MSRC Latest MS Research News

Clinical trial update on therapeutic effects of combined treatment with ribavirin and tiazofurin for MS

Fri, 03 Jul 2009 09:36:00 EST

Clinical trial update on therapeutic effects of combined treatment with ribavirin and tiazofurin for MS Hard To Treat Diseases (HTDS) Chief Scientist with its Slavica BioChem subsidiary, Dr. Sanja Pekovic provided updates on recent clinical trials with animal subjects in regards to the use of Ribavirin And Tiazofurin for the potential treatment of Multiple Sclerosis (MS). Dr. Pekovic reported; "It is now well accepted that axonal injury begins at an early stage in MS, and likely accounts for clinical progression seen later in the disease course, suggesting that early, aggressive treatment is critical in order to suppress long-term disability progression. Researchers from IBISS group (a related research group) tested the effect of combined treatment with ribavirin (R) and tiazofurin (T) administrated during the effecter phase of disease." Dr. Pekovic added: "We are hopeful, that with additional funding, we will be able to continue along this promising path, and continue researching the potential applications of a combination of ribavirin and tiazofurin in the treatment of MS." Source: Medical News Today � 2009 MediLexicon International Ltd (03/07/09)

Chronic cerebrospinal venous insufficiency (CCSVI) a new model of Multiple Sclerosis

Fri, 03 Jul 2009 08:28:00 EST

Background: The extracranial venous outflow routes in clinically defined multiple sclerosis (CDMS) have not previously been investigated. Methods: Sixty-five patients affected by CDMS, and 235 controls composed, respectively, of healthy subjects, healthy subjects older than CDMS patients, patients affected by other neurological diseases and older controls not affected by neurological diseases but scheduled for venography (HAV-C) blindly underwent a combined transcranial and extracranial colour-Doppler high-resolution examination (TCCS-ECD) aimed at detecting at least two of five parameters of anomalous venous outflow. According to the TCCS-ECD screening, patients and HAV-C further underwent selective venography of the azygous and jugular venous system with venous pressure measurement. Results: CDMS and TCCS-ECD venous outflow anomalies were dramatically associated (OR 43, 95% CI 29 to 65, p<0.0001). Subsequently, venography demonstrated in CDMS, and not in controls, the presence of multiple severe extracranial stenosis, affecting the principal cerebrospinal venous segments; this provides a picture of chronic cerebrospinal venous insufficiency (CCSVI) with four different patterns of distribution of stenosis and substitute circle. Moreover, relapsing-remitting and secondary progressive courses were associated with CCSVI patterns significantly different from those of primary progressive (p<0.0001). Finally, the pressure gradient measured across the venous stenosies was slightly but significantly higher. Conclusion: CDMS is strongly associated with CCSVI, a scenario that has not previously been described, characterised by abnormal venous haemodynamics determined by extracranial multiple venous strictures of unknown origin. The location of venous obstructions plays a key role in determining the clinical course of the disease. P Zamboni,1 R Galeotti,1 E Menegatti,1 A M Malagoni,1 G Tacconi,1 S Dall'Ara,1 I Bartolomei,2 and F Salvi2 1 Vascular Diseases Center, University of Ferrara, Ferrara, Italy 2 Department of Neurology, Bellaria Hospital, Bologna, Italy Source: J Neurol Neurosurg Psychiatry. 2009 April; 80(4): 392-399. (03/07/09)

Multiple Sclerosis study offers theory for why repair of brain's wiring fails

Wed, 01 Jul 2009 12:53:00 EST

Scientists have uncovered new evidence suggesting that damage to nerve cells in people with multiple sclerosis accumulates because the body's natural mechanism for repair of the nerve coating called "myelin" stalls out. The study, published today, July 1, 2009, in the print edition of "Genes & Development," was conducted by scientists at the University of California, San Francisco and University of Cambridge. The research was led by co-senior investigator David Rowitch, MD, PhD, a Howard Hughes Medical Institute investigator at UCSF. The investigation, conducted in mice and in human tissue, showed that repair of nerve fibers is hampered by biochemical signals that inhibit the development of cells known as oligodendrocytes, which function as repair workers in the brain. Oligodendrocytes form a protective sheath, known as myelin, that insulates the fibrous cables, or axons, radiating from nerve cells. In multiple sclerosis, the immune system's T cells and B cells attack oligodendrocytes, ultimately damaging the myelin sheath to the point that the electrical signals transmitted by the axons beneath it are disrupted. Remarkably, the brain generally is able to recruit fresh, immature oligodendrocytes to the myelin sheath to repair the damage, for a time. This explains why, in the most common form of the disease, known as relapsing remitting MS, the symptoms -- which range from tingling and numbness in the limbs to loss of vision and paralysis -- disappear or are greatly reduced, for some times months or years at a time. Ultimately, however, the repair process falters and the disease progresses. In their study, the team set out to see if they could determine what was slowing down myelin repair. They lesioned a small region of white matter in healthy mice, then monitored the repair process, examining the tissue after five, 10, and 14 days. ................. For the full report please go to MSRC: MS Research News : Myelin Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1845

Phase II trial Of Multiple-Sclerosis treatment CDP323 halted

Wed, 01 Jul 2009 06:28:00 EST

Biogen Idec Inc. and Belgian biopharmaceutical company UCB SA discontinued a Phase II clinical trial of a treatment for relapsing-remitting multiple sclerosis, saying there was no clinically relevant benefit for patients. The companies said a preliminary interim analysis showed patients enrolled in the clinical trial didn't benefit as expected from the treatment, CDP323, compared with placebo after a six-month treatment period. Source: Biogen Idec Inc. & UCB SA (01/07/09)

