem cell lines are derived from embryos or fetuses. ReNeuron had initially hoped to test its stroke treatment in the United States. It decided to switch its efforts to Britain in 2008, however, following delays at the Food and Drug Administration. The group became Europe's first stem cell company to float in 2000, but was taken private in 2003 after a series of clinical setbacks and the bursting of the technology bubble hammered its share price. It relisted in 2005. Source: Reuters Copywrite Thomson Reuters 2010 (10/02/10)

First UK Clinic soon to offer CCSVI testing starts registration

Tue, 09 Feb 2010 10:14:00 EST

Glasgow Health Solutions are actively seeking to offer scanning for CCSVI in the UK in 2010 in both London and Glasgow. The Doppler ultrasound scan required to show the CCSVI abnormalities has been specially adapted and requires specialist training from Prof Zamboni and his team. It is vital to work with the recognised specialists in this field and they hope to have ultrasound technician trained by Dr Zamboni later this year. The cost of the scans in the UK is still to be finalized but should be around 250 to 300 pounds. They are also liasing with intervention radiologists to develop treatment centres in the UK. If you wish to register your interest and be kept informed of these developments you can register your interest in the web site - http://www.essentialhealthclinic.com/website/index.php/contacts Helen Yates, MSRC Chief Executive said: "MSRC is fully supportive of Essential Halth Clinic's efforts to enable scanning for CCSVI in MS patients in the UK. Currently anyone who believes that they have this problem has to go to Europe even just to get scanned, never mind treated. Enabling the scanning to take place here in the UK will represent a big step forward for people affected by Multiple Sclerosis who believe this venous insufficiency problem lies at the root of their MS"

MP calls for abolition of the Multiple Sclerosis drugs risk-sharing scheme

Tue, 09 Feb 2010 04:43:00 EST

The Risk-sharing Scheme, the mechanism that makes disease modifying drugs for MS available on the NHS, was debated in Parliament on 2 February. James Gray MP, Chair of the All Party Parliamentary Group on MS, was very critical of the scheme and of the methodology and conclusions of the recently published two year analysis of the Scheme so far. In the light of the development of oral drugs for MS, he concluded by calling for the abolition of the Scheme. In reply, Health Minister Mike O'Brien drew attention to the reasons for setting up the Scheme and how it makes the disease modifying drugs available on the NHS. When asked about the new, oral drugs for MS, the minister reminded Mr Gray that these have yet to receive a licence and be assessed by NICE. But if they are recommended by NICE, the MS risk-sharing scheme will not detract from their appropriate use. Pam Macfarlane, Chief Executive of the MS Trust, said "This statement by Mr Gray must be very disappointing for the dedicated clinicians and the 4,900 people with MS who are currently being monitored and it must also be worrying for approximately 14,000 people currently receiving disease modifying drugs under the Scheme. "Until the oral drugs are licensed and widely adopted, we must ensure that people with MS can continue to have access to the therapies they need and do not end up re-living the problems of the 1990s with postcode prescribing and a lack of MS specialists and clinics." Source: MS Trust (09/02/10)

Centre to test for Chronic Cerebrospinal Venous Insufficiency (CCSVI) and it's possible link to MS

Tue, 09 Feb 2010 02:34:00 EST

One of the first clinics in North America devoted to testing for a vascular condition that some experts believe is linked to multiple sclerosis is set to open later this month in Buffalo, just as scientists are to release more findings on the controversial theory. The Buffalo Neuroimaging Analysis Center (BNAC) has announced that it will begin to offer testing for the newly discovered condition, called chronic cerebrospinal venous insufficiency (CCSVI), in mid-February due to overwhelming demand from MS patients. Italian scientist Dr. Paolo Zamboni believes that CCSVI causes veins in the neck and upper chest to twist, narrow or become blocked; in some cases, these veins never form at all. The result is poor blood drainage from the brain. Zamboni has found that more than 90 per cent of patients with MS have these malformed veins, and improper blood flow from the brain. Due to the overwhelming response to Zamboni's research and to its own study on the condition, the BNAC said it will begin offering diagnostic venous testing to patients beginning in mid-February 2010. Testing will include: An MRI of the brain to measure the level of iron deposits An MRI of the neck to study the jugular, vertebral and other collateral veins A Doppler exam of the head and neck to determine blood flow A follow-up visit with a doctor to discuss the findings News of the findings comes days before scientists from the BNAC release data from their study that includes 500 MS patients who were tested for CCSVI. "What I can tell you today is that the preliminary results are exciting scientifically and will generate a great deal of discussion among our colleagues, the worldwide press, and individuals like you who are following very closely any developments about CCSVI," Dr. Robert Zivadinov said in the BNAC newsletter. Zivadinov said the second phase of the study will include another 500 patients and will "pose new and provocative questions about the CCSVI theory." Scientist welcomes scepticism Zamboni told CTV's Canada AM Monday that he welcomes skepticism about his findings. "This is normal when there is a new finding in science," Zamboni said. "I think that this is positive because it stimulates debate." Zamboni was in Hamilton, Ont., Sunday for a scientific workshop looking into the relationship between MS and CCSVI. Scientists from the United States, Europe and the Middle East reported that they had found CCSVI in more than 95 per cent of MS patients. "The meeting yesterday was quite successful because we met a lot of colleagues from all over the world that are actually working on our theory," said Zamboni, who is a professor of medicine at the University of Ferrara in Italy. According to Zamboni, a surgical procedure to restore proper blood flow, which he dubbed the "Liberation treatment," can reduce MS symptoms. In a study of 65 patients who underwent the procedure, released in the Journal of Vascular Surgery, Zamboni says that 50 per cent of patients with the most common form of MS were relapse-free for at least 18 months. In a control group of MS patients who did not undergo the procedure, only 27 per cent went 18 months without an MS attack. Additionally, only 12 per cent of patients in the surgery group had brain lesions -- a sign of active disease -- compared to 50 per cent in the control group. Research will take time Dr. Mark Haacke, director of the imaging division in the school of biomedical engineering at McMaster University, organized the weekend conference and said "no one is claiming it's a cure." "It's a cardiovascular problem first, it may be related to MS, it may cause MS -- but we don't know all those answers yet," he told CTV.ca. "That's going to take time to do very careful research to evaluate those MS patients that do get the operation. "Do they get better? Do they stay the same? Do their lesions go away? Or do they at least not get worse. (It) may take years and years to really determine the effectiveness of this surgery." MS societies around the world have responded with funding for research into CCSVI. The Italian Multiple Sclerosis Foundation has allocated up to $4.5 million for research and the MS Society of Canada has called for applications for grants for those studying Zamboni's findings. Charity Intelligence Canada, a group that provides donors with research and information, called for additional research and funding into Zamboni's findings on Monday. The group said Canadians donated $62 million to MS-related charities in 2009, and said "supporting CCSVI research presents an opportunity for donors to have high impact in their giving." "Donors wanting to support CCSVI research in Canada should donate directly to St. Joseph's Healthcare and McMaster University in Hamilton, Ontario and University of British Columbia, designating their donations to CCSVI research," the group said in a statement. However, experts have warned that the findings are far from being validated and those with MS should continue with their current treatment. "Although the early data are of great interest, it is important to acknowledge that the concept of CCSVI as a cause of MS and the use of stents or balloons to widen veins as treatments, are ideas that are far from being accepted by most researchers in the field," the MS Society of Canada says on its website. Experts have expressed concern that the initial excitement over the new procedure was leading some to drop their current treatment. "To people with MS we say: don't abandon the course of treatment that you have started," Yves Savoie, the president and CEO of the MS Society of Canada told CTV News in November. "Those treatments have been proven in large trials to be effective in reducing the burden of disability that comes with MS." Haacke says that since most MS patients have MR scans performed, clinicians should consider performing additional scans for CCSVI. "It's important for clinicians to begin to realize that they should be taking some time clinically � not on the research side � to scan their patients and find out if this is a problem," he said. Canada has one of the highest rates of MS in the world, affecting between 44,000 to 78,000 in the country. Source: CTV News � 2010 CTVGlobeMedia (09/02/10)

New theory suggests Multiple Sclerosis treatable

Mon, 08 Feb 2010 09:27:00 EST

A controversial theory touting multiple sclerosis as a vascular disease is a "step in the right direction" but not a panacea, says a McMaster University professor. Dr. Mark Haacke, director of the imaging division in the school of biomedical engineering at Mac, says it would not be a good idea for people to call the theory by Dr. Paolo Zamboni a cure for the disease. "I think the key here is that these people who've had the disease, it may take a long time for the problems in the brain to clear up," said Haacke, who is also a professor at Wayne State University. "They may still require the conventional treatments that they're getting now." Zamboni has proposed that multiple sclerosis (MS) is a vascular disease that can be treated, rather than an auto-immune disorder with few treatment options. His theory is called chronic cerebrospinal venous insufficiency. He was in Hamilton yesterday for a scientific workshop at St. Joseph's Healthcare's Charlton Avenue site. About 200 people, a mix of professionals, doctors, scientists, and people who suffer from MS attended. The workshop was a closed event. "I think it went very well," said Kevin Smith, CEO of St. Joseph's Healthcare. "Obviously this was an opportunity for the scientific community to come together and chat with Professor Zamboni about his observations and others who've been involved in replicating his observations." In addition to Zamboni, those in attendance say information from others doing similar work around the globe was presented. Dr. Ian Rodger, vice-president of research at St. Joe's, said the workshop heard "undeniably" that there are patients who have had the medical procedure that is done based on his theory (it unclogs veins to the brain and improves blood flow) who quickly had relief from some MS symptoms such as fatigue and buzzing in their ears. "What we don't know is how long does it last? ... No one's been following it long enough. But I think at the end of it all, (it's) highly encouraging that the data is steadily coming out." Rodger also said Zamboni has not presented something "mind-shattering" as talk about problems with blood vessels in the brain leading to MS was around 100 years ago. Smith said the MS Society of Canada has now put out a call for proposals to research the subject further. St. Joe's and McMaster will be involved in bidding for the chance to conduct the study, he said. St. Joe's has currently done some imaging work around the theory and was swamped with 22,000 request from MS patients wanting to take part. Source: Thespec.com � Copyright Metroland 2010 (08/02/10)

African/Americans with MS have more severe symptoms, decline faster than whites

Mon, 08 Feb 2010 05:08:00 EST

Fewer African Americans than Caucasians develop multiple sclerosis (MS), statistics show, but their disease progresses more rapidly, and they don't respond as well to therapies, a new study by neurology researchers at the University at Buffalo has found. Magnetic resonance images (MRI) of a cohort of 567 consecutive MS patients showed that blacks with MS had more damage to brain tissue and had less normal white and grey matter compared to whites with the disease. Results of the study appear in the Feb. 16 issue of the journal Neurology. Bianca Weinstock-Guttman, MD, UB associate professor of neurology in the UB School of Medicine and Biomedical Sciences, is first author on the study. Weinstock-Guttman directs the Baird Multiple Sclerosis Center in Kaleida Health's Buffalo General Hospital. "Black patients showed more brain tissue damage and accumulated brain lesions faster than whites, along with rapid clinical deterioration," confirms Weinstock-Guttman. "The results provide further support that black patients experience a more severe disease, calling for individualised therapeutic interventions for this group of MS patients." "White matter" refers to the parts of the brain that contain nerve fibers sheathed in a white fatty insulating protein called myelin. The white matter is responsible for communication between the various grey matter regions, where nerve cells are concentrated and where cognitive processing occurs. "Initially, multiple sclerosis was considered primary a white-matter disease," says Weinstock-Guttman, "but today we know that the grey matter may be more affected than white matter." In general, black MS patients tend to have more severe and more frequent attacks, followed by an incomplete recovery even after the first episode. Studies on signs and symptoms of MS among populations have shown that blacks experience gait problems sooner after their diagnosis, show faster cognitive decline than whites with MS, and become dependent on a wheelchair sooner, she notes. The study's MRI scans were conducted at the Buffalo Neuroimaging Analysis Center (BNAC), part of the Jacobs Neurological Institute/UB Department of Neurology. Robert Zivadinov, MD, PhD, a UB associate professor of neurology, is director of the center. Seventy-nine black patients and 488 white patients were entered in the study. Participants were older than 18 and had been scanned within 90 days of their most recent clinical visit. Black participants were significantly younger, and their disease was more severe than white patients, despite having MS for a shorter amount of time. "Results of the MRI scans showed that the aggressive disease process in blacks appears to be associated with increased macroscopic and microscopic tissue damage, as measured by specific MRI parameters," says Weinstock-Guttman. "Based on our MRI findings, a plausible hypothesis that would explain the more aggressive disease in blacks compared to whites with MS may be that blacks have a reduced capacity for remyelination, the brain's ability to repair the protective myelin sheath. However, to confirm this hypothesis, we will need to conduct more longitudinal studies." Murali Ramanathan, PhD, associate professor in the departments of Pharmaceutical Sciences and Neurology in the UB School of Pharmacy and Pharmaceutical Sciences and School of Medicine and Biomedical Sciences, respectively, also contributed significantly to the study. Additional contributors were David Hojnacki, MD, Michael G. Dwyer, Sara M. Hussein, MD, Niels P. Bergsland and Frederick E. Munschauer, MD, former chair of the UB Neurology department, now vice president of U.S. medical affairs for Biogen Idec in Boston, Mass. The study was supported by grants from the National Multiple Sclerosis Society and the UB Pediatric MS Center of Excellence. The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system and its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities. Source: University of Buffalo � 2010 University at Buffalo.(08/02/10)