Important modulator of immune cell entry into the brain discovered

Tue, 30 Jun 2009 08:17:00 EST

Researchers in Berlin, Germany have ameliorated inflammation of the brain in mice caused by immune cells. A receptor they discovered on the surface of T cells in the central nervous system (CNS) plays the key role. The researchers showed that this bradykinin receptor 1 (B1) controls the infiltration of immune cells into the CNS. When they activated B1 in mice with encephalitis, they were able to slow down the crossing of the immune cells through the blood-brain-barrier into the CNS. As a result, the inflammation markedly decreased. ommenting on the findings, Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said, "This is a very important piece of research. We have long known that the crossing of immune cells into the CNS is a major problem in MS. This work shows that inflammation can be decreased and hopefully will lead to further research into prevention of the inflammatory response completely." The work by Dr. Ulf Schulze-Topphoff, Prof. Orhan Aktas, and Professor Frauke Zipp (Cecilie Vogt-Clinic, Charit� - Universit�tsmedizin Berlin, Max Delbr�ck Center for Molecular Medicine (MDC) Berlin-Buch and NeuroCure Research Center) together with researchers in Canada and the USA may unveil a new target for the treatment of chronic inflammatory diseases such as multiple sclerosis (MS) (Nature Medicine, doi 10.1038/nm.1980)*. It has been known for a long time that T cells can attack the body's own structures and, if they infiltrate the CNS, cause diseases such as multiple sclerosis (MS). The T cells damage the myelin sheath, the material that surrounds and protects the fibers of nerve cells. This damage slows down or blocks messages between the brain and the body, leading to various symptoms of MS such as impaired movements. The molecular analysis of damaged tissue from patients with MS led the researchers to the B1-receptor. The data they evaluated showed that two different pathways known to play a crucial role in the cardiovascular area also seem to play an important role in the CNS: namely, the renin-angiotensin-system, and the kallikrein-kinin-system, the latter of which the researchers in Berlin put their focus on...................................... For the full report please go to MSRC: MS Research News : New Discoveries : Antibodies, B Cells,T-Cell Activation and Immune Response - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1100

Biogen reports 10th Tysabri PML case

Mon, 29 Jun 2009 11:26:00 EST

Biogen Idec has reported that a tenth multiple sclerosis patient being treated with Tysabri was diagnosed with a serious brain infection. The latest case of progressive multifocal leukoencephalopathy (PML) occurred outside the U.S. in a patient on Tysabri therapy for 30 months. Four Tysabri patients on therapy for more than 30 months have now contracted PML, including the last three reported cases. This is raising concerns that the risk of a multiple sclerosis patient contracting PML increases with longer duration of Tysabri therapy. The overall incident rate of PML is still very small and Biogen Idec has presented scientific data disputing the notion that PML risk increases with longer Tysabri use. However, some doctors are beginning to cycle patients off Tysabri after two years or putting patients on drug holidays. If this trend continues, Tysabri patient and revenue growth -- already stunted -- could stall further. Source: The Street.com � 1996-2009 TheStreet.com, Inc.(29/06/09)

Enrollment complete in second Phase III laquinimod multiple sclerosis trial

Mon, 29 Jun 2009 04:33:00 EST

Teva Pharmaceutical Industries and Active Biotech have completed patient enrollment for the second pivotal Phase III clinical trial, Bravo, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis. Bravo is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod compared to placebo, and to provide risk-benefit data for laquinimod compared to a currently available injectable treatment, Avonex. The Bravo study completed patient enrollment in June 2009, recruiting more than 1,200 patients at 156 sites in the US, Europe, Israel and South Africa. Allegro, the first global Phase III trial of laquinimod, completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites in North America, Europe and Asia, said Teva. The trial is currently ongoing. Moshe Manor, Teva's group vice president of global branded products, said: "Teva and Active Biotech are encouraged by the potential of laquinimod to address patients' unmet need for an oral immunomodulating multiple sclerosis therapy that provides efficacy while maintaining safety. We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for relapsing-remitting multiple sclerosis patients." Source: Teva Pharmaceutical Industries and Active Biotech (29/06/09)

Disease-modifying drugs improve cognitive function in Multiple Sclerosis patients

Mon, 29 Jun 2009 03:32:00 EST

Patients with relapsing-remitting multiple sclerosis (RRMS) who receive glatiramer acetate (GA) or interferon (IFN) beta show a reduction in cognitive impairment and relative stability of cognitive and affective variables at 2 years, according to the results of an observational study presented at the 19th Meeting of the European Neurological Society (ENS). The aim of the observational study was to evaluate the long-term effects of first-line disease-modifying therapies with GA or IFN beta on cognitive functions, affective status, fatigue and quality of life in patients with RRMS (ITACA study). "A total of 752 patients with RRMS and a mean age of 36 years were enrolled in 79 Italian centres," explained principal investigator Monica Falautano, PhD, Functional Unit of Psychology, IRCCS H. San Raffaele Milano, Milan, Italy. Study patients were treated with either GA or IFN beta. At baseline and 6, 12, 18, and 24 months, a fatigue and physical disability evaluation was performed. Cognitive and affective assessments were performed at baseline and 12 and 24 months. A significant reduction [P < .0001] in cognitive impairment was observed at the 24-month follow-up, Dr. Falautano noted. At baseline, 40% of all patients showed mild cognitive impairment, and 16% showed severe cognitive impairment, which the researchers said was reduced to 30% and 11%, respectively, at 2 years. A higher proportion of GA than IFN patients had been affected by severe cognitive impairment (20% vs 12%). At the 24-month follow-up, the percentage of severe impairment was reduced to similar amounts in both treatment groups (12% and 10%, respectively). According to the mean Montgomery-Asberg Depression Rating Scale score, significant depressive symptoms were missing both at baseline and at the 24-month follow-up. Physical and mental health assessed with the Multiple Sclerosis Quality of Life 54 questionnaire correlated highly significantly at baseline and at the 24-month follow-up (P < .001). Patients did not report any changes in perception of their quality of life after 2 years of treatment. No changes were observed in Kurtzke's Functional Systems Scores. "The immunomodulatory treatment may have an impact on cognitive function," Dr. Falautano summarised the primary result of the study. "Nevertheless, a longer follow-up is advisable to confirm our results." Source: European Neurological Society (29/06/09)

Tysabri therapy significantly improves quality of life in patients with highly active relapsing MS

Fri, 26 Jun 2009 03:03:00 EST

According to a post hoc analysis presented at the 19th Meeting of the European Neurological Society (ENS), patients with highly active multiple sclerosis (MS) have significant improvement in their physical and mental quality of life (QOL) after 2 years of treatment with natalizumab. In the phase 3 Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study and the Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis (SENTINEL) study, natalizumab significantly improved QOL as measured by the Medical Outcomes Study Short Form-36 (SF-36) and a visual analogue scale (VAS) of well-being in patients with relapsing MS. In AFFIRM, patients received natalizumab or placebo for up to 116 weeks. In SENTINEL, treatment consisted of natalizumab added to interferon (IFN) beta-1a or placebo plus IFN beta-1a for up to 116 weeks. "We performed a post hoc analysis to assess QOL in the subgroup of patients with highly active disease," explained Robert Hyde, PhD, Biogen Idec, Inc., Cambridge, Massachusetts, on June 22. The researchers pooled data from AFFIRM and SENTINEL to evaluate the effects of natalizumab on QOL at 2 years in this patient group (n = 378)......................... For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : TYSABRI� Ongoing Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1768

Rapid beneficial effects of new Rebif(R) formulation on MRI outcomes in Multiple Sclerosis

Wed, 24 Jun 2009 10:41:00 EST

Patients with relapsing-remitting multiple sclerosis (RRMS) show early benefit from a new formulation of subcutaneous interferon (IFN) beta-1a as measured by magnetic resonance imaging (MRI), according to a study presented at the 19th Meeting of the European Neurological Society (ENS). Nicola De Stefano, MD, Department of Neurological and Behavioural Sciences, University of Siena, Siena, Italy, spoke on behalf of the researchers from the Study to Evaluate Rebif New Formulation (IFN-Beta-1a) in Relapsing Remitting Multiple Sclerosis (IMPROVE). The phase 3b double-blind, placebo-controlled, multicentre study evaluated the efficacy, safety, and tolerability of a new formulation of IFN beta-1a compared with placebo in patients with active RRMS. This new formulation is free from serum-derived products and has been developed with the aim of improving injection tolerability and reducing immunogenicity. In the double-blind phase, 180 patients were randomised to receive either the new formulation of IFN beta-1a 44 mcg 3 times weekly or placebo for 16 weeks. The primary endpoint was the number of combined unique active (CUA) brain lesions at week 16. Secondary endpoints included changes in T2 load and cumulative number of new gadolinium-enhancing and T2 lesions. "Every single MRI endpoint was significantly in favour of the active treatment," Dr. De Stefano summarised. At week 16, the number of CUA lesions was significantly lower with IFN beta-1a (0.9 vs 3.0 in the placebo group, P < .001). More than half of the patients (53.3 %) in the active-treatment group had no CUA lesions at week 16, compared with 16.7% in the placebo group. "A beneficial effect of the treatment can be seen even in a short period," Dr. De Stefano noted. "Post hoc analyses showed a significant effect already at 4 weeks." From week 4 on, the mean cumulative number of CUA lesions was significantly lower in the IFN beta-1a group, with a 41% reduction compared with the placebo group. The cumulative number of new gadolinium-enhancing and new T2 lesions was significantly reduced at 16 weeks (P <.001). At week 16, the change in T2 burden of disease was significantly lower with IFN beta-1a than placebo (P < .001). The most commonly reported adverse event was flulike illness (50% and 17% in the IFN and placebo groups, respectively). As Dr. De Stefano mentioned, a 24-week, single-arm, rater-blind treatment phase was initiated after the double-blind phase and has been completed recently, and the results will be presented soon. [Presentation title: Beneficial Effects of a New Formulation of Subcutaneous Interferon Beta-1a on Magnetic Resonance Imaging Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis: Results at 16 Weeks From a Double-Blind, Placebo-Controlled Study. Abstract P348] Source: Doctor's Guide (c) 1995-2009 Doctor's Guide Publishing Limited (24/06/09)

Cigarette smoking may lead to nerve damage and demyelination in the brain

Wed, 24 Jun 2009 09:45:00 EST

There may be a direct link between smoking cigarettes and brain damage, according to a new study from the Indian National Brain Research Center. Science Daily reports that researchers Debapriya Ghosh and Dr. Anirban Basu have found that a compound in tobacco provokes white blood cells in the central nervous system to attack healthy cells, leading to severe neurological damage. The compound, called NNK, is a chemical substance that becomes carcinogenic when it is altered by the metabolic processes of the body. NNK does not appear to harm brain cells directly, but it may cause neuroinflammation, a condition that leads to disorders such as Multiple Sclerosis. �Considering the extreme economical and disease burden of neuroinflammation-related disorders, it is extremely important from a medical, social, and economic point of view to discover if NNK in tobacco causes neuroinflammation� said Ghosh. The team conducted two types of tests�one outside of a living host in glass and one in laboratory mice. They used blot analysis techniques that showed that the introduction of NNK resulted in a clear increase in proinflammatory signaling proteins, proinflammatory effector proteins, and other stress-related proteins. They also found increased levels of proinflammatory cytokines, which act as molecular messengers between cells. This shows that NNK provokes an exaggerated response from the brain�s immune cells, known as microglia. These cells act as destroyers for the brain by attacking damaged or unhealthy cells. But when provoked by NNK, these cells start to attack healthy brain cells rather than the unhealthy ones they are supposed to attack. NNK is present in all forms of tobacco, so it can also enter the body through chewing. In addition, second-hand smoking may lead to the same neuroinflammation conditions because NNK is also present in the smoke itself. Smoke-filled air indoors may contain up to 26 nanograms of NNK, and concentrations of NNK in tobacco can vary from 20-310 nanograms. This means that both direct and second-hand smoking can lead to substantial measures of NNK intake. �This research sheds light on the processes that lead to nerve cell damage in those who smoke cigarettes or consume tobacco products on regular basis,� said Ghosh. Source: Everything Addiction Copyright 2009 Everything Addiction (24/06/09)