Test of CCSVI - Multiple Sclerosis theory 'watershed moment' for St. Joe's

Sun, 07 Feb 2010 02:32:00 EST

Finding a treatment for multiple sclerosis holds as much promise for Hamilton as it does for patients. St. Joseph's Hospital is one of just two places in Canada testing Italian vascular surgeon Dr. Paolo Zamboni's controversial theory that MS is a vascular disease -- a radical departure from long-held beliefs that it's an autoimmune condition. The University of British Columbia is the other place. It has brought Hamilton to the attention of the world with about 22,000 MS patients from Asia to Africa to South America to all over the United States and Canada vying to be one of the 100 chosen for the study. It will also recruit 100 healthy people to take part. "This is a watershed moment," said Dr. Ian Rodger, vice-president of research at St. Joseph's Healthcare. "Opportunities like this don't come along very often." Hamilton has the chance because of McMaster's affiliation with Detroit imaging expert Dr. Mark Haacke, who met Zamboni in September when the Italian doctor held a conference about his theory. Zamboni believes the veins draining blood from the brain are blocked and leaking in MS patients. This allows iron to leak into brain tissue and he thinks the buildup causes many symptoms of MS. Zamboni found those veins blocked or malformed in more than 90 per cent of MS patients he studied -- including his wife. Haacke has long researched the role iron plays in MS and is eager to test Zamboni's theory. His main lab is in Detroit but he's also an adjunct professor at McMaster. With eight other Hamilton doctors, he plans to use St. Joseph's MRI, which is twice as strong as traditional machines, to look at the veins in the brains of MS patients and healthy people to see whether there is a difference. Haacke says there has been a lot of resistance to Zamboni's theory -- Chronic Cerebrospinal Venous Insufficiency (CCSVI) -- from medical professionals, particularly neurologists. "It was just so flabbergasting to them," he said. But the idea can't be ignored. "We're going to have 10 years of fascinating research." St. Joseph's, McMaster and Hamilton Health Sciences want to play a big role in that. They don't have funding yet, but are together putting in a proposal to the MS Society of Canada Tuesday for $100,000 a year for two years. Rodger is leading the research and hoping other funders will come forward so that they can do a much bigger study that would produce results in 12 to 15 months instead of two years or longer. Philanthropists and/or their advisors are expected to be at the workshop Zamboni and Haacke are presenting in Hamilton tomorrow. The stakes are high for MS patients, as there are few treatment options. Zamboni performs an experimental surgery similar to angioplasty to unclog the veins and improve blood flow. He says it has worked for his wife and others. Hamilton MS patient Vasilios "Bill" Smyrnios wants to know if that surgery could help him. The 50-year-old who was diagnosed 10 years ago can't walk anymore and has to live in supportive housing. "This disease is relentless," he said. "It keeps getting worse. It has amazed me. I never expected to get like this." He has newfound hope since researching Zamboni's theory. "It was the first thing I've read in a long time that made sense." While St. Joseph's is studying the theory and hosting the conference, it is a long way from endorsing it. "There's a great deal of skepticism about the observational study (that Zamboni did)," said Kevin Smith, CEO of St. Joseph's Healthcare. "A lot of the scientific community has already rejected the view. But it resonates profoundly with patients and families so it's our responsibility to determine if this is more than unusual observation." Source: Thespec.com � Copyright Metroland 2010 (07/02/10)

New study planned to test earlier use of Multiple Sclerosis drug Tysabri

Sun, 07 Feb 2010 01:44:00 EST

Biogen Idec Inc. is planning the first clinical trial that could lead to use of controversial multiple sclerosis treatment Tysabri, sold with Elan Corp, at earlier stages of the disease. The long-term trial, dubbed Surpass, will measure the effectiveness of Tysabri in patients with active MS that have switched from either Teva Pharmaceutical Industries Ltd.'s Copaxone or Rebif, sold by Pfizer Inc. and Germany's Merck KGaA. Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped amid concerns about the risk of a rare brain infection that led to its 18-month market withdrawal beginning in 2005. The study comes after Tysabri brought in more than $1 billion in 2009, and it is part of Biogen's push to accelerate Tysabri's growth. It also comes amid increased competition in MS treatments. Novartis AG and Germany's Merck KGaA could launch oral treatments for the disease this year, a notable advance compared to the injections and infusions required with current drugs. The goal of the Surpass trial is to get physicians to use Tysabri when patients aren't responding to their current therapy, rather than switching them to more mainstream therapies. Beside Copaxone and Rebif, other common options include Biogen's Avonex and Bayer AG's Betaseron, while Tysabri is generally reserved for patients with very aggressive disease or have no other options. "We are trying to establish that there is no use in switching around [prior to using Tysabri]," Biogen spokeswoman Naomi Aoki. The company is signing up sites for the trial and has yet to enroll the first of an estimated 1,800 patients. The study will follow participants for about two years and isn't likely to yield data until 2013 or 2014. If successful, the result should allow Biogen to update Tysabri's label and allow it to market the earlier use to physicians. Source: ADVFN III Copyright 1999-2010 ADVFN PLC (07/02/10)

New FDA warning on Multiple Sclerosis drug, Tysabri, greater number of doses raises risk of brain infection

Sat, 06 Feb 2010 02:12:00 EST

In the latest blow to the controversial multiple sclerosis drug Tysabri, the U.S. Food and Drug Administration announced that it was slapping a new warning on the drug's label. In an advisory sent to health-care professionals and patients, the FDA warned that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but deadly brain infection, increases as more infusions are received. "This is updated information, taking new cases into account," explained Dr. William Sheremata, professor emeritus of neurology at the University of Miami Miller School of Medicine, who gave the drug to the first humans. European patients account for most of the new cases and many of them might have been taking multiple drugs, raising their risk for PML, he added. "This is not new information. We've had this information for a couple of months now [but] the labeling in the past did not make a distinction between the time frames that people were on the drugs," said Dr. John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society. "The risk-benefit ratio continues to be about the same as we anticipated since the time the drug was brought back on the market." Another expert agreed that the clinical picture hasn't been altered by the new label warning. "I think as long as the medication is being prescribed for the appropriate patient with MS, then the new information we have today is not going to alter medication management," said Dr. Jeffrey Tramonte, director of neurology at the Scott & White University Medical Campus in Round Rock, Texas. "Right now, Tysabri is the most efficacious drug that's ever been approved for the treatment of relapsing-remitting MS, which represents 85 percent of all patients out there who have MS," he said. "However, it also carries the single most dangerous risk factor, and that's PML," added Tramonte, who only gives Tysabri if his patients have failed or have severe side effects from conventional immunomodulating drugs. Natalizumab (Tysabri) first received FDA approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed PML. In June 2006, the FDA allowed the drug back on the market, but with strict conditions. According to those revised guidelines, Tysabri can only be administered by approved doctors, at infusion sites and at pharmacies that register and comply with a patient-safety program called CD Touch, designed by drugmaker Biogen Idec and approved by the FDA. The FDA said the new action was based on reports of 31 confirmed cases of PML as of Jan. 21, 2010. Information on the risk will also be included in the patient Medication Guide. However, the FDA did not suggest discontinuing the drug, stating that it "believes that the clinical benefits of Tysabri continue to outweigh the potential risks." The drug was approved to treat Crohn's disease in early 2008. It is also linked with liver damage. Patients do take the drug long-term, Richert said. Source: HealthDay � 2010 HealthDay. (06/02/10)

Glaxo to concentrate on three neurological areas, creating a rare diseases unit

Fri, 05 Feb 2010 01:23:00 EST

Fueled by windfall profits from swine flu vaccine sales, GlaxoSmithKline reported a big spike in revenue for the fourth quarter. But the extra money hasn't stopped the pharma giant from sharpening its budget-cutting axe once again. Glaxo executives this morning outlined an additional 500 million pounds ($791.6 million) of budget cuts as it scales back on R&D. Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer's, Parkinson's and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator. "We are allocating capital to areas where we can get the best return on investment," the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company's workforce that would amount to the "hundreds rather than thousands" in the U.K. "In addition to our existing discovery effort, alternative opportunities need to be explored to make treatments available for rare diseases," says Marc Dunoyer, GSK's president of Asia Pacific and chairman of Japan, who will head the new rare diseases unit. "This complementary approach will combine our existing global expertise with specialist partners. Over time, this new unit has the potential to deliver multiple therapies responding to high medical needs of underserved populations of patients." Source: Fierce Biotech � 2009 FierceMarkets, Inc. (05/02/10)

CCSVI & MS discussed on BBC local Essex Radio morning of 4th February

Wed, 03 Feb 2010 11:35:00 EST

Ben Parker from MS-CCSVI-UK and Helen Yates, MSRC Chief Executive, will be interviewed on BBC Radio Essex tomorrow morning at 7.05 and 8.05 respectively on CCSVI and MS. You can listen live via http://news.bbc.co.uk/local/essex/hi/ or listen anytime via BBC iPlayer - http://www.bbc.co.uk/iplayer/console/bbc_radio_essex/

Compugen discovers CGEN-15001 protein for treatment of autoimmune disorders

Wed, 03 Feb 2010 04:53:00 EST

Compugen Ltd. announced today the discovery and experimental validation of CGEN-15001 for the treatment of autoimmune disorders. CGEN-15001 is the extracellular region of a previously unknown membrane protein in the B7/CD28 family. The existence and potential utility of the newly discovered parent protein from which CGEN-15001 is derived was predicted in silico utilizing Compugen�s LEADS Platform and other proprietary algorithms. Autoimmune diseases develop when defects in the immune system lead the body to attack its own cells, tissues, and organs and include more than 80 chronic, and often disabling, illnesses. Among the most common autoimmune diseases are rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. Collectively, autoimmune diseases are among the most prevalent diseases, affecting an estimated 25 million people in the U.S. CGEN-15001 is a novel soluble recombinant fusion protein corresponding to the extracellular region of the Compugen discovered parent protein. The discovery of the parent protein, which is a membrane protein, was accomplished through the incorporation in Compugen�s LEADS Platform of additional algorithms specifically designed to predict novel members of the B7/CD28 family of co-stimulatory proteins. This approach relied on Compugen�s proprietary understandings and modeling of genomic structure, gene expression, protein structural domains, and cellular localization. Compugen has filed for patent coverage on both the parent protein, which potentially has other medical uses such as a target for antibody therapeutics, and CGEN-15001. The in vivo validation of CGEN-15001 utilized a mouse model of multiple sclerosis, relapsing-remitting experimental autoimmune encephalomyelitis (R-EAE). In this model, administration of CGEN-15001 resulted in potent amelioration of the disease state. These results indicate that CGEN-15001 could have therapeutic utility for the treatment of multiple sclerosis and other autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and type 1 diabetes. Earlier in vitro studies validated the predicted functional activity of CGEN-15001 as a new member of the B7/CD28 family proteins. Professor Stephen Miller from Northwestern University, a leading scientist in this field who supervised the studies, stated, �Our studies have indicated robust disease suppressing activity for CGEN-15001 in the SJL R-EAE model, a recognized mouse model for multiple sclerosis. These studies have also demonstrated that CGEN-15001 has the unique ability to inhibit proliferation, differentiation, and cytokine production of pro-inflammatory Th1 and Th17 responses while at the same time sparing or actually promoting regulatory Th2-derived cytokines. As far as I am aware, this potentially very beneficial pattern of inhibiting Th1/Th17 while promoting Th2 responses is unique among the reagents targeting the B7 family of co-stimulatory molecules that have been published to date.� Compugen�s VP R&D, Dr. Zurit Levine stated, �We are extremely pleased by this further demonstration of the unique discovery capability that has been created at Compugen. In view of its recognized potential in the largely unmet and critical field of immune regulation, the B7/CD28 co-stimulation protein family has been an area of extensive research for a number of years. In our opinion, in addition to providing Compugen with a very attractive product candidate, the predictive discovery and experimental validation of a previously unknown member of this extensively researched protein family represents a major milestone in the transition from experimentally based therapeutic discovery to in silico prediction and selection.� Source: Compugen Ltd. (03/02/10)

The rising prevalence and changing age distribution of multiple sclerosis in Manitoba

Wed, 03 Feb 2010 04:11:00 EST

Summary Several studies suggest an increasing prevalence of multiple sclerosis (MS) in Canada. Canadian MS neurologist and researcher Dr. Marrie and colleagues aimed to validate a case definition for MS using administrative health insurance data, and to describe the incidence and prevalence of MS in Manitoba, Canada. Neurology. 2010 Jan 13. [Epub ahead of print] Details Provincial administrative claims data were reviewed to identify persons with demyelinating disease using International Classification of Diseases 9/10 codes and prescription claims. Questionnaires were mailed to 2,000 randomly selected persons with an encounter for demyelinating disease, requesting permission for medical records review. Diagnoses abstracted from medical records were used as the gold standard to evaluate candidate case definitions using administrative data. From 1984 to 1997, cases of MS using claims data were defined as persons with seven or more medical contacts for MS. From 1998 onward, cases were defined as persons with three or more medical contacts. As compared to medical records, this definition had a positive predictive value of 80.5% and negative predictive value of 75.5%. From 1998 to 2006, the average age- and sex-adjusted annual incidence of MS per 100,000 population was 11.4 (95% confidence interval [CI] 10.7-12.0). The age-adjusted prevalence of MS per 100,000 population increased from 32.6 (95% CI 29.4-35.8) in 1984 to 226.7 (95% CI 218.1-235.3) in 2006, with the peak prevalence shifting to older age groups. Authors conclude that the prevalence of multiple sclerosis (MS) in Manitoba is among the highest in the world. The rising prevalence with minimally changing incidence suggests improving survival. This study supports the use of administrative data to develop case definitions and further define the epidemiology of MS. Source: MS Society of Canada National Research and Programs (03/02/10)

Pregnancy changes the expression of inflammation-related genes in patients with Multiple Sclerosis