Santhera and NIH collaborate to evaluate Catena� in Primary Progressive Multiple Sclerosis

Wed, 24 Jun 2009 08:07:00 EST

Santhera Pharmaceuticals announced today a collaboration with the US National Institutes of Health (NIH) to investigate Catena� as potential treatment of Primary Progressive Multiple Sclerosis (PPMS). An estimated 150,000 to 300,000 patients worldwide suffer from this rare but devastating form of Multiple Sclerosis. The Phase I/II trial consists of a one-year observational and a two-year interventional period. The IPPoMS (Idebenone in Patients with Primary Progressive Multiple Sclerosis) trial is a Phase I/II study with a 12-month pre-treatment baseline period followed by a double-blind, randomized, placebo-controlled treatment of 24 months duration investigating the safety and efficacy of one dose of Catena� (INN: idebenone) versus placebo. During the baseline period up to 80 patients will be enrolled to collect patient-specific biomarkers of disease progression as well as longitudinal neuroimaging and clinical data. Selection of the primary outcome measure as well as potential adjustments of the sample size will be based on the analysis of data from pre-randomization baseline period for the first 30 patients. The adaptive trial design allows for the selection of the most sensitive measures of tissue destruction of the central nervous system as key outcome parameters. In addition, this specific design was selected to reduce the number of patients usually required for clinical studies in MS. The IPPoMS study is performed as collaboration between the US National Institute of Neurological Disorders and Stroke (NINDS) at the NIH and Santhera. Under the collaboration, the NIH will conduct the clinical trial while Santhera will supply study medication. Bibiana Bielekova, Chief of the Neuroimmunological Diseases Unit at the NINDS and principal investigator of the study, declared: "PPMS is a debilitating disease for which no effective treatment is approved. Lack of demonstrated efficacy of immunomodulatory or immunosuppressive treatments suggests that alternative mechanisms, such as mitochondrial dysfunction and oxidative damage may underlie development of clinical disability in these patients. Previous studies have suggested that idebenone can increase the cellular energy production in the mitochondria and protect cells from oxidative stress. By conducting this study, we want to investigate the drug's potential as first efficacious therapy to treat patients suffering from PPMS." Thomas Meier, Chief Scientific Officer of Santhera, commented: "We are very pleased to be collaborating with Dr. Bielekova and her colleagues at the NIH in this intervention study in PPMS. There is a compelling scientific rationale that suggests that Catena� may protect from neuronal damage in patients suffering from PPMS. This is based on the principal mode of action of Catena� as an ATP production modulator and powerful antioxidant which is generally considered as safe and well tolerated in the dose that the NIH will use in the IPPoMS-study." Catena� is a trademark of Santhera Pharmaceuticals. Source: Santhera Pharmaceuticals (24/06/09)

RebiSmart(TM), first electronic injection device for delivery of Multiple Sclerosis treatment Rebif(R), launched

Wed, 24 Jun 2009 07:45:00 EST

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the launch of the innovative individually adjustable electronic injection device RebiSmart(TM) for the self-administration of Rebif(R) (interferon beta-1a), the company's disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS). RebiSmart(TM) is the first device of its kind in this indication and was specifically designed for ease of handling and use. The unique features of RebiSmart(TM) also introduce the potential for improved treatment adherence, helping patients receive the full benefit from their treatment. RebiSmart(TM) is used with Rebif(R) multidose cartridges, each of which contains one week's worth of medicine. Interactive, on-screen instructions and signals guide patients through the injection process, individually adjustable comfort settings give patients more flexibility with injection duration and depth, helping minimize discomfort and pain. "Making injection more comfortable for the patient is important to ensure optimal treatment outcomes in multiple sclerosis," said Dr. Virginia Devonshire, Assistant Professor of Neurology at the University of British Columbia in Vancouver, Canada. "The first electronic injection device in MS is an innovative approach and could contribute to increasing patient adherence to therapy." RebiSmart(TM) is the first and only injection device in MS that records the date, time and dosage of each injection so that an accurate history of dosing can be viewed and discussed with the patient, allowing physicians to monitor and improve patient adherence to therapy. The dose history can be downloaded and viewed on a personal computer, thus also enabling the upload to patient registries in order to evaluate outcomes data in MS. "The introduction of RebiSmart(TM) underscores our commitment to continuous advancements in multiple sclerosis treatments, in this case providing patients with an easy-to-use and innovative delivery system," said Dr. Roberto Gradnik, Executive Vice President Commercial Europe at Merck Serono. "Patients and healthcare professionals were involved in the design of RebiSmart(TM), and their feedback was extremely valuable for developing an innovative device that really meets their needs." RebiSmart(TM) has been approved in Canada and the European Union. It was first launched in the United Kingdom and is also available in Canada now. Further launches will follow on a country-by-country basis. Two strengths of the multidose cartridge, 132 micrograms (three doses of 44 micrograms) and 66 micrograms (three doses of 22 micrograms), were approved by the European Medicines Agency (EMEA) in January 2009. RebiSmart(TM) also facilitates use by patients starting treatment through its automatic pre-programmed titration setting. In May 2009, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA, issued a positive opinion for the storage of the multidose cartridge at temperatures up to 25 degreesC for 2 weeks. Source: SOA World Magazine �1994-2008 SYS-CON Publications, Inc (24/06/09)

In pursuit of a happiness gene

Wed, 24 Jun 2009 04:45:00 EST

The pursuit of happiness characterises the human condition. But for those suffering from stress, money trouble or chronic illness, a positive outlook on life can be difficult to find. Now, a Tel Aviv University researcher says we should look to our genes. Prof. Yoram Barak of Tel Aviv University's Sackler School of Medicine is engaged in the "attempt to find the happiness gene, the genetic component of happiness," which may be 50% responsible for an optimistic outlook. The research is a collaboration between Tel Aviv University and its affiliated research hospital, the Chaim Sheba Medical Centre at Tel Hashomer, which is the largest hospital in Israel. Initial research findings have made Prof. Barak optimistic about their ability to succeed. "If something is genetic, it should have a large concordance among twins," he says. "And the twin studies we are looking at show that 50% of happiness is genetically determined." Prof. Barak is now working with Prof. Anat Achiron of the Sheba Medical Center to identify the specific genes that are associated with happiness. Dr. Barak's current findings in the hunt for the happiness gene were presented at The World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada in 2008, and most recently detailed in the journal Expert Review of Neurotherapeutics, April 2009. ...................... For the full report please go to MSRC: MS Research News : MS and Genetics Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1347

Continuous disease-modifying treatment without interruptions provides better long-term outcomes in Multiple Sclerosis

Wed, 24 Jun 2009 03:17:00 EST

Patients with multiple sclerosis (MS) who adhere to their treatment with interferon (IFN) beta-1a without interruption have lower relapse and progression rates than patients who do not adhere to their medication as regularly, said researchers at the 19th Meeting of the European Neurological Society (ENS). In the Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study, IFN beta-1a 22 or 44 mcg administered subcutaneously 3 times weekly proved effective in reducing relapses and delaying disability progression in patients with relapsing-remitting multiple sclerosis (RRMS) compared with placebo. After the initial 2-year double-blind phase, patients originally randomised to placebo were re-randomised to IFN beta-1a 22 or 44 mcg 3 times weekly for an additional 2 years. On study completion, all patients were offered the choice of continuing to receive blinded or open-label treatment during years 5 to 6. Beyond year 6, patients could continue on any or no disease-modifying drug. Data from the long-term follow-up (LTFU, up to 8 years) supported the efficacy of the treatment..........................

Biogen enrolls patients in new Multiple Sclerosis trial

Tue, 23 Jun 2009 03:28:00 EST

Biogen Idec has enrolled its first patient in a phase 3 trial for a potential multiple sclerosis treatment that, when compared with existing therapies, would reduce the number of injections patients must receive. The trial, called ADVANCE, will determine the efficacy and safety of Biogen�s drug target, called PEGylated interferon beta-1a, in reducing relapse rates in patients with multiple sclerosis (RMS). The global study will enroll more than 1,200 patients with RMS between the ages of 18 and 55. The study�s goal is to determine whether the drug reduces the annualized relapse rate in patients with RMS at one year. The study will also examine if, over time, the potential treatment can slow disease progression and lead to a decrease in the number of a certain kind of brain lesions commonly seen in MS patients. The treatment is a combination of Interferon beta-1a, which has been used successfully to treat MS for more than 10 years, and PEGylation, which can extend the amount of time a drug remains in a patient�s system. If the trial is successful, the treatment has the potential to reduce the frequency of treatment injections and provide patients with an effective and more convenient dosing option. Source: Boston Business Journal � 2009 American City Business Journals, Inc.(23/06/09)

New data from CLARITY study show rapid and sustained MS relapse reduction for Cladribine tablets

Mon, 22 Jun 2009 10:34:00 EST

The Effect of Short-course Oral Treatment With Cladribine Tablets on Annualized Relapse Rate was Significant as Early as 12 Weeks After Initiation of Treatment and Sustained Through to the 96 Weeks of the Study Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today new data from post-hoc analyses of the 2-year (96-week) placebo-controlled CLARITYa Phase III trial using Cladribine Tablets (Merck Serono's proprietary investigational oral formulation of cladribine) to treat patients with relapsing-remitting multiple sclerosis. These data show that short-course oral treatment with Cladribine Tablets resulted in rapid and sustained improvements in clinical and magnetic resonance imaging (MRI) outcomes, which were accompanied by rapid and sustained effects on blood-cell subtypes implicated in the pathogenesis of multiple sclerosis. The data will be presented at the 19th Meeting of the European Neurological Society (ENS) in Milan, Italy. (1,2,3,4) "The early impact on relapse reduction, together with the evidence for sustained benefits over 96 weeks as shown in the CLARITY study, support the short-course annual dosing regimen for Cladribine Tablets," said Prof. Giancarlo Comi, Professor of Neurology at the University Vita-Salute San Raffaele in Milan, Italy and an investigator for the CLARITY study. "Short-course oral treatment with Cladribine Tablets has the potential to make a meaningful difference in the lives of people with multiple sclerosis and their families." A total of 1,326 patients were randomized to one of three different arms of the CLARITY study, consisting of two different dose regimens of Cladribine Tablets or matching placebo tablets (1:1:1 ratio). Cladribine Tablets were given in two (low-dose regimen) or four (high-dose regimen) treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days (depending on patient weight), which means study patients took Cladribine Tablets for 8 to 20 days during the year. In the second year, two treatment courses were administered to all patient groups, meaning that patients took Cladribine Tablets for 8 to 10 days during the year................................................... For the full report please go to MSRC: MS Research News : Drugs : Cladribine (Mylinax) - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1629

Ninth case of PML reported in Tysabri patients with Multiple Sclerosis

Mon, 22 Jun 2009 03:28:00 EST

Biogen Idec Inc. reported that a ninth patient on its multiple sclerosis drug Tysabri, sold with Elan PLC, has developed a rare brain infection, the third such report since mid-May. A suspected link to progressive multifocal leukoencephalopathy, or PML, led to Tysabri being pulled from the market for 18 months beginning in 2005. Previously the company had reported that eight people had confirmed cases of PML, with one dying, since the relaunch. The most recent case was reported one week ago. The drug was allowed back on the market in 2006 because of its effectiveness in fighting the degenerative disease and the incidence of PML remains well below the long-projected risk of one in 1,000 patients developing the infection. "PML is still very rare in Tysabri-treated patients," said Biogen spokeswoman Shannon Altimari. The patient with the latest confirmed PML case took 34 doses of the monthly medication and was located overseas. Only two of the nine cases since last July were located in the U.S. Altimari said Biogen doesn't know why confirmed cases of the condition are more common overseas, but that the company is constantly performing research to better understand the infection. Much is unknown about PML, but it is thought to be caused when the JC virus, which most people carry, attacks the central nervous system in those with weakened immune systems, often leading to an irreversible decline in neurologic function and death........................... For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing News : TYSABRI� - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1905