Wed, 03 Feb 2010 03:59:00 EST

Pregnancy is associated with reduced activity of multiple sclerosis (MS). However, the biological mechanisms underlying this pregnancy-related decrease in disease activity are poorly understood. We conducted a genome-wide transcription analysis in peripheral blood mononuclear cells (PBMCs) from 12 women (7 MS patients and 5 healthy controls) followed during their pregnancy. Samples were obtained before, during (i.e. at the third, sixth, and ninth month of gestation) and after pregnancy. A validation of the expression profiles has been conducted by using the same samples and an independent group of 25 MS patients and 11 healthy controls. Finally, considering the total group of 32 MS patients, we compared expression profiles of patients relapsing during pregnancy (n = 6) with those of relapse-free patients (n = 26). Results showed an altered expression of 347 transcripts in non-pregnant MS patients with respect to non-pregnant healthy controls. Complementary changes in expression, occurring during pregnancy, reverted the previous imbalance particularly for seven inflammation-related transcripts, i.e. SOCS2, TNFAIP3, NR4A2, CXCR4, POLR2J, FAM49B, and STAG3L1. Longitudinal analysis showed that the overall deregulation of gene expression reverted to �normal� already within the third month of gestation, while in the post-partum gene expressions rebounded to pre-pregnancy levels. Six (18.7%) of the 32 MS patients had a relapse during pregnancy, mostly in the first trimester. The latter showed delayed expression profiles when compared to relapse-free patients: in these patients expression imbalance was reverted later in the pregnancy, i.e. at sixth month. Specific changes in expression during pregnancy were associated with a decrease in disease activity assessed by occurrence of relapses during pregnancy. Findings might help in understanding the pathogenesis of MS and may provide basis for the development of novel therapeutic strategies. Francesca Gilli1*, Raija L. P. Lindberg2, Paola Valentino1, Fabiana Marnetto1, Simona Malucchi1, Arianna Sala1, Marco Capobianco1, Alessia di Sapio1, Francesca Sperli1, Ludwig Kappos2, Raffaele A. Calogero3, Antonio Bertolotto1 1 Regional Centre for Multiple Sclerosis (CReSM) and Clinical Neurobiology, Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, Italy, 2 Departments of Biomedicine and Neurology, University Hospital Basel, Basel, Switzerland, 3 Genomics and Bioinformatics Unit, Department of Clinical and Biological Sciences, Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, Italy Full Paper - http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008962 Source: PLoS ONE � 2010 Gilli et al. (02/02/10)

UBC researchers planning to study Multiple Sclerosis vein theory

Sat, 30 Jan 2010 05:06:00 EST

A medical centre in British Columbia says it wants to become the first in the country to test the controversial theory that multiple sclerosis patients have blocked veins, preventing proper blood flow from the brain. "There's a large demand for us to look into this," Dr. Anthony Traboulsee told CTV News. "Patients are very excited. We are very interested ourselves, and we want to meet the demand of our patients." A group of researchers at the University of British Columbia MS Clinic, part of the Vancouver Coastal Health Authority, are planning to study the theory, using a variety of imaging techniques. If it gets approval and funding, it appears to be the most comprehensive examination of this novel theory in the world. They will be studying the findings of Italian researcher Dr. Paolo Zamboni, who believes that blocked veins in the neck and chest of MS patients lead to blood drainage problems and triggers the immune responses that mark the disease. Zamboni contends that angioplasty surgery on these blocked veins, a procedure he calls the Liberation Treatment, can then open them. A preliminary study of the treatment in 65 patients showed it improved the quality of life for many patients, and as long as the veins remained open, symptoms of MS were reduced and new attacks were halted. The BC team envisions a study that begins with MS patients being scanned for abnormalities, likely using the ultrasound test pioneered in Italy. They would also be given MRI scans, to see how the different tests detect possible problems. The prevalence of vein problems would also be assessed in MS patients and in normal healthy control patients. Data would also be blinded to minimize the risk for bias in the research. Once these non-invasive scans have been done, test patients would proceed to the angiography suite. There they would undergo a venogram. That's where a probe is inserted, from the groin, into the vein system that travels through the chest and into the neck. Doctors inject a dye and watch the blood-flow. This is also, according the University of Ferrara team, the definitive way of seeing blockages in the jugular veins in the neck and the azygos vein in the chest. And if there are blocked or narrowed veins, the UBC researchers want to open them up to see what happens. "Not only do we want to see if we can detect these abnormalities, we also want to see, if we change them, does it improve peoples' lives?" said Traboulsee. The B.C. researchers, who include radiologists, vascular specialists, and physicists working on new imaging technologies, say they had heard about the theory before CTV's W5 aired a story describing the theory, and were investigating the possibility of a study. But interest in the theory in Canada has exploded since the episode aired. A professor of neurosurgery at the University of Buffalo, Dr. Robert Zivadinov, who worked on an early study with Zamboni, says his office was contacted by 8,000 MS patients in the three weeks after the W5 episode aired. The Vancouver researchers want to determine the prevalence of the vein abnormality, which Zamboni has dubbed CCSVI -- or chronic cerebrospinal venous insufficiency. They also want to know how easily it can be detected with ultrasound and MRI testing. Joining the study will be Alex Rauscher, a physicist. He hopes to look at MRI scans of patients to search for evidence of iron deposits in the brain, since some research has suggested that iron in the brain may contribute to the inflammation and the immune system attacks that mark MS. "It is our duty to find the answers," said Rauscher. The Vancouver Coastal Health researchers say they have applied for funding from the MS Society of Canada to fund research to determine the most practical and reliable test for CCSVI. But because of the size and scope of the study -- and their desire to begin quickly -- they are also accepting funding from other agencies and private donations. Donations should be directed to: VGH and UBC Hospital Foundation , UBC Faculty of Medicine (funds can be specified for CCSVI research) The researchers note that their study is not accepting patients yet and likely won't for a few months until they acquire funding, obtain ethical approval, and develop an MRI and ultrasound testing protocol. Patients are asked to refrain from contacting the clinics until they are ready to proceed with the study. Meanwhile in Italy, one of the companies that manufactures the ultrasound machines used in the testing for CCSVI, is beginning to hold training sessions for doctors and technicians who want to learn the novel technique for scanning the neck and head. One training program is being held this week at the University of Ferrara with technicians who developed the tests, and with Zamboni. A second session is planned for March. Contact information for the course is available through: Claudio.Buffagni@esaote.com Source: CTV News � 2010 CTV Globe Media (30/01/10)

Australian study questions established concepts of early disease events in MS

Sat, 30 Jan 2010 03:00:00 EST

Investigators at the University of Sydney have published a study suggesting that the earliest activity seen in the brain in MS is the destruction of cells that make myelin (oligodendrocytes), occurring before the onset of immune activity usually blamed for triggering the disease. This provocative study, co-funded by many sources including the National MS Society, opens up new possibilities for finding the cause of the disease and developing new treatments. The study is authored by Drs. John W. Prineas, Andrew P.D. Henderson and colleagues, and is published in the December issue of Annals of Neurology (2009;66:739�753). Background: Multiple sclerosis has long been thought to be triggered by immune attacks in the brain and spinal cord, causing a spectrum of neurological symptoms. Extensive research has been underway to better understand what triggers the immune attacks and which immune cells are involved, and to better understand the damage to the central nervous system that occurs during the course of MS. In addition to studies of immune activity underlying what has been considered an autoimmune process, another important approach has centered on pathology studies involving microscopic explorations of MS lesions (damaged areas, also called plaques) in the brains of people with MS. The lead author of the current study, John W. Prineas, MB, BS, FRCP, was the 2001 winner of the John Dystel Prize for MS Research, an award given jointly by the National MS Society and the American Academy of Neurology. He was recognized for being the investigator who first described how myelin, the substance that insulates nerve fibers, is broken down in MS, and he was the first to demonstrate that myelin repair occurs during the course of MS through the body�s natural repair processes. Current Study: For this study, the team used brain specimens from 11 people who had died early in the course of their MS, and the team also used comparison specimens from people with other disorders including stroke. Some of the tests focused on subsets of specimens from seven people who had lesions showing active myelin destruction. To get a sense of immune cell activity in the brain and at what stage it was occurring, the team examined newly active and resolved lesions, as well as nearby blood vessels, surrounding areas showing some disease activity and surrounding areas that appeared normal, and areas that were farther away from the lesions of interest. Results: In tissues surrounding newly forming lesions, the investigators found evidence of the loss of oligodendrocytes with an absence of immune T or B cells that would normally be held responsible for launching the immune attack against oligodendrocytes and the myelin they produce. These and other immune cells, including scavenger cells (macrophages and microglia), were more numerous in lesions and surrounding tissues at apparently later stages of destruction and sometimes in lesions that were in the process of repair. In specimens from two very early cases of clinical onset of disease, they found few immune cells within the lesions and no evidence of activation of scavenger cells. These and other unexpected findings from this study led the investigators to propose that the early immune activity seen in active lesions is that of macrophages and microglia, whose job it is to clean up and remove damaged myelin. They propose that lesion formation is caused by something other than destructive immune activity led by inflammatory cells against a component of myelin or oligodendrocytes. Comment: This study is a significant addition to a small but growing body of evidence that highlights the question of what triggers MS and whether there is something other than, or in addition to, the immune attacks that lead to tissue damage in the brain and spinal cord of people with MS. Further research, which is ongoing by investigators around the world, should shed further light on this question and may offer novel treatment approaches. Note: The availability of donor brain specimens was crucial to this and other studies focusing on disease pathology Source: US National Multiple Sclerosis Society (30/01/10)

Could stem cells reverse Multiple Sclerosis?

Fri, 29 Jan 2010 02:31:00 EST

Biologist Tom Lane and a team of UCI researchers are leading an effort to determine whether a stem-cell-based treatment can repair neurological damage caused by multiple sclerosis. More than eight years ago, Tom Lane helped discover a potential way to prevent multiple sclerosis from affecting the central nervous system. Now he�s leading an effort at UC Irvine to determine whether a stem-cell-based treatment can repair neurological damage caused by the chronic disease. Lane, a molecular biology & biochemistry professor, is among 15 U.S. researchers who recently received five-year Collaborative MS Research Center Awards from the National Multiple Sclerosis Society. With the $742,500 in funding, he has assembled a team to investigate the use of cell-replacement therapy to regenerate MS-ravaged nerve tissue. In people with MS, immune-system T cells attack myelin, the protective coating of nerves, and eventually the nerve fibers themselves. Symptoms may be mild, such as intermittent numbness in the limbs, or severe, such as paralysis or loss of vision. There is no cure for MS, and current treatments mainly try to limit immune-system response. �The promise of cell-replacement strategies to treat MS is significant,� Lane says. �Imagine being able to infuse people with cells that could make new myelin or transform into healthy nerve cells. That�s the focus of our effort.� Spinal cord injury research at UCI has already shown the potential of cell-replacement therapy to repair myelin. Neurobiologist Hans Keirstead pioneered a technique to turn human embryonic stem cells into myelin-making oligodendrocyte precursor cells (OPCs) that, he demonstrated, can restore impaired nerve function. These findings form the basis of an upcoming clinical trial involving people with acute spinal cord injury. With Keirstead providing the cell lines, the UCI team will explore OPCs� ability to repair MS-related myelin damage and how the cells could be safely introduced into the body. Researchers and their topics include: � Lane studying immune-system messenger cells called chemokines that permit the migration of OPCs to their targeted nerve sites. � Dr. George Chandy, physiology & biophysics professor, investigating methods of muting T cell response while OPCs reconstruct myelin. � Michael Cahalan, physiology & biophysics professor and chair, developing ways to track and visualize the migration of stem cells and immune cells within the living central nervous system. � Dr. Michael Demetriou, associate professor of neurology and director of the comprehensive MS program at UC Irvine Medical Center, examining how enzymes direct T cells and, possibly, OPCs. � Dr. Steven Schreiber, neurology professor and interim chair, determining whether niacin can increase the repair capacity of OPCs. �With the knowledge acquired from these studies, we believe we�ll lay the foundation for the creation of safe and effective treatments to improve quality of life for people with MS,� Lane says. �UCI has long been a leader in MS research and patient care, and it�s exciting to be part of the significant impact our researchers and clinicians make in this field.� Source: Physorg.com � PhysOrg.com 2003-2009 (29/01/10)

MRI study evaluates dynamic causal model to assess interactions of brain regions during motor task in Multiple Sclerosis patients

Fri, 29 Jan 2010 01:52:00 EST

The use of functional MRI to assess patterns of brain activation in adults and children with multiple sclerosis (MS) may offer insight into disease progression among these groups, according to research published in the February issue of Radiology. Maria A. Rocca, M.D., of the University Hospital San Raffaele in Milan, Italy, and colleagues analyzed data from five small groups: healthy pediatric and adult controls, pediatric and adult patients with relapsing-remitting MS, and adults with clinically isolated syndromes. Patients underwent MRI during a simple motor task. Also, a dynamic causal model approach was used to assess interactions between different regions during the task. The researcher's findings suggest that the brain pattern of cortical activation is relatively preserved in pediatric relapsing-remitting patients, and additional areas of the network are progressively recruited in adult relapsing-remitting patients. The relatively preserved adaptive properties of the cerebral cortex in pediatric patients may inhibit clinical disability in the short to medium term. "The preservation of brain adaptive properties might explain the favorable medium-term clinical outcome of pediatric MS patients," the authors write. "The progressive recruitment of cortical networks over time in patients with the adult relapsing-remitting forms of the disease might result in a loss of their plastic reservoir, thus possibly contributing to subsequent disease evolution." Abstract Source: Modern Medicine � 2010 HealthDay. (29/01/10)

Skin cells turned directly into neurons

Fri, 29 Jan 2010 01:17:00 EST

Stem cell scientists at Stanford University in California announced "a huge step forward", with the publication of research that turned skin into nerve cells without any intermediate step. The production of neurons [nerve cells] directly from other adult cells, without making stem cells en route, could transform "regenerative medicine" - providing a plentiful supply of neurons for treating people with degenerative brain diseases such as Parkinson's or those with spinal injuries. "We actively and directly induced one cell type to become a completely different cell type," said Marius Wernig of Stanford's Institute for Stem Cell Biology and Regenerative Medicine. "These are fully functional neurons. They can do all the principal things that neurons in the brain do." This includes making connections with and signalling to other nerve cells - critical functions if the cells are eventually to be used as therapy for brain disease. The study is published online in the journal Nature . Although research had suggested that specialised cells could be coaxed to show properties of other cell types, this is the first time skin cells have been converted into neurons in a laboratory. The change happened within a week of treating mouse skin cells with a mixture of three genes, with an efficiency of up to nearly 20 per cent. The scientists are now working to duplicate the feat with human cells. Until recently, scientists believed cellular differentiation was a one-way process, with primitive and versatile embryonic stem cells giving rise to all the body's more specialised cells. Then, in 2007 they discovered how to turn the clock back, reversing the specialisation process by converting adult cells to "induced pluripotent stem cells", which could then become a different type of cell. The latest discovery shows that this intermediate step is unnecessary. But many years of work will be needed before direct conversion reaches the clinic. Source: The Financial Times Copyright The Financial Times Limited 2010. (29/01/10)