Parent of origin effect in multiple sclerosis

Thu, 18 Jun 2009 04:52:00 EST

Background: Multiple sclerosis (MS) is a complex neurologic disease with a striking geographical distribution. In Canada, prevalence is high in Caucasians of Northern European ancestry and uncommon in North American Aboriginals, many of whom now have Caucasian admixture. Methods: The population-based Canadian Collaborative Project on the Genetic Susceptibility to MS provided the characteristics of 58 individuals with 1 Caucasian and 1 North American Aboriginal parent from a database of 30,000 MS index cases. Results: We found that MS index cases with a Caucasian mother and a North American Aboriginal father had a higher sib recurrence risk and greater F:M sex ratio (p = 0.043) than patients with a North American Aboriginal mother and Caucasian father. Conclusions: Maternal parent-of-origin effects in multiple sclerosis disease etiology previously seen in studies of half-siblings and avuncular pairs are also seen in Caucasian-North American Aboriginal admixture matings and warrant further investigation. A differential influence of maternal risk transmission on the sex ratio of affected offspring is implied. The method of analysis used may have broader implications for detection of parent-of-origin effects in admixture cohorts. S. V. Ramagopalan DPhil, I. M. Yee MSc, D. A. Dyment MD, DPhil, S.-M. Orton DPhil, R. A. Marrie MD, PhD, FRCPC, A. D. Sadovnick PhD, G. C. Ebers MD, FRCP, FRCPC, FMedSci*, For the Canadian Collaborative Study Group From the Wellcome Trust Centre for Human Genetics (S.V.R., D.A.D., S.-M.O., G.C.E.), University of Oxford, Headington; Department of Clinical Neurology (S.V.R., D.A.D., S.-M.O., G.C.E.), University of Oxford, John Radcliffe Hospital, Oxford, UK; Department of Medical Genetics (I.M.Y.) and Faculty of Medicine (A.D.S.), Division of Neurology, University of British Columbia, VCHA-UBC Hospital, Vancouver; and University of Manitoba Health Sciences Centre (R.A.M.), Winnipeg, Canada. Source: Neurology � 2009 by AAN Enterprises, Inc. (18/06/09)

Cannabis damages DNA and may cause cancer, new test reveals

Wed, 17 Jun 2009 02:18:00 EST

Using a highly sensitive new test, scientists in Europe are reporting "convincing evidence" that marijuana smoke damages the genetic material DNA in ways that could increase the risk of cancer. Researchers note that toxic substances in tobacco smoke can damage DNA and increase the risk of lung and other cancers. However, there has been uncertainty over whether marijuana smoke has the same effect. Scientists are especially concerned about the toxicity of acetaldehyde, present in both tobacco and marijuana. However, it has been difficult to measure DNA damage from acetaldehyde with conventional tests. The research was carried out by Rajinder Singh, Jatinderpal Sandhu, Balvinder Kaur, Tina Juren, William P. Steward, Dan Segerback and Peter B. Farmer from the Cancer Biomarkers and Prevention Group, Department of Cancer Studies and Molecular Medicine and Karolinska Institute, Sweden. Raj Singh said: �Parts of the plant Cannabis sativa, also known as marijuana, ganja, and various street names, are commonly smoked as a recreational drug, although its use for such purposes is illegal in many countries. The scientists describe development and use of a modified mass spectrometry method that showed clear indications that marijuana smoke damages DNA. �There have been many studies on the toxicity of tobacco smoke. It is known that tobacco smoke contains 4000 chemicals of which 60 are classed as carcinogens. Cannabis in contrast has not been so well studied. It is less combustible than tobacco and is often mixed with tobacco in use. Cannabis smoke contains 400 compounds including 60 cannabinoids. However, because of its lower combustibility it contains 50% more carcinogenic polycyclic aromatic hydrocarbons including naphthalene, benzanthracene, and benzopyrene, than tobacco smoke.� The authors added: �It is well known that toxic substances in tobacco smoke can damage DNA and increase the risk of lung and other cancers. Scientists were unsure though whether cannabis smoke would have the same effect. Our research has focused on the toxicity of acetaldehyde, which is present in both tobacco and cannabis.� The researchers add that the ability of cannabis smoke to damage DNA has significant human health implications especially as users tend to inhale more deeply than cigarette smokers, which increases respiratory burden. "The smoking of 3-4 cannabis cigarettes a day is associated with the same degree of damage to bronchial mucus membranes as 20 or more tobacco cigarettes a day," the team adds. "In conclusion, these results provide evidence for the DNA damaging potential of cannabis [marijuana] smoke, implying that the consumption of cannabis cigarettes may be detrimental to human health with the possibility to initiate cancer development," the article states. "The data obtained from this study suggesting the DNA damaging potential of cannabis smoke highlight the need for stringent regulation of the consumption of cannabis cigarettes, thus limiting the development of adverse health effects such as cancer." Journal reference: 1.Singh et al. Evaluation of the DNA Damaging Potential of Cannabis Cigarette Smoke by the Determination of Acetaldehyde Derived N2-Ethyl-2′-deoxyguanosine Adducts. Chemical Research in Toxicology, 2009; 22 (6): 1181 DOI: 10.1021/tx900106y. Source: Science Daily � 1995-2009 ScienceDaily LLC (17/06/09)

Long-term study determines early predictors of response to Interferon Beta-1a in patients with MS