Biogen starts human trial of drug that could repair Multiple Sclerosis damage

Wed, 27 Jan 2010 11:30:00 EST

Biogen Idec Inc. has begin human testing of an experimental drug, dubbed BIIB033, that it hopes will take the revolutionary step of repairing some of the damage done by multiple sclerosis. Although it is a major step to begin testing in humans, drug development is always risky and it will take years to measure the drug's effectiveness and potential side effects. Multiple sclerosis, or MS, is a chronic, inflammatory condition that occurs when the body attacks its own myelin, the protective insulation surrounding the nerve fibers, or axons, in the central nervous system. The debilitating disease affects an estimated 400,000 people in the U.S., according to the National MS Society, but current treatments only aim to slow the disease's progression and cannot help repair damage. Research that focuses on ways to help the body regenerate myelin is growing and scientists around the world are taking several different approaches. Damage to myelin can distort or block messages carried by axons and result in a wide variety of MS symptoms such as vision problems, limb numbness and paralysis. BIIB033 is an antibody designed to turn off Lingo-1, a molecule that the company believes prevents myelin production in adults after axons are well covered. Blocking Lingo-1 may encourage myelin regeneration, something that occurs in healthy adults, after damage from MS occurs. The antibody has been shown to be effective in mouse models that are accepted as being useful for mimicking the properties of MS. The small Phase I study will include 64 healthy volunteer adults in the Netherlands, with the main goal of assessing safety and tolerability, and is expected to be completed in 2011. The placebo-contolled study will give patients a single dose of the drug and different groups will get different amounts, a standard practice in such early trials that helps determine the optimal dose for later investigation. The secondary goals of the trial relate to how the body processes the drug and there is no measure of its effectiveness, which is not surprising in such an early study that doesn't actually include MS patients. MS is an attractive area of drug makers as its often requires lifelong treatment, and MS drugs brought in more than $8.7 billion in 2009 revenue worldwide, according to projections from Bernstein Research. Biogen is mostly focused on selling MS treatments, including Tysabri and Avonex, which are expected to bring sales of more than $3 billion for 2009. Source: Dow Jones Newswires (c) 2010 Dow Jones & Company, Inc. (27/01/10)

More checks for Multiple Sclerosis drug Tysabri

Wed, 27 Jan 2010 02:16:00 EST

Last week, the European Medicines Agency (EMEA) finalized a review of Biogen Idec�s Tysabri (natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML) associated with the prolonged use of the drug. PML is a rare brain infection caused by the JC virus. The agency�s Committee for Medicinal Products for Human Use (CHMP) arrived at the conclusion that the risk of a patient developing PML increases after having taken the drug for two years or more, though the risk remains low. However, the benefits of the drug outweigh its risks. Given the importance of the early detection of PML, the committee has recommended certain measures to ensure that patients and doctors are aware of the associated risks. Measures include updating product information to include the high risk of developing PML after two years of treatment and advice regarding management of patients showing symptoms of PML. In addition, the committee suggested that forms should be signed by patients at the beginning and after two years of treatment after having discussed the risks with their doctors. The CHMP had to review the drug after 23 confirmed cases of PML were reported between July 2008 and October 2009, causing four deaths. Fourteen of these cases including one death were reported in the EU. Subsequently, the European Commission in October 2009 requested CHMP�s opinion for Tysabri. As of January 20, 2010, the total number of PML cases has risen to 31, of which 23 were patients who had been receiving the drug for more than two years. This is equivalent to approximately one case of PML for every 1,000 patients treated with Tysabri for two years or more, consistent with the risk mentioned in the Tysabri�s label. Tysabri, meant for the treatment of multiple sclerosis (MS) is jointly marketed with Elan Corp. The drug was withdrawn from the U.S. market in 2005 due to the PML concern, but was launched again after one year with a strict warning regarding the occurrence of PML. Source: Yahoo! Finance � 2010 Yahoo! (27/01/10)

Tysabri PML updates set to start again

Tue, 26 Jan 2010 03:27:00 EST

The maker of Tysabri will once again provide monthly updates regarding new cases of progressive multifocal leukoencephalopathy, or PML, an often fatal brain infection seen in some people treated with the multiple sclerosis (MS) drug. Biogen Idec Inc. had stopped providing the monthly PML updates last summer. Tysabri is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options. Unfortunately, it also poses serious risks because of its association with PML. PML attacks the brain and central nervous system and is usually fatal. It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the drug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing MS or Crohn�s Disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. In September, the U.S. Food & Drug Administration (FDA) revealed that 24 cases of PML had been reported in Tysabri users, more than double the 11 Biogen Idec had disclosed at its final monthly update in July. As of mid-January, the number of PML cases among people treated with Tysabri stands at 31. According to The Wall Street Journal, through the new Tysabri monitoring program, Biogen Idec will update physicians about new PML cases at the middle of each month. Doctors will be able to access this information through a password-protected Web site. In addition to the number of PML cases, Biogen Idec will provide details on duration of use, as well as a cumulative patient exposure figure. Investors will be able to access the same information via Investor Relations. According to the Journal, no public Web site will be launched to provide the information. Tysabri patients can request the information, but the information they will be provided will not be as detailed as what doctors, or even investors, are give. The disparity is the result of regulations that restrict direct interactions between patients and drug companies. Source: newsinferno.com � 2009 NEWSINFERNO.COM (26/01/10)

Drugs may shut down several Epstein-Barr virus-induced diseases - possibilities for MS?

Tue, 26 Jan 2010 02:13:00 EST

The same virus that causes relatively mild mononucleosis, the "kissing disease," can also cause severe mono as well as several potentially deadly kinds of cancer. Now researchers think they can kiss a stealthy form of Epstein-Barr virus (EBV) goodbye - or at least shut it down enough to successfully treat several of the dangerous diseases it causes. Using a class of drugs being clinically tested to treat other kinds of cancer, researchers at the University of Wisconsin School of Medicine and Public Health found that the drugs were the first to stop the latent form of EBV infection from causing disease. The drugs, Hsp90 inhibitors, prevented human EBV-related tumors from growing in mice, protected immune cells from transforming into tumors and killed established tumor cells at low, non-toxic doses. Until now, there have been no effective drugs for treating latent EBV infection in any of the EBV-associated diseases, which in addition to mono include a subset of stomach cancers, certain types of nose-throat cancer and lymph node cancers such as lymphoproliferative disease, says lead author Shannon C. Kenney, MD. "This discovery suggests a new way of treating patients with severe mononucleosis, which in rare circumstances can be fatal, and patients with EBV-driven cancers, particularly immuno-compromised AIDS and transplant patients," says Kenney, an infectious disease expert at UW Hospital and Clinics. The study appears in the current (Jan. 25, 2010) Proceedings of the National Academy of Sciences. Kenney, also a professor of oncology at the McArdle Laboratory for Cancer Research and of medicine, has studied EBV for nearly 30 years. Most of her work has focused on the form of EBV that actively produces infection, but recently she turned to the so-called latent form. "The latent infection form actually is not so latent," says Kenney, a member of the UW Carbone Cancer Center. "This is the form of EBV that is most closely associated with cancer development." Latently infected cells express transforming viral proteins that can change normal cells into cancer cells. One key viral protein, EBNA-1, is required for EBV to live long-term in host cells. Many scientists and drug companies are looking for ways to block this viral protein, expressed in every EBV-infected cell. Kenney and her team had been using Hsp90 (heat shock protein 90) inhibitors as they studied the infectious form of EBV. "Normal cells can survive when treated with Hsp90 inhibitors," Kenney says. "In contrast, Hsp90 inhibitors are toxic to certain types of cancer cells, which often are more dependent upon high levels of Hsp90." After they discovered that EBNA-1 itself must have Hsp90 in order to function in cells, the Wisconsin researchers conducted three different experiments to see what the effect of exposing EBV-infected cells to Hsp90 inhibitors would be. In all three experiments, the results showed a dramatic reduction in EBNA-1-related activity. The drugs killed EBV-induced tumor cells in one experiment, halted the growth of EBV-induced tumors in mice in another and protected normal immune cells from becoming transformed to tumor cells in the third. And while the drugs were highly toxic to EBV-infected cells, they had very little effect on normal cells at the doses used in the experiments. The researchers found the underlying explanation to be that EBNA-1 could not be processed - synthesized and translated - to any degree when Hsp90 inhibitors were present. Kenney expects the inhibitors-geldanamycin, 17-AAG and 17-DMAG-may be useful for most but not all kinds of EBV-induced cancers as well as severe mono. In fact, the drugs may be even more widely useful, says Kenney, because clinicians are seeing that people older than age 70 are getting certain forms of EBV-induced cancers more frequently. "There also is tantalizing early evidence that EBV may contribute to auto-immune diseases such as lupus and multiple sclerosis," she says. And what about the possibilities for standard mono? "The majority of healthy humans will get over mono with no treatment after a month or two," says Kenney. "But Hsp90 inhibitors could potentially help, in terms of getting people back to school or work sooner. Clinical trials will need to be performed in patients to determine if these drugs are useful in severe mononucleosis." Source: PhysOrg.com � PhysOrg.com 2003-2009 (26/01/10)

PROLOR Biotech reports positive results from comparative study of its longer-acting version of Multiple Sclerosis drug Interferon Beta in primates

Mon, 25 Jan 2010 11:06:00 EST

PROLOR Biotech, Inc., today reported positive results from a comparative study in primates of its longer-acting version of the multiple sclerosis drug interferon beta (IFN-beta-1a-CTP, referred to as IFN-beta-CTP). The study was designed to measure the potential increase in durability (half-life), overall drug exposure (AUC) and biological potency of PROLOR's long-acting CTP-modified human interferon beta when compared with commercially available interferon beta. Interferon-beta-1a (referred to as IFN-beta), which is indicated for the treatment of multiple sclerosis (MS), is currently marketed by Merck Serono as Rebif� and by Biogen Idec as Avonex�, with combined annual sales estimated at more than $3 billion worldwide. The study results show that PROLOR's CTP-modified IFN-beta, when compared with commercially available recombinant IFN-beta, showed 13 times prolonged durability (half-life), and 55 times prolonged overall drug exposure (AUC) in primates. IFN-beta-CTP also demonstrated strong biological potency as measured by several well-validated biomarkers including anti-viral activity and changes in neopterin, and 2'-5' oligo A synthesase. The expanded biological potency seen in this new study is consistent with the results of a previous study in mice conducted by PROLOR, which compared the anti-tumor activity of IFN-beta-CTP to commercially available IFN-beta in a model of human cancer. In that study, IFN-beta-CTP showed 100% inhibition of human melanoma tumors implanted in nude mice after eight days and 87.5% inhibition after 10 days, versus 50% inhibition with commercially available IFN-beta after eight days and just 12.5% inhibition after 10 days. "The results of this new primate study, together with the strong biological activity seen in our melanoma tumor growth model, further confirm the clinical potential for IFN-beta-CTP as a long-acting version for the treatment of multiple sclerosis, with the potential to provide important benefits to MS patients," said Dr. Abraham Havron, CEO of PROLOR Biotech. "Many MS patients currently rely on IFN-beta to keep their disease in check, but to do so they must inject the drug frequently, with the attendant risk of adverse reactions that often accompany these injections. By potentially allowing these patients to dramatically reduce the required injection frequency, we believe our IFN-beta-CTP could significantly enhance their quality of life." Source: PROLOR Biotech, Inc. (25/01/10)

FDA clears Acorda drug, Ampyra, for improved walking in Multiple Sclerosis

Sat, 23 Jan 2010 07:05:00 EST

Federal health regulators have approved an Acorda Therapeutics pill to improve walking in patients multiple sclerosis, an often disabling disease that affects the nervous system. The Food and Drug Administration said Friday Ampyra is the first drug approved to help multiple sclerosis patients walk. About 400,000 patients in the U.S. have the disease, which affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems. Between 260,000 and 340,000 of those patients have difficulty walking, and could be eligible for the new drug, according to company officials. Acorda, based in Hawthorne, N.Y., conducted two trials tracking patients' ability to complete a 25-foot walking exercise. Both studies showed improvements in time needed to complete the exercise. While those gains were often just a fraction of a second, Acorda CEO Ron Cohen said that on average, patients' times improved by 25 percent after taking Ampyra. Cohen said the company will launch Ampyra in the U.S. in March. He added that the pill could be combined with older medications designed to slow the progression of multiple sclerosis. Ampyra will be manufactured under a license with Irish drugmaker Elan Corp., which developed the extended-release formulation for the pill. Acorda will market and distribute the drug in the U.S. Company shares jumped $2.50, or 9.8 percent, to close at $28.12 Friday, adding 13 cents in after-hours trading. In its announcement posted online, the FDA warned that Ampyra can cause seizures when given at higher-than-recommended doses � anything over 10 mg. Company studies showed that doses above 10 mg increased seizure risk but did not increase the drug's effectiveness. The FDA said the drug should also not be given to patients with moderate to severe kidney disease, as they are at greater risk of seizures. Other side effects reported in clinical trials included: insomnia, urinary tract infections, dizziness, headache, nausea and throat pain, according to the FDA. Source: ABC News Copywrite ABC News.com 2010 (23/01/10)

European Medicines Agency issues recommendations following review of Tysabri and PML risk

Fri, 22 Jan 2010 02:37:00 EST

The European Medicines Agency has finalised a review of Tysabri (natalizumab) and the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by the JC virus. The Agency�s Committee for Medicinal Products for Human Use (CHMP) has concluded that the risk of developing PML increases after two years of use of Tysabri although this risk remains low. However, the benefits of the medicine continue to outweigh its risks for patients with highly active relapsing-remitting multiple sclerosis, for whom there are few treatment options available. Because it is important that PML is detected early, the Committee recommended that a number of measures be put in place to ensure that patients and doctors are fully aware of the risks of PML. These include: * An update of the product information to add information about the increase in the risk of PML after two years of treatment and additional advice on how to manage patients who show signs of PML; * Forms to be signed by patients at the beginning of treatment with Tysabri, and again after two years of treatment, after in-depth discussions about the risk of PML with their doctor. Measures to minimise the risk of PML were part of the initial marketing authorisation for Tysabri, issued in June 2006. Since then, they have been continuously updated and strengthened to increase awareness of the risk of PML. The new measures are designed to complement the existing recommendations that patients, and their carers, partners and families should be made aware of the symptoms of PML and that patients should be closely monitored throughout treatment. Source: EMA (22/01/10)

BTG commences phase IIa study of Pleneva for Multiple Sclerosis

Thu, 21 Jan 2010 06:58:00 EST

BTG Plc said it commenced dosing in a European multicentre Phase IIa study of Pleneva, a novel orally administered compound under development as a potential treatment for multiple sclerosis. According to the company, the study, in 166 patients with the relapsing-remitting form of the disease, comprises an initial 24 week double-blind, placebo-controlled dosing period followed by a 24 week open-label extension. The primary endpoint of the study is a reduction in the number of new T1 gadolinium enhanced lesions on MRI at weeks 12, 16, 20 and 24 when compared to placebo. Source: RTT News � 2010 RTTNews (21/01/10)

Rewiring the brain with stem cells

Thu, 21 Jan 2010 06:24:00 EST

New research finds that in mice, transplanted neurons grown from embryonic stem cells can form proper connections with other brain parts. Writing in The Journal of Neuroscience, researchers described an experiment in which they successfully grew neurons from stem cells in Petri dishes, then transplanted those neurons into the brains of young mice. James Weimann, one of the authors of the study, said that the work was a hopeful sign for stem cell based treatments on the horizon. "These stem cell-derived neurons can grow nerve fibers between the brain�s cerebral cortex and the spinal cord, so this study confirms the use of stem cells for therapeutic goals," he said. However, the researchers cautioned that this work was so far only performed in young mice, and it remained to be seen whether the approach would work in older mice or in other animals. Source: Science Friday Copywrite ScienceFriday Inc. (21/01/10)

Biogen optimistic on Tysabri despite 3 new PML cases

Thu, 21 Jan 2010 06:01:00 EST

Biogen Idec officials said Wednesday three more patients have contracted a rare brain infection associated with the company�s multiple sclerosis drug, Tysabri. However, the Cambridge-based biotechnology company says the additional cases do not impact the overall safety profile for the medication. The total number of cases of progressive multifocal leukoencephalopathy, or PML, since July 2008 now stands at 31. More than 60,000 patients have taken Tysabri since the drug�s reintroduction in July 2006, and the incidence of PML is currently .47 cases per 1,000 patients. Tysabri�s warning labels said the anticipated incidence rate of PML is 1 in 1,000 rate. The company took Tysabri off the market between February 2005 and July 2006 because of concerns about the risk of PML. Since the risks of contracting PML increases the longer a patient takes the drug, the number of PML cases is expected to rise. So far, 19 cases have been detected in Europe, 10 cases in the United States. Two other cases have been detected elsewhere, according to Biogen officials. Source: Boston Business Journal � 2010 American City Business Journals, Inc (21/01/10)

New oral drug Cladribine for Multiple Sclerosis shows promise

Thu, 21 Jan 2010 05:33:00 EST

A major trial of the oral drug Cladribine � results of which are published in the New England Journal of Medicine on 20 January 2010 � has shown that it significantly reduces relapse and deterioration of the disease, and goes a long way to eliminating the unpleasant side effects associated with existing therapies. Cladribine is vying to be the first ever treatment in tablet form for MS, and only needs be taken for between 8 to 10 days a year, eliminating the need for regular injections and intravenous infusions otherwise endured by sufferers. The ease with which Cladribine tablets can be administered, combined with its relatively few side effects, make it a hugely exciting development in the world of MS. Multiple sclerosis is a disabling neurological condition which usually starts in young adulthood. It results from the body's own immune system damaging the central nervous system. This interferes with the transmission of messages between the brain and other parts of the body and leads to problems with vision, muscle control, hearing and memory. Cladribine tablets work by suppressing the immune system thus compromising its ability to further attack the central nervous system. Led by Professor Gavin Giovanonni at Barts and The London School of Medicine and Dentistry, the new study involved over 1,300 MS patients who were followed up for nearly two years and monitored using MRI scans. Patients were given either two or four short treatment courses of Cladribine tablets per year, or a placebo. Each course consists of one or two tablets per day for four or five days, adding up to just eight to 20 days of treatment each year. Compared to patients who were taking a placebo, those taking Cladribine tablets were over 55 per cent less likely to suffer relapse, and 30 per cent less likely to suffer worsening in their disability due to MS. Professor Giovanonni said: "The introduction of an oral therapy, particularly one that has no short term side effects and is as easy to use as oral Cladribine, will have a major impact on the treatment of MS. "However, the use of this drug as a first line therapy will have to be weighed up against the potential long term risks which have yet to be defined." Source: Queen Mary, University of London � Disabled World 2010 (21/01/10)

Low Vitamin D levels are associated with greater risk of MS relapse

Thu, 21 Jan 2010 04:25:00 EST

Low vitamin D blood levels are associated with a significantly higher risk of relapse attacks in patients with multiple sclerosis (MS) who develop the disease during childhood, according to a study conducted by researchers from the University of California, San Francisco. �We have known for some time that vitamin D insufficiency is a risk factor for developing MS, but this is the first study to assess whether vitamin D levels influence the disease course of those who already have MS,� said lead author Ellen Mowry, MD, MCR, a clinical instructor of neurology at the UCSF Multiple Sclerosis Center. The study, which is now published online by the �Annals of Neurology� and is available at http://www3.interscience.wiley.com/journal/123246501/abstract , demonstrates that an increase in vitamin D levels by 10 nanograms per milliliter of blood (ng/mL) corresponds with a 34 percent decrease in the rate of subsequent relapses. In other words, raising the vitamin D level of a person with MS by 15 ng/mL, which requires about 2,000 international units of vitamin D supplementation a day, could theoretically cut a patient�s relapse rate in half, explained Mowry. �Although we do not yet know if vitamin D supplementation will be beneficial for MS patients, the fact that there is a clear association between vitamin D levels and relapse rate provides strong rationale for conducting a clinical trial to measure the potential impact of supplementation,� she said. �This is an exciting finding because it indicates that it is very possible for vitamin D supplementation to have a profound impact on the course of this disease,� said senior author Emmanuelle Waubant, MD, PhD, an associate professor of neurology at UCSF and director of the Regional Pediatric MS Center at UCSF Children�s Hospital. Waubant said she expects similar findings in adult patients with MS. Multiple sclerosis is a chronic and often disabling disease that affects the central nervous system, which comprises the brain, spinal cord and optic nerves. A type of autoimmune disorder, MS causes the body�s own defense system to break down a substance called myelin, which surrounds and protects nerve fibers. Although MS occurs most commonly in adults, a small proportion of cases are diagnosed in children and adolescents. According to the National MS Society, two to five percent of all people with MS experience their first symptoms before the age of 18. The researchers measured vitamin D levels through blood samples from 110 patients whose MS symptoms began at age 18 or younger. The patients were seen at either UCSF Children�s Hospital or the State University of New York Stony Brook�s Regional Pediatric MS Center of Excellence � two of six multidisciplinary referral centers in the United States sponsored by the National MS Society. After providing the initial blood sample, patients were followed for an average of 1.7 years, during which the researchers recorded the total number of relapses each patient experienced. According to Mowry, a relapse or flare-up of MS causes new neurologic symptoms or the worsening of old ones, such as impaired vision, problems with balance, or numbness. Relapses can be very mild or severe enough to interfere with a person�s ability to function. During the follow-up period, the researchers assessed the patients� relapse rates and vitamin D levels after controlling for such factors as age, gender, race, ethnicity, use of MS treatments and the duration of follow-up care. �If we are able to confirm that vitamin D supplementation is an effective treatment, my hope is that it will help improve the quality of life for all MS patients,� Mowry said. In addition to a randomized clinical trial of vitamin D supplementation in MS patients, Mowry said further studies are also needed to determine the mechanism by which vitamin D affects inflammatory processes and, in turn, eases symptoms of MS. Additional co-authors from UCSF include Dorothee Chabas, MD, PhD; Jonathan Strober, MD; Jamie McDonald, BS; Jorge Oksenberg, PhD, and Peter Bacchetti, PhD. Co-authors from other institutions are Lauren Krupp, MD; Maria Milazzo, MS, CPNP, and Anita Belman, MD, all of the Pediatric MS Center, State University of New York at Stony Brook. The study was supported by a National MS Society Sylvia Lawry Fellowship Award and an additional grant from the National MS Society. Source: PRWEB (21/01/10)

Oral MS therapy FTY720 shows reduced risk of confirmed disability progression

Thu, 21 Jan 2010 02:31:00 EST

Results of the TRANSFORMS1 and FREEDOMS2 studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS). The data, from one of the largest Phase III programs conducted in MS, were included in the applications for regulatory approval submitted to the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) in December 2009. In both studies, two doses of FTY720 were examined (0.5 mg and 1.25 mg). Approval is sought for the lower 0.5 mg dose as the results from the studies indicate that this dose has the most positive benefit-risk profile. �Innovative science leading to new medicines for MS patients is greatly needed,� said John Richert, MD, Executive Vi ce President for Research and Clinical Programs at the US National Multiple Sclerosis Society. �The positive results published in The New England Journal of Medicine showing benefit of fingolimod on the clinical and MRI outcomes assessed is very encouraging for MS patients, their families and their physicians .� The one-year TRANSFORMS study involving 1,292 patients showed that oral FTY720 0.5 mg reduced relapses by 52% compared to interferon beta -1a (Avonex�)� given by intramuscular injection, while the reduction with FTY720 1.25 mg was 38% (both p<0.001). The two-year FREEDOMS study, involving 1,272 patients, showed that FTY720 reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the 1.25 mg dose compared to placebo (both p<0.001). Patients on FTY720 0.5 mg also had a 30% lower risk of disability progression, three-month confirmed (p=0.02) and a 37% lower risk of disability progression, six-month confirmed (p=0.01) over two years compared to 2/4 placebo. Similarly, the FTY720 1.25 mg dose reduced the risk of three-month and six month confirmed disability progression by 32% (p=0.02) and 40% (p=0.006) respectively. In both studies, treatment with FTY720 also resulted in statistically significant reductions in brain lesion activity and reduced loss of brain volume as measured by magnetic resonance imaging (MRI). �The TRANSFORMS data demonstrate the efficacy of fingolimod compared to a current standard of care. These findings may represent a real step forward in the fight against MS,� said Jeffrey Cohen, MD, TRANSFORMS study lead investigator and staff physician at the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research in Cleveland, Ohio, USA. �Current disease-modifying therapies for relapsing-remitting MS are administered by injection or infusion, which may negatively affect tolerability, convenience, and compliance for patients on these therapies.� Professor Ludwig Kappos, MD, principal investigator for the FREEDOMS clinical trial and Chair of Neurology and Research Group Leader in the Department of Biomedicine at the University Hospital in Basel, Switzerland, said: �FTY720 demonstrated clear clinical superiority over placebo in terms of reducing relapse rates and disability progression. The positive findings of TRANSFORMS and FREEDOMS give an increasingly complete understanding of the efficacy and safety of FTY720.� Up to 2.5 million people worldwide are affected by MS, an inflammatory and neurodegenerative condition that often begins when patients are in the prime of their lives 3. FTY720 has the potential to be the first approved therapy in a new class of drugs called sphingosine 1-phosphate (S1P) receptor modulators. These medicines reduce inflammation and may also have a direct beneficial effect on cells in the central nervous system (CNS). FTY720 acts selective ly by retaining certain lymphocytes (a sub-group of white blood cells) in the lymph nodes , reducing the number of lymphocytes that reach the brain where they can cause inflammatory destruction. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped. �These data demonstrate that oral FTY720 has the potential to offer an important new treatment option for patients with MS,� said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. �We have a long-term commitment to the MS community, and trust that FTY720, once approved, will prove to be a valuable treatment option for many people who live with this disease.� In both TRANSFORMS and FREEDOMS, adherence to therapy was best for the FTY720 0.5 mg and control groups compared to the 1.25 mg group. The most commonly reported adverse events for both FTY720 and control groups were nasopharyngitis, headache and fatigue. FTY720-related adverse events included dose-related, transient, generally asymptomatic heart rate reduction, infrequent transient AV conduction block, mild (1-3 mm Hg) blood pressure increase, macular edema (more common with 1.25 mg than the 0.5 mg target dose), and asymptomatic, reversible elevation of liver enzymes. The rates of infections overall, including serious infections, were comparable between treatment groups, although a slight increase in lung infections (primarily bronchitis) was seen in patients treated with FTY720. The number of malignancies reported in the two studies was small with comparable rates between the FTY720 and control groups; malignancies were reported more frequently with FTY720 than the control group in the one-year TRANSFORMS study but the opposite pattern was seen in the two-year FREEDOMS study.3/4 Serious adverse events were comparable between treatment groups, though generally slightly higher with the 1.25 mg than 0.5 mg dose. Overall rates of drug-related adverse events, particularly those related to the mechanism of action, as well as discontinuations due to adverse events , were more common with 1.25 mg than 0.5 mg. The completed MS FTY720 studies and their extensions include more than 2,300 patients with approximately 4,000 patient-years of exposure, including some patients now in their sixth year of treatment. Safety is also being monitored in approximately 1,000 additional patients in ongoing MS studies. The publication in The New England Journal of Medicine marks the first presentation of full results from the two studies. Top line results of FREEDOMS and TRANSFORMS have been disclosed in Novartis press releases, and the TRANSFORMS study has also been presented at scientific congresses 4. �Avonex� is a registered trademark of Biogen Idec. Dr. Jeffrey Cohen conducts research and is a paid consultant for Novartis. References 1 Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010 (printed version). 2 Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010 (printed version). 3 National Multiple Sclerosis Society website. Last accessed Jan 15, 2010. 4 Cohen J. et al. Oral Fingolimod (FTY720) Versus Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis: Results from a Phase III Study (TRANSFORMS). Slide deck associated with Oral Presentation at the American Academy of Neurology Annual Meeting 2009. [S21.004]. Source: Novartis International AG (21/01/10)

Oral Therapy for Multiple Sclerosis � Sea Change or Incremental Step?