Tue, 16 Jun 2009 02:30:00 EST

In patients with relapsing-remitting multiple sclerosis (MS), progression of disability and higher relapse rates are early markers of long-term disease severity, while initiation of treatment with intramuscular interferon (IFN) beta-1a can delay this progression when initiated in patients with low disease burden, new findings suggest. Richard Rudick, MD, director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic Foundation, in Ohio, presented the results here at the Consortium of Multiple Sclerosis Centers (CMSC) 23rd Annual Meeting in a poster session. Previous data from the National Institutes of Health-funded Multiple Sclerosis Collaborative Research Group (MSCRG) indicated that intramuscular IFN beta-1a decreased relapse frequency and slowed disability over 2 years, the researchers note. The current study assessed data from a 15-year follow-up of that study to identify early markers of long-term response to therapy in the MSCRG study population. A strong relationship between magnetic resonance imaging (MRI) activity during the first 2 years of the MSCRG study and long-term Expanded Disability Status Scale (EDSS) progression at 15 years was evident in patients who received intramuscular IFN beta-1a, but this association was not observed with patients who received placebo..................... For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : AVONEX� and REBIF� - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1765

Researchers piece together more of the Multiple Sclerosis genetic code

Mon, 15 Jun 2009 09:06:00 EST

Australian and New Zealand scientists are a step closer to unravelling what causes multiple sclerosis. The researchers have pinpointed two regions in the human genome which contain genes that increase a person's risk of developing the debilitating autoimmune disease. The scientists say this may lead, eventually to being able to prevent people developing MS. Commenting on the study, Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said, "This research marks a milestone in the genetic understanding of MS. To have identified two parts of the human genome that show they have a role to play in the susceptibility of MS is a big step in the right direction for potential interventions in the disease's development." It's a mystery why multiple sclerosis strikes healthy people when they're aged around 30, attacking the nervous system and leading to a range of disabilities including blindness and paralysis. Scientists know genetics play a part but it's extraordinarily complex. After scanning the DNA of more than 5,000 people, researchers from Australia and New Zealand have now identified two regions in the human genome which contain genes which increase a person's risk of developing the disease. The research was coordinated by Dr Justin Rubio from the Howard Florey Institute in Melbourne. "The increased risk for each gene is about 20 per cent. It seems though that together if you carry both of these genes that you are probably maybe 150 per cent more likely to get MS.", said Dr Rubio. But just because a person has those genes, doesn't necessarily mean they will develop MS. Other factors, like viruses or environmental influences, are believed to play a part. For a while scientists have observed that people with a vitamin D deficiency are more prone to developing MS......................... For the full report please go to MSRC: MS Research News : MS and Genetics Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1347

Prevalence of multiple sclerosis in the United Kingdom - study estimates now 100,000 people with MS in UK.

Fri, 12 Jun 2009 10:29:00 EST

Sara L Thomas,a Rachael Williams,b Tim Williams,b Andrew J Hall.a a Department of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine b The General Practice Research Database Background Estimates from a decade ago suggested that 85,000 individuals were living with an MS diagnosis in the UK, but the accuracy of this figure is unclear. We analysed UK population‐based data to obtain updated estimates of the lifetime prevalence of MS and the number of individuals living with MS. Methods We analysed anonymised electronic medical records from the General Practice Research Database (GPRD), which covers approximately 6% of the UK population. We identified all patients registered with a GPRD practice between 2000 and 2008 with a �definite MS� diagnostic code anywhere in their medical record. Prevalence of MS was calculated as the proportion of the total GPRD population who had ever had an MS diagnosis, stratified by age, sex, geographical region and calendar year. Numbers for 2007 were scaled up to the 2007 UK population, using data from the Office for National Statistics. Estimates were adjusted for possible misdiagnosis/miscoding of MS in the GPRD, using 1) a positive predictive value (PPV) of 82% for MS diagnostic codes, ascertained in a previous GPRD validation study, and 2) the proportion of MS patients who had evidence of neurologist referral and/or hospital feedback. Analyses were repeated among individuals registered with a practice for ≥1 year, to account for delayed reporting of historical MS diagnoses by practices. Results Crude annual prevalence of MS increased from 17.2/104 (95% CI:16.7‐17.7) in 2000 to 19.8/104 (95% CI:19.3‐20.3) in 2008. In 2007, prevalence was 28.1/104 (95% CI:27.3‐28.9) among females and 10.8/104 (95% CI:10.3‐11.3) among males, and was highest among those aged 55‐64 years. Marked geographical variation was seen, with highest prevalence in 2007 in the Scottish Highlands/Islands (49.7/104, 95% CI:31.8‐73.9) and lowest in Greater Glasgow/Clyde (12.8/104, 95% CI:8.8‐18.1). After applying the percentage of male (72%) and female (75%) patients with neurologist referral/hospital feedback, the estimated number of individuals living with an MS diagnosis in 2007 was 88,760 (range:85,820‐91,770). Using a PPV of 82% for an MS diagnostic code, the estimated number of individuals living with MS was 98,110 (range:94,820‐101,450). Estimates were slightly higher when the 2007 GPRD population was restricted to those with ≥1 year�s follow‐up. Conclusion This analysis provides updated estimates for the number of people living with MS in the UK. The apparent increase in MS prevalence over time is likely to be due in part to increased ascertainment of MS cases and improved recording of MS diagnoses. Over‐estimation of the number of MS cases may have occurred, due to miscoding of tentative MS diagnoses as �definite MS� cases. Conversely, MS cases may have been underestimated, due to continuing under-ascertainment and under-recording of MS cases in general practice data, and to possible inaccuracies in the estimates of the PPV of an MS diagnostic code and the proportion of individuals with neurology referrals/hospital feedback. Future estimates of lifetime MS prevalence will be facilitated by ongoing improvements in general practice recording of diagnoses and by increasing data linkage between general practice and other medical records. Commenting on the study, Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said, � MSRC has been using a figure of 100,000 for the past 12 months. We have always believed the number of people with MS was higher than the very old 85,000 figure. It is good to see some further indication that this figure is much more likely to be accurate�

Tracking down the causes Of Multiple Sclerosis - new discoveries in immune response