Thu, 21 Jan 2010 01:51:00 EST

Oral Therapy for Multiple Sclerosis � Sea Change or Incremental Step? William M. Carroll, M.B., B.S., M.D., F.R.A.C.P. The long-awaited arrival of oral formulations for the treatment of relapsing-remitting multiple sclerosis is welcome news for the estimated 2.5 million people worldwide who have this chronic, disabling disease. Since the publication of the first pivotal trial of interferon beta-1b in 1993,1 practitioners and patients alike have been anticipating the approval of oral therapies because of the relative ease of administration, which should improve adherence and reduce restrictions on lifestyle. In this issue of the Journal, researchers report the results of three well-conducted trials of the first two oral agents, cladribine and fingolimod, in the treatment of multiple sclerosis. The researchers studied cladribine in the Cladribine Tablets Treating Multiple Sclerosis Orally (CLARITY) trial2 and fingolimod in the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) trial3 and the Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing�Remitting Multiple Sclerosis (TRANSFORMS).4 Although these two drugs differ in their mechanisms of action, both reduce the number of potentially autoaggressive lymphocytes that are available to enter the central nervous system. The articles, which report that the agents are effective and have manageable adverse-effect profiles, raise three questions: How do these therapies measure up against the existing treatments? Are all the longer-term adverse effects known? What do these drug trials tell us about multiple sclerosis and our treatment goals? Both cladribine (in the CLARITY trial) and fingolimod (in the FREEDOMS trial) were highly effective against placebo over a 2-year period, and fingolimod was more effective than intramuscular interferon beta-1a over a 12-month period (in the TRANSFORMS trial). Each of the three studies involved more than 130 centers in up to 32 countries, and the enrollments of 1272 to 1326 patients ensured that the trials were sufficiently powered to detect an effect of two doses of the active oral agent. Patients had active relapsing disease with durations of 7 to 9 years. On the Expanded Disability Status Scale (which ranges from 0 to 10, with higher scores indicating greater disability), patients had a median score of 2.0 in the fingolimod trials and mean scores ranging from 2.9 to 3.0 in the cladribine trial. All three studies used the annualized rate of relapse as the primary end point, and high and low doses of cladribine and fingolimod were shown to be superior to both placebo and interferon beta-1a. For cladribine versus placebo, the relative risk reduction in the annualized relapse rate was 57.6% for the group receiving 3.5 mg per kilogram of body weight and 54.5% for those receiving 5.25 mg per kilogram. For fingolimod versus placebo, the relative risk reduction was 54% for the 0.5-mg dose and 60% for the 1.25-mg dose. For fingolimod versus interferon beta-1a, the relative risk reduction was 52% for the 0.5-mg dose and 39% for the 1.25-mg dose. Both agents were superior to the comparators with respect to secondary end points, including measures on magnetic resonance imaging and a number of clinical end points, including the time to the progression of sustained disability at 3 months. Furthermore, although only fingolimod was tested against the widely used interferon beta-1a, it is likely that the two oral therapies will be at least as effective as other currently available disease-modifying therapies. In this regard, head-to-head trials of subcutaneous interferon beta-1b5 and interferon beta-1a6 versus intramuscular interferon beta-1a showed advantages of both subcutaneous regimens over the latter. More recent trials were unable to separate the clinical efficacy of the two subcutaneously administered forms of interferon beta from that of glatiramer acetate.7 Adverse effects were similar in all three trials of cladribine and fingolimod, and rates of events leading to discontinuation of a study drug were low but still at least twice as frequent with high-dose cladribine (7.9% for the 5.25-mg dose) and fingolimod (10% and 14% for the 1.25-mg dose). Herpetic infections occurred among patients receiving both cladribine and fingolimod. The rate of herpes infections among patients receiving the 1.25-mg dose of fingolimod was 5.5%; such infections were serious in three of these patients, two of whom died. Twenty cases of cutaneous herpes zoster were recorded among patients receiving cladribine, three of which were serious. Three solid tissue cancers (pancreatic, ovarian, and melanoma) occurred among patients receiving low-dose cladribine (3.5 mg per kilogram). Basal-cell carcinoma, melanoma, and breast cancer were all more common among patients receiving fingolimod than among those receiving interferon beta-1a. Macular edema was confirmed in 13 patients, 11 of whom received high-dose fingolimod (7 in the FREEDOMS trial and 4 in the TRANSFORMS trial). Of these 13 patients, 11 recovered within 1 to 6 months after discontinuation of therapy, and the condition of the other 2 patients stabilized. Transient bradycardia and first- and second-degree heart block occurred more frequently among patients receiving high-dose fingolimod than in the comparator groups. Lymphocytopenia was frequent in patients receiving both agents, more so with higher doses. Clinicians and patients will need to evaluate the risks and benefits of each of these drugs. Given the recent studies documenting the development of progressive multifocal leukoencephalopathy among patients receiving natalizumab, a monoclonal antibody against 4-integrin,8 close postmarketing surveillance will be important to detect any increase in these or other unexpected adverse effects. The mechanism of action of both oral agents represents a major change from those of currently available drugs for multiple sclerosis. Among a number of actions that are claimed for current therapies is that they change the emphasis of the immune response from activation of proinflammatory type 1 helper T cells to activation of antiinflammatory type 2 helper T cells. Even though cladribine is administered in two or four short courses annually, whereas fingolimod is given daily, both drugs were associated with persistent lymphocytopenia. Cladribine is resistant to the enzyme adenosine deaminase, which causes an accumulation of toxic deoxyribonucleotides in lymphocytes, resulting in relatively selective long-term depletion of CD4+ and CD8+ T cells.9 Fingolimod is a synthetic analogue of myriocin that is derived from a fungus (Isaria sinclairii). Once phosphorylated, the drug acts to down-regulate the sphingosine-1-phosphate receptor required for antigen-activated lymphocytes to egress, effectively locking them in the nodes.10 Thus, both cladribine and fingolimod are targeting inflammation, the key driver of immune injury in multiple sclerosis. Similarly, both natalizumab, which blocks lymphocyte access to endothelium in the central nervous system, and the anti-CD52 monoclonal antibody alemtuzumab, which destroys T and B cells, have shown impressive reductions in disease activity.11 Insights from these trials and others treating the initial stages of disease12 suggest that early direct targeting of the immune system offers the best hope for the prevention of later disability. The studies in this issue of the Journal provide a new horizon for patients with relapsing�remitting multiple sclerosis and a welcome increase in the range of treatment options. Although current therapies remain very effective, particularly when they are administered early, and have well-defined side-effect profiles, oral therapies further support a change in treatment approach to directly prevent immune-mediated injury. This approach will probably be followed until the next step in the therapeutic advance occurs, but such a change in strategy highlights the final question: What are the long-term goals of this new phase of therapy? The question will not be fully answered until the underlying cause of multiple sclerosis is better understood, but the lack of a definable end point remains a contentious issue for clinicians and health care funders alike. Time will determine the long-term effectiveness of these treatments in delaying the development of irreversible disability, and as ongoing, real-life experiments, they will contribute to our understanding of this enigmatic disease. References The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993;43:655-661. Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010. DOI: 10.1056/NEJMoa0902533. Kappos L, Radue E-W, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010. DOI: 10.1056/NEJMoa0909494. Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010. DOI: 10.1056/NEJMoa0907839. Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002;359:1453-1460. Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the Evidence Trial. Neurology 2002;59:1496-1506. Achiron A, Fredrikson S. Lessons from randomised direct comparative trials. J Neurol Sci 2009;277:Suppl 1:S19-S24. Iaffaldano P, D'Onghia M, Trojano M. Safety profile of Tysabri: international risk management plan. Neurol Sci 2009;30:Suppl 2:S159-S162. Sipe JC. Cladribine for multiple sclerosis: review and current status. Expert Rev Neurother 2005;5:721-727. Massberg S, von Andrian UH. Fingolimod and sphingosine-1-phosphate -- modifiers of lymphocyte migration. N Engl J Med 2006;355:1088-1091. The CAMMS223 Trial Investigators. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med 2008;359:1786-1801. Goodin DS, Bates D. Treatment of early multiple sclerosis: value of treatment initiation after a first clinical episode. Mult Scler 2009;15:1175-1182. Source: The New England Journal Of Medicine (10.1056/NEJMe0912019) � 2010 Massachusetts Medical Society. (21/01/10)

Interferon-gamma-producing T cells, pregnancy, and postpartum relapses of multiple sclerosis

Wed, 20 Jan 2010 04:15:00 EST

It is well known that in women with MS, the relapse rate decreases during pregnancy and can increase after delivery. The authors of this study propose that this increase of the relapse rate after pregnancy may be related to an immunological process (reflected by the decline in a specific type of immune cell) which starts during late pregnancy. They also suggest that this process can be interrupted by lactational amenorrhea (physiological suppression of menstruation while nursing) induced by exclusive breastfeeding. OBJECTIVE: To determine whether fluctuations in functional T-cell subsets can explain why multiple sclerosis (MS) relapses decline during pregnancy and increase in the postpartum period. DESIGN: Case-control study. SETTING: Kaiser Permanente Northern California and Stanford University. PARTICIPANTS: Twenty-six pregnant women with MS and 24 age-matched, pregnant controls. Intervention We prospectively followed up the pregnant women with MS and the age-matched, pregnant controls; conducted structured interviews; and collected peripheral blood mononuclear cells during each trimester and 2, 4, 6, 9, and 12 months post partum. MAIN OUTCOME MEASURES: Sixteen functional cell types, including interferon-gamma (IFN-gamma)- and tumor necrosis factor-producing T-cell subsets, were measured using multicolor flow cytometry. Since these cell types may also fluctuate with pregnancy, lactational amenorrhea, or MS treatment, the data were analyzed taking into account these factors. RESULTS: Fifteen women with MS (58%) had relapses during the postpartum year. CD4(+)IFN-gamma-producing cells fluctuated with MS relapses, declining during pregnancy in women with MS (P < .001) and continuing to decline after parturition in women with relapses (P = .001), yet rising or remaining stable in women with nonrelapsing MS or healthy pregnant women. Lactational amenorrhea was associated with a rise in CD4(+)IFN-gamma-producing cells in women with MS (P = .009). In contrast, CD4(+) tumor necrosis factor-producing cells decreased during lactational amenorrhea in all groups of women and, once this was taken into account, obscured any relationship to MS relapses. CD8(+)IFN-gamma-producing cells were elevated in women with MS throughout the study (P < .001) but did not fluctuate with relapses. CONCLUSIONS: Our findings suggest that a decline in circulating CD4(+)IFN-gamma-producing cells leads to postpartum MS relapses. Our findings also suggest that the decline in these cells may begin during late pregnancy and that lactational amenorrhea induced by exclusive breastfeeding may be able to interrupt this process. Langer-Gould A, Gupta R, Huang S, Hagan A, Atkuri K, Leimpeter AD, Albers KB, Greenwood E, Van Den Eeden SK, Steinman L, Nelson LM. Department of Health Research and Policy, School of Medicine, Stanford University, Stanford, CA 94305, USA. Source: Pubmed PMID: 20065129 (20/01/10)

Collaboration to accelerate development of treatments for Multiple Sclerosis and Type 1 Diabetes

Wed, 20 Jan 2010 02:51:00 EST

Fast Forward, LLC, the commercial drug development arm of the National Multiple Sclerosis Society, and the Juvenile Diabetes Research Foundation (JDRF), the leader in research leading to a cure for type 1 diabetes in the world today announced a collaborative partnership with Axxam SpA -- a leading company in conducting early-stage discovery research programs for the life science industry -- to develop new treatments for two autoimmune diseases, multiple sclerosis (MS) and type 1 diabetes (T1D). Under the terms of the agreement, Axxam will screen its extensive chemical library to identify compounds that can target specific ion channels in the immune system. Ion channels are tiny pores on the surface of immune cells that control the influx of charged particles and allow the cells to become activated to perform their natural surveillance and protection functions. Recent studies have found that immune cells in MS and T1D contain high levels of a specific ion channel, Kv1.3, and that the hyperactivity of this channel contributes to the dysfunction of the immune system in MS and T1D. If the initial research is successful, Axxam will have identified compounds that modulate Kv1.3 ion channel activities, and these will be further developed by the company as potential therapies for MS and T1D. The agreement with Axxam is the first of its kind between cross-disciplinary patient advocacy organizations and represents a new frontier in which groups such as JDRF and Fast Forward ally to lessen the risk of drug discovery and accelerate the development of new therapies that can impact multi-disorders. "We are pleased to partner with Axxam and JDRF to advance the development of new treatments for T1D and MS," said Dr. Timothy Coetzee, President of Fast Forward. Adds Dr. Coetzee, "People with MS and T1D need more treatment options and the approach taken by Axxam holds great promise for both diseases." "Our partnership with Fast Forward and Axxam opens exciting new avenues for JDRF to speed the translation of basic research into drugs and treatments for type 1 diabetes," said Alan J. Lewis, PhD, President and Chief Executive Officer of JDRF. "Research into the Kv1.3 ion channel has the potential to negate the autoimmune process causing type 1 diabetes and multiple sclerosis, which must be addressed to cure these diseases." "It's rewarding for Axxam to be working with two world class non-profits dedicated to speeding new therapies to their constituencies," said Dr. Stefan Lohmer, Ph.D., Chairman and Chief Executive Officer of Axxam. "This collaboration recognizes the quality of our research in the challenging ion channels field and we hope to be on the cusp for developing potential new therapies for both type 1 diabetes and multiple sclerosis." Source: Juvenile Diabetes Research Foundation (20/01/10)

Novel mouse model of demyelinating disorder

Mon, 18 Jan 2010 04:10:00 EST

In the February 1st issue of G&D, Dr. Brian Popko (The University of Chicago) and colleagues describe how mutation of a gene called ZFP191 leads to disordered CNS myelination in mice -- reminiscent of what is seen in human multiple sclerosis (MS) patients. MS is a chronic autoimmune disorder, in which the body attacks and destroys the myelin sheath that insulates and protects nerve fibers of the central nervous system (the brain, spinal cord and optic nerves). Demyelination disrupts the conduction of electrical impulses along nerve fibers, and results in regional neural deficits. MS symptoms range from tingling and numbness in limbs, to loss of vision and paralysis. It is estimated that MS affects 400,000 people in the US and approximately 2.5 million worldwide. Dr. Popko and colleagues identified a gene called ZFP191 as being necessary for the development of oligodendrocyte cells, which - in their fully mature form - produce myelin. The researchers found that mice harbouring a single mutation in ZFP191 display tremors and seizures, caused by a severe deficiency in CNS myelination. ZFP191 appears to be the first factor identified to be critical for the myelinating function of oligodendrocytes. The failure of Zfp191-mutant mouse oligodendrocytes to successfully myelinate their targets is reminiscent of human MS lesions, where re-myelination of damaged tracts fails to occur efficiently even when apparently mature oligodendrocytes are present in the area. While further research to delineate the precise targets of ZFP191 is needed, this work holds promising clinical value as a potential therapeutic pathway to promote re-myelination, reduce the accumulation of MS lesions and slow disease progression. Source: Medical News Today � 2010 MediLexicon International Ltd (18/01/10)

Pioneering surgery for MS clears British woman of disease symptoms

Sun, 17 Jan 2010 03:05:00 EST

Doctors believe they have cured a British woman of �multiple sclerosis after a pioneering operation. For years sufferers have been told there is no cure for MS, but the apparent success of the surgery has given new hope to those who are battling the disease, which attacks the nervous system. And Alex Gibbs is so certain she has now beaten the disease that she has even become pregnant � something she would never have dared do before. Alex, 38, travelled to the United States last June after reading on the internet about the breakthrough procedure, which involves widening the veins. She contacted surgeons in the UK and asked them to perform the surgery but none would agree. Alex, from Chelsea, West London, said: �I�ve only had MS since 2004. But I got it really badly right from the start. �I couldn�t walk more than 300ft without having to stop. I had stiff limbs and muscle spasms through the night in my sleep. �My future didn�t look very good having such �severe MS at the outset. Normally it worsens slowly. Within a couple of years I would probably have been in a wheelchair.� Many �experts believe MS is caused by a faulty immune system, but a number of �doctors now believe damage caused to the nervous system in MS is actually from poor blood flow in the chest, neck and head. One is Italian surgeon Paulo Zamboni, whose solution is to widen the veins using a �balloon or thin metal tubes. Alex had followed the work of Prof Zamboni, who cured his wife of MS five years ago and has now cured 100 more patients. As no UK doctors who specialise in MS are prepared to carry out Zamboni�s procedure until further studies are carried out, Alex went to �California, where a �surgeon at Stanford �University was willing to perform the �procedure. After the �5,000 op which widened her jugular veins, Alex�s symptoms improved immediately. Alex � whose mum died of MS at 68 � just months before she was diagnosed, reported back to her MS �consultant at the National Hospital in London. She said: �He�s not �convinced by Zamboni�s research, but he has accepted that my symptoms have �improved. And the lesions on my brain caused by the MS have not worsened.� Source: sundaymirror.co.uk � Mirror Group Newspapers 2010 (17/01/10)

European application for Fampridine-PR tablets to aid walking in Multiple Sclerosis submitted

Thu, 14 Jan 2010 02:54:00 EST

Biogen Idec has announced the submission of a marketing authorization application (MAA) to the European Medicines Agency for Fampridine Prolonged Release (Fampridine-PR) tablets, a novel oral therapy for the improvement of walking ability in adult patients with multiple sclerosis (MS). The company also has filed a New Drug Submission (NDS) to Health Canada. "Walking impairment has a significant impact on the lives of many people living with MS," said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec. "Fampridine-PR tablets may offer a novel approach to address this debilitating aspect of the disease by improving the walking ability of MS patients. We look forward to working with regulators to make this therapy available to people with MS in Europe and Canada." The MAA submission and Canadian NDS are based on a comprehensive development program including results from two Phase III, randomized, double-blind, placebo-controlled studies. These studies demonstrated the efficacy of Fampridine-PR tablets in improving walking ability in patients with relapsing-remitting, secondary progressive, progressive relapsing, and primary progressive MS. In the two Phase III clinical trials, a significantly greater portion (p<0.001) of Fampridine-PR-treated patients had a consistent improvement in walking speed when compared to placebo (34.8 percent vs. 8.3 percent and 42.9 percent vs. 9.3 percent, respectively). The increased response rate of the Fampridine-PR group was observed across all types of MS included in the studies. The Fampridine-PR treated subjects who had consistent improvement in the two studies experienced an average increase in walking speed of 25.2 percent and 24.7 percent compared to 4.7 percent and 7.7 percent, respectively, for the entire placebo group. The majority of the study participants in these trials were using immunomodulatory drugs, including interferons, glatiramer acetate, and natalizumab; however the magnitude of improvement in walking ability was independent of concomitant therapy. Source: Biogen Idec (14/01/10)

Tysabri sales top $1 billion, new patients grow 30 percent

Wed, 13 Jan 2010 07:04:00 EST

Biogen Idec Inc. said sales of its multiple sclerosis drug Tysabri topped $1 billion in 2009, and there were 30 percent more new patients taking the drug. The growth comes as the rate of a potentially fatal side effect in patients taking Tysabri remains a lingering concern for Wall Street. In 2005, the drug was pulled from the market because of concerns over a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML. Sales resumed in July 2006 with restrictions, though about two dozen cases have since been reported, mainly abroad. In 2009, sales reached $1.06 billion, with $508.5 million in the U.S. and $550.7 million internationally. A key concern has been that fears of the brain infection could bog down the addition of new patients. At the end of 2009, there were 48,800 patients taking Tysabri worldwide, including 24,500 in the U.S. and 23,700 internationally. An additional 600 patients were taking the drug in clinical trials. Several analysts said the rate of new patients adding the drug is slowing. Leerink Swann analyst Dr. Joshua Schimmer said about 2,600 started taking the drug during the fourth quarter, down from more than 2,900 in the third quarter. But he said much of the concern is already included in outlooks for the company. He reaffirmed an "Outperform" rating on the stock and said Tysabri revenue is in line with Wall Street expectations. Looking ahead, the company has said it will focus on accelerating growth of Tysabri and its top seller, the multiple sclerosis drug Avonex. Source: San Francisco Examiner copyright SF Newspaper Company 2010 (13/01/10)

Could multiple sclerosis by caused by blocked veins?

Tue, 12 Jan 2010 04:52:00 EST

Five years ago, opera singer Joan Beal had one of those life-changing shocks when her husband Jeff was told he had multiple sclerosis. She and Jeff, an Emmy-award-winning musical director, had been married for more than 20 years and the news came as a huge blow. The diagnosis was bad enough, but just as distressing was that the treatment - anti-inflammatory drugs and chemotherapy - was aimed only at reducing symptoms. What Joan wanted to know about was the underlying cause. 'Jeff was really sick by the time he agreed to see the doctor,' she says. 'He was numb on his left side and his feet were burning. When they ran tests on him, he also had signs of liver damage and little blood spots all over his shins and ankles. 'When I asked the neurologist why he was so sick, she said Jeff needed to stop drinking. That was flippant and made me angry because Jeff didn't touch alcohol.' The encounter sent Joan off on a search for a better approach, and in May Jeff became one of the first in the world to have a new and controversial operation based on a radical theory about the cause of MS. Seven months later, the improvement has been dramatic. 'Jeff had immediate and profound relief of very severe fatigue,' says Joan. 'Before the op he had trouble getting out of bed and needed naps during the day. Since then, he has had no MS attacks (when symptoms get much worse). He still has leg pain, spasms and headaches, but these are less than before.' So, has Joan Beal discovered an effective treatment for MS? MS affects around 100,000 people in the UK. The conventional view is that it's an auto-immune disease, like rheumatoid arthritis. For some reason, the body turns against itself and starts destroying the myelin, the insulating fatty layer around nerve cells in the brain and spinal cord. This affects how messages are transmitted in the brain, causing the classic symptoms of MS, including vertigo, numbness, temporary vision loss and crushing fatigue. It can also cause paralysis and incontinence. Jeff's operation was inspired by a new theory about why the myelin gets destroyed - it's thought MS is a disease of the blood vessels, specifically the veins. The doctor at the forefront of this approach is Dr Paolo Zamboni, a professor at the University of Ferrara in Italy. He began investigating MS when his wife Elena, 51, developed the disease ten years ago. He examined MS patients with ultrasound and found that in nearly all, the veins leading from the brain had signs of narrowing, twisting and blockage; something he didn't find in healthy patients. He saw that blockages were allowing iron from the blood to leak into the brain tissue, where it causes damage. Dr Zamboni called the condition chronic cerebrospinal venous insufficiency (CCSVI). He calculated that by clearing the blockage in the main neck vein, he could help reverse MS symptoms. To do this, he used a technique known as angioplasty - inserting a tiny balloon into the blocked vein and then blowing it up to open up the blood vessel. It is a standard procedure for expanding the arteries of heart patients. By the time Joan found out about Dr Zamboni, he'd operated on 65 MS patients - including his wife, who is symptom free three years after surgery. Of those, 50 per cent were 'relapse-free' for at least 18 months compared with only 27 per cent in a control group who didn't have the operation. Inspired by his findings, Joan contacted one of the top cardiology experts in the U.S. who has pioneered the use of stents - another standard procedure opening blocked arteries - and sent him reports of Professor Zamboni's work. He agreed to scan the veins in Jeff's neck. 'When we saw Jeff's mangled veins on the MRI scan,' says Joan, 'our doctor was amazed. He said he'd never seen this in the jugular veins before. The left one was closed 95 per cent, the right 80 per cent.' Just why the veins get blocked isn't clear. Dr Zamboni believes it could be a structural problem that is present from birth. Jeff had stents put into his neck veins at Stanford University hospital in California. After describing the success of Jeff's operation on an internet MS bulletin board (thisisms.com), Joan was inundated with requests for more information. And the cardiologist was swamped with requests for the operation. So much so that he has asked for his name to be withheld. But in the past seven months he has operated on 70 MS patients and many of them have posted reports on the website. One wrote: 'Less spasticity in left leg; facial pain is gone; right side back pain is gone; normal sweating; high altitude headaches gone; walking gait is smoother. No progression since intervention.' But the accounts don't gloss over the potential side-effects of the operation; these include nerve damage that stents can cause and bleeding in the stomach as a result of drugs used in the operation. So is this a breakthrough in the treatment of MS? Dr Robert Zivadinov, leading a study for more evidence at Buffalo University in New York, says: 'If we can prove the hypothesis that CCSVI is the underlying cause of MS, then it is going to change the face of how we understand the disease.' But the theory has attracted criticism. Dr Alasdair Coles, an academic neurologist at Cambridge University, says: 'We know MS is an auto-immune disease because if you block the immune response with drugs, people get better.' Dr Susan Kohlhaas, of the UK MS Society, adds: 'Our experts don't accept that blockages to draining veins from the brain are specific to people with MS or that this explains the cause of MS.' There have been many false dawns in MS research. The cause of the damage has been linked with lack of vitamin D, lack of the hormone prolactin, mercury fillings and now CCSVI is added to the list. Joan and many others pray that it's not another example of offering false hope. Source: Daily Mail � Associated Newspapers Ltd (12/01/10)

Wedge-shaped medullary lesions in multiple sclerosis suggestive of an impairment of venous drainage

Mon, 11 Jan 2010 03:50:00 EST

Multiple sclerosis (MS) is a heterogeneous disease with variable clinical features and magnetic resonance imaging (MRI) findings. We report four MS cases with unusual wedge-shaped lesions in the paramedian ventral medulla oblongata demonstrated on MRI. The clinical features and MRI characteristics of the medullary lesions suggest an impairment of venous drainage. We propose that the formation of these wedge-shaped lesions may be related to the pattern of venous drainage in the ventral medulla and raised venous pressure due to chronic cerebrospinal venous insufficiency which has recently been described in MS. Qiu W, Raven S, Wu JS, Carroll WM, Mastaglia FL, Kermode AG. Centre for Neuromuscular and Neurological disorders, University of Western Australia, Australia; Department of Neurology, Sir Charles Gairdner Hospital, Queen Elizabeth II Medical Centre, Perth, Western Australia, Australia; Department of Neurology, the Third Affiliated Hospital of Sun yat-sen University, Guangzhou, China. Copyright � 2010 Elsevier B.V. All rights reserved. Source: PubmedPMID: 20056253 (11/01/10)

Additional $860,000 grant for oral Estriol Multiple Sclerosis clinical trial announced

Mon, 11 Jan 2010 03:16:00 EST

Adeona Pharmaceuticals, Inc., has announced that the ongoing clinical trial of its Trimesta� (oral estriol) drug candidate being conducted by Dr. Rhonda Voskuhl, Director, UCLA Multiple Sclerosis Program, UCLA Dept. of Neurology has received an additional $860,440 in grant funding through the American Recovery and Reinvestment Act. The current phase II/III clinical study is a double-blind, placebo-controlled trial taking place at sixteen sites in the US and will enroll up to 150 female Multiple Sclerosis (MS) patients. Investigators will administer Trimesta along with glatiramer acetate (Copaxone�), an FDA approved therapy for MS, to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. This ongoing clinical trial previously received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH). According to Dr. Voskuhl, "This additional funding has already had a very positive impact on our trial. It has greatly increased the rate of enrollment by supporting the addition of 9 more clinical sites, bringing the total up to 16 sites across the US. We were extremely pleased that our trial was deemed important enough to be supplemented with these additional funds." Previous Phase II Clinical Trial Results in Relapsing Remitting Multiple Sclerosis Trimesta (oral estriol) has previously completed an initial 22-month, single-agent, crossover Phase I/II clinical trial in the US for the treatment of MS in relapsing remitting patients, with highly encouraging results. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with Trimesta. Following a six-month drug holiday during which the patients weren't on any drug therapies, Trimesta therapy was reinitiated during a four-month retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88 percent (p=0.008) and a decrease in the number of lesions by 48 percent (p=0.04) compared with original baseline scores (1),(2). Improvement in Cognitive Testing Scores During the prior Phase I/II clinical trial, a 14-percent improvement in Paced Auditory Serial Addition Test ("PASAT") cognitive testing scores (p=0.04) was also observed in the MS patients at six months of therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS. The PASAT scores were expressed as a mean percent change from baseline and were significantly improved in the relapsing-remitting group. About the Trimesta Phase II/III Study In the current phase II/III study, Trimesta is being given orally once-a-day versus placebo to 150 female relapsing-remitting MS patients in combination with a standard of care background therapy, subcutaneously injected glatimer acetate. The primary endpoint for the study will evaluate effects of the treatment combination on relapse rates at two years with a one year interim analysis using standard clinical measures of MS disability as well as secondary endpoints of magnetic resonance imaging measurements of brain lesion and effects on cognition. The study is approaching 50% enrollment with the rate of enrollment benefiting significantly from the expansion of clinical sites. Source: Adeona Pharmaceuticals, Inc (11/01/10)

Progesterone can shield brain from injury and possibly demylienation

Wed, 30 Dec 2009 03:58:00 EST

Progesterone, a hormone that increases tenfold during pregnancy, is thought to help the developing fetus by protecting it from oxidative stress and aiding neuron development. But a growing body of research leads some doctors to think it could also be a useful first-line treatment after a traumatic brain injury (TBI) or stroke. In an article published in the January issue of the American Journal of Roentgenology, researchers argue that a spate of recent studies have shown that the hormone might be the first compound after 30 years of testing to protect the brain during acute-stage TBI. And if given to patients in time, the hormone might protect cognitive function and even save lives. In a recent phase 2 clinical trial with 100 subjects sponsored by the National Institute of Neurological Disorders and Stroke, researchers say patients with moderate-to-severe brain injuries given the hormone intravenously for three days were more than twice as likely to survive: mortality rates were around 14 percent for the hormone versus about 30 percent for placebo. Another recent study, this one in China with 159 patients, had similar results. And while the doctors don't know if the findings will apply to humans, work on rats with strokes caused by blocked middle cerebral arteries has shown better brain function following the attack if given the hormone. This is critical because currently only about 3-5 percent of stroke patients can be treated with tissue plasminogen activators (tPA), a blood thinner that breaks up clots and the only real first-line treatment for strokes currently used. The reason most stroke victims can't get the drug is that doctors have to be absolutely certain the patient is suffering a stroke, otherwise it could cause deadly internal bleeding. And to work, it has to be administered within the first 3� hours. Progesterone, by contrast, has shown no adverse effects in any of the studies, and appears to have a wide window, about 24 hours, in which it can work. How it works "It's a hormone, in my opinion, that's evolved to protect the fetus," says Donald Stein, Ph.D., a researcher at Emory University and the lead author of the paper. "A lot of mechanisms in repair, not only in the brain but in all highly traumatized tissue, while not identical in development are similar." The hormone, which can cross the blood-brain barrier, appears to protect neurons in a variety of ways, by preventing injured brain cells from committing suicide and also by blocking the agents that break down their myelin sheaths. But perhaps most critically, it seems to prevent one of the main dangers of brain trauma: swelling. "One of the things about swelling in the brain, called cerebral edema from, say, injuries in the battlefield, is...that it can kill somebody if not controlled," says Dr. Stein. "And what progesterone has been shown to do effectively is to basically dramatically reduce inflammation and subsequently swelling," he says. On top of all this, progesterone and its army of metabolites also interfere with glutamate production, a neurotransmitter that floods regions following a trauma. Glutamate, along with other brain chemicals released in injury, can help overexcite the brain and lead to post-traumatic epileptic seizures. That's why progesterone is sometimes given to women with certain forms of seizures to prevent the triggering of debilitating neuronal "electric storms." Future studies But how well the hormone really holds up in preventing lasting damage following TBI will be revealed soon. Dr. Stein says a NINDS-sponsored phase 3 double-blind randomized trial, running at 17 centers and expected to handle upwards of 1,200 patients, should start next month. Source: DOTmed.com �2001-2009 DOTmed.com, Inc.(30/12/09)

Shine On Scotland now campaign to fortify school milk with Vitamin D

Wed, 30 Dec 2009 02:43:00 EST

When 14 year old Ryan Mclaughlin started his Shine on Scotland campaign he had set a goal to get vitamin D into our school milk, a simple idea to protect every child in scotland from Multiple Sclerosis, but he quickly became aware that far more diseases would benefit from vitamin D supplementation not just MS. Now the country's largest private health care provider BUPA agree�s and says we should all be taking between 1,500 to 2,000 IUs per day to beat cancer. This is 5 times the current UK RDA and exactly what Ryan has campaigned tirelessly for almost 9 months. Dr Virginia Warren, assistant medical director for Bupa, commented: �There has been a lot of research over the last few years about the health benefits of taking a vitamin D supplement. Based on this evidence, we would recommend taking between 37.5 and 50 micrograms of vitamin D on a daily basis to help reduce your risk of certain cancers. Spending time outside in summer will also increase your vitamin D levels, but is a risk for skin cancer. "Ensuring you get enough vitamin D is a simple and effective way to reduce your risk of developing certain cancers. Alongside this, it�s important to ensure you eat a healthy balanced diet, exercise regularly, only drink in moderation and do not smoke." It was again reinforced today when the Israeli Health Ministry announced that all 3% milk is to be fortified with vitamin D in the next 3 months and Ryan McLaughlin wants the Scottish Government to look to follow suit. Last week on a STV news interview with Ryan McLaughlin in relation to his win for vitamin D campaign he said �that fortification of school milk was still at the top of his priorities� as he still thinks its the best way to protect future generations of Scots from many diseases not just MS, this announcement by the Israeli Government only goes to further back his case and show that it can be done on a national basis and with the worst health record in western world and the highest rates of MS in the world � Scotland must take the lead. Dr Sareeram Ramagopalan of Oxford University and Ryan�s family all gave evidence at the Scottish Parliaments petitions committee back in June and told the committee that Israel was looking at fortification of both Milk and flour and we heard that France was also looking at it, now its been confirmed in Israel we need to really start considering moving towards fortification of the school milk program now in scotland. There are many problems associated with just offering supplementation, simply try getting a child to take a supplement every day for their young life seems doomed for failure, Ryan says he has forgotten a few times to take his and he is running the vitamin D camapign! How many adults get a course of antibiotics which state finish the course and don�t. Ryan says �I am sure almost every adult can say that take them till they feel better and the rest is left in a medical cabinet�. Furthermore do we really want kids popping tablets everyday? Can we ask our teachers to dish out supplements he doesn't think so. We would need to ask the questions from the Education Dept, teachers and of course get the teachers unions to agree to it, teachers have a big work load already, Ryan points out that many parents will be able to relate to the following point? How many times as a parent have you been called home and had to take a day off work when a paracetamol would sorted a sore head or a slightly high temperature and the child could have stayed in school getting educated � It would all take too long, too many problems to overcome. We could spend millions of pounds trying to educate parents and expectant mothers to take vitamin D supplements everyday, but I believe we should lead from the front from the start , we owe it to the kids and we must protect each and every child in Scotland. If parents don�t want it for their kids � let them simply opt out! Ryan believes we need to think much much bigger! He think we should educate parents to the idea of the benefits of vitamin D everyday and proposing putting vitamin D into the school milk programme so kids get it every day, start debating it with the public and informing parents immediately. Vitamin D boosts your immune system to help fights off cold and bugs and it would improve the school attendence records on wasted days of school due to simple sniffles, as well as save parents the loss of earnings by taking time off work with sick kids that could be in school learning. Add his very valid points to the figures compiled for national supplementation of vitamin D in Scotland in relation to just MS alone and you have very good case � Scientists believe it could prevent 2000 cases over 10 years in Scotland alone and could save the UK economy some �4.5 billion surely children�s health must be the priority and a penny onto the cost of a pint of milk is well justified and we should start talking to the dairies immediately! Source: Shine On Scotland (30/12/09)

Proof of principle clinical trial of ATX-MS-1467 for Multiple Sclerosis

Thu, 24 Dec 2009 02:00:07 EST

Apitope International NV, the autoimmune peptide therapy company, and Fast Forward, LLC, the National Multiple Sclerosis Society's subsidiary devoted to bridging the gap between research and drug development, today announced a partnership to support Apitope's proof of principle clinical trial of ATX-MS-1467. This peptide therapeutic vaccine is designed to target and prevent the abnormal pathological immune response in multiple sclerosis (MS). The agreement with Apitope is the first in a series of partnerships between Fast Forward and early stage biotechnology companies. "We are pleased to partner with Apitope to accelerate the development of innovative therapies for MS," said Dr. Timothy Coetzee, Fast Forward's Executive Director. "ATX-MS-1467 has the potential to redirect the immune system in MS which is essential to minimizing the damage to the nervous system in this highly debilitating disease." Adds Dr. Coetzee "We are concerned about the small number of therapies in development for MS relative to other diseases and the impact that the current economic climate will have on development of new treatments for people with MS. Fast Forward is committed to reversing this trend by deploying its resources to spur development of innovative MS therapies and bring them to market as quickly as possible............." For the full report please go to MSRC: MS Research News : Drugs : ATX-MS-1467

Evaluation of the safety and efficacy of sildenafil citrate for erectile dysfunction in men with Multiple Sclerosis

Wed, 23 Dec 2009 10:00:10 EST

The etiology of multiple sclerosis (MS)-emergent erectile dysfunction (ED) is still matter of debate, since both organic and psychological factors have been implicated. There is an association between sexual dysfunction (SD) and destructive lesions in the pons, in MS patients. Central and peripheral nerves systems play a key role in the erectile process. The innervation of the penis is both autonomic (sympathetic and parasympathetic) and somatic (sensory and motor). Pudendal nerves have a central role in erection. Tactile stimulation of the penile shaft activates parasympathetic fibers, which travel in the pudendal nerve and function through the spinal reflex arc from S2 to S4. Neural signals originating in the brain are transmitted to a thoracolumbar erection center and trigger the psychogenic erection associated with either fantasy or viewing erotic material. In addition, the ischiocavernosus and bulbospongiosus striated muscles, which located at the penile crus, are innervated by the motor pudendal nerve. Contraction of these muscles has a definite, contributory role in penile erection. Therefore, erection is a neurovascular event, and any disease or dysfunction affecting the brain, spinal cord, or cavernous and pudendal nerves can induce ED. With respect to placebo, sildenafil produced a 16% greater success rate for vaginal penetration, and a 15% greater rate for successful intercourse. For satisfaction with erection hardness, and satisfaction with the sexual experience, sildenafil did not produce two-fold greater rates. For all efficacy variables, sildenafil had similar or slightly greater scores compared with placebo................. For the full report please go to MSRC: MS Research News : Drugs : Viagra (sildenafil)

Potential autoimmunity-inducing cells found in healthy adults

Wed, 23 Dec 2009 02:00:14 EST

It's not just patients with autoimmune diseases like Lupus and Multiple Scelrosis (MS) that have self-attacking immune cells - healthy people have them too, according to a new report in the Journal of Experimental Medicine. In healthy adults, however, these cells are maintained in an 'off' state, perhaps explaining their innocuous nature. Whether these cells are the true predecessors of the self-attacking cells prevalent in Lupus and MS and, if so, what prevents them from causing disease in everyone is not yet known. As antibody-producing B cells develop in the bone marrow, the body tests them to determine whether their antigen receptors are apt to confuse self tissues for intruders. If so, their receptors are either rearranged to make new, non-autoreactive versions-a process called 'receptor editing'-or the cells are killed off while still in the bone marrow. Yet a minority manages to escape, slipping into the body as mature B cells with a propensity for self-attack...................... For the full report please go to MSRC: MS Research News : New Discoveries : Antibodies, B Cells,T-Cell Activation and Immune Response

Welsh government called upon to follow Scottish in vitamin D deficiency awareness

Tue, 22 Dec 2009 02:02:00 EST

The Welsh Assembly Government has been called upon to fund a campaign about vitamin D deficiency and multiple sclerosis. The MS Society Cymru is calling for ministers to follow Scotland�s lead and raise awareness about the links between the two. Such a campaign would encourage pregnant women and children under four to take a regular vitamin D supplement. Scientists recently discovered that MS could be prevented through daily vitamin D supplements.There is a clear link between vitamin D � known as the sunshine vitamin � and a gene that increases the risk of MS, raising the possibility that the debilitating auto-immune condition could be eradicated. The prevalence of MS is far higher in typically wet and cold countries such as Wales, where 110 people in every 100,000 are living with the condition. In a country with lots of sunshine � such as Brazil � only 18 people in every 100,000 have MS. The NHS in Scotland said it would raise awareness about the links between vitamin D deficiency and MS this month, after being spurred into acting by Glasgow teenager Ryan McLaughlin. Ryan�s mother, Kirsten, has had MS for three years, and Ryan, 14, has shown some symptoms of the disease but the family only discovered the link earlier this year after a family holiday. The teenager said: �I was shocked there had not been publicity around this before. We wanted there to be more awareness of the link and more research into how much of a problem it is in Scotland.�These actions will make a big difference � it will go a long way to giving children some protection against the disease and give parents proper advice.� Joseph Carter, spokesperson for MS Society Cymru, said: �We are delighted by this announcement by the Scottish Government and are now calling on the Welsh Assembly Government to do the same.�You are 10 times more likely to develop MS in Rhyl than you are Rio de Janeiro, and new research suggests this is due to vitamin D deficiency.� Vitamin D, obtained from foods and through the action of sunlight on skin, is essential for maintaining healthy bones.It is unclear exactly what causes MS but it has become increasingly evident that environmental and genetic factors play a role. Previous research has shown that populations from Northern Europe have an increased MS risk if they live in areas receiving less sunshine.This supports a direct link between deficiency in vitamin D, which is produced in the body through the action of sunlight, and increased risk of developing the condition. Researchers at the University of Oxford and the University of British Columbia this year discovered a direct relationship between the genetic variant DRB1*1501, which is associated with MS, and vitamin D. Dr Julian Knight, a co-author of the research, said: �In people with the DRB1 variant associated with MS, it seems that vitamin D may play a critical role.�If too little of the vitamin is available, the gene may not function properly.� And the study�s lead author Dr Sreeram Ramagopalan said: �Our study implies that taking vitamin D supplements during pregnancy and the early years may reduce the risk of a child developing MS in later life.� A spokeswoman for the Welsh Assembly Government said: �We are working closely with the MS Society to raise awareness of multiple sclerosis.�Earlier this year, we produced a leaflet, Multiple Sclerosis � living with a long term condition. This includes information on the condition, its symptoms and the people affected.� Source: Shine On Scotland (22/12/09)