Thu, 11 Jun 2009 04:14:00 EST

Over 100,000 people suffer from multiple sclerosis in Germany alone. Despite intensive research, the factors that trigger the disease and influence its progress remain unclear. Scientists from the Max Planck Institute of Neurobiology in Martinsried and an international research team have succeeded in attaining three important new insights into the disease. It would appear that B cells play an unexpected role in the spontaneous development of multiple sclerosis and that particularly aggressive T cells are activated by different proteins. Furthermore, a new animal model is helping the scientists to understand the emergence of the most common form of the disease in Germany. Multiple Sclerosis (MS) poses enormous problems for both patients and doctors: it is the most common inflammatory disease of the central nervous system in our part of the world and often strikes patients at a relatively young age. In some patients it leads to severe disability. Moreover, despite decades of research on MS, the causes and course of the disease are still largely unclear. There is much evidence to support the fact that MS is triggered by an autoimmune reaction: immune cells that should actually protect the body against threats like viruses, bacteria and tumours, attack the body's own brain tissue. New treatments now available can attenuate the harmful immune reaction and thus delay the progress of the disease. However, the more effective the treatment, the more serious its side effects. Therefore, it is a matter of extreme urgency that new forms of treatment be developed which can differentiate in a targeted way between the immune cells that cause the disease and those that should be protected. A better understanding of the disease is required in order to achieve this. Entirely new possibilities The research of multiple sclerosis has proven particularly difficult. This is due, not least, to the fact that the focus of the disease is embedded in the sensitive brain tissue and is, therefore, inaccessible. More than other branches of medicine, MS research is dependent, therefore, on animal models in its study of the disease. Working in collaboration with an international team, scientists at the Max Planck Institute of Neurobiology have succeeded in developing a very effective animal model. The specially bred mice spontaneously develop a disease pattern that is practically identical to the course of the human form of MS most common in our part of the world. Because the disease also develops spontaneously in humans, the new model is superior to all of the previous models which only develop MS symptoms following injection with brain tissue. Moreover, the research using the new model has already prompted a rather sensational discovery: the emergence of the disease requires significantly more immune cells than previously assumed...................... For the full report please go to MSRC: MS Research News : New Discoveries : Antibodies, B Cells,T-Cell Activation and Immune Response - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1100

Multiple sclerosis and EAE - are researchers barking up the wrong tree?

Thu, 11 Jun 2009 02:00:00 EST

Multiple sclerosis: looking beyond autoimmunity Introduction 'My dictionary gives the Latin root for falsity as fallere, which is the same root for the word failure.'-Lewis Thomas The chronic incurable disorder multiple sclerosis (MS) is characterized by neurodegeneration, multifocal demyelination and astroglial proliferation (gliosis). The prevalence of MS is influenced by geography and genetics. In the Western world it is a leading cause of neurological disability in the young. The cause and exact pathogenesis are still unknown. Some see MS as a T-cell-driven autoimmune inflammatory disease, targeting the myelin sheaths in the central nervous system, but there is no proof. Unlike autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus or myasthenia gravis, MS has no specific immunological marker. An animal model that has been used in MS research is experimental allergic encephalomyelitis (EAE), in which demyelination is induced by sensitization against myelin basic protein. Clinically and pathologically, however, EAE resembles acute disseminated encephalomyelitis (ADEM) rather than MS. Nonetheless, the EAE model has been used to drive the autoimmune theory and to develop treatments. An inflammatory hypothesis of demyelination also fails to explain various salient features of the disease (Box 1). Here, we explain our view that research and treatment strategy in MS need to change direction..................... For the full paper please go to MSRC: MS Research News - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=7

Stem cell transplant study shows promise for Multiple Sclerosis

Wed, 10 Jun 2009 05:59:00 EST

U.S. researchers have reversed multiple sclerosis symptoms in early stage patients by using bone marrow stem cell transplants to reset the immune system. Some 81 percent of patients in the early phase study showed signs of improvement with the treatment, which used chemotherapy to destroy the immune system, and injections of the patient's bone marrow cells taken beforehand to rebuild it. "We just start over with new cells from the stem cells," said Dr. Richard Burt of Northwestern University in Chicago, whose study appears in the journal Lancet Neurology. Multiple sclerosis occurs when the immune system mistakenly attacks the myelin sheath protecting nerve cells. It affects 2.5 million people globally and can cause mild illness in some people and permanent disability in others. Symptoms may include numbness or weakness in the limbs, loss of vision and an unsteady gait. "MS usually occurs in adults," Burt said in a telephone interview. Before they get the disease, their immune systems work well, he said, but something happens to make the immune system attack itself. His approach is aimed at turning back the clock to a time before the immune system began attacking itself. Burt said the approach -- called autologous non-myeloablative hematopoietic stem-cell transplantation -- is a bit gentler than the therapy used in cancer patients because rather than destroying the entire bone marrow, it attacks just the immune system component of the marrow, making it less toxic. Commenting on the study, Helen Yates, MSRC Chief Executive said, "This further piece of research into the use of stem cells with Multiple Sclerosis patients provides another piece of evidence that stem cells could one day provide clear therapies and treatments for MS. MSRC hopes that further work in this area proves as positive as this piece of research..........................." For the full report please go to MSRC: MS Research News : Stem Cell Research & Treatment : Multiple Sclerosis Specific Stem Cell Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1405

Breast-feeding beneficial for most mothers with MS

Tue, 09 Jun 2009 02:20:00 EST

New mothers with multiple sclerosis who want to breast-feed but worry it might cause their disease to relapse may be reassured by a new study that discovered this is not the case for most women. The study, in the June 8 issue of Archives of Neurology, found that almost two out of three women with multiple sclerosis (MS) who breast-fed exclusively for two months or more and who were not taking MS medications did not experience a relapse of their disease while they were breast-feeding. "The most important thing for patients and physicians to know is that there's no evidence that breast-feeding is harmful for women with MS," said study author Dr. Annette Langer-Gould, who was at Stanford University at the time of the study but is now a neurologist and research scientist with Kaiser Permanente Southern California in Pasadena. "If mothers decide to breast-feed and do what's best for baby, we couldn't see any evidence of risk, and it may even be better for mothers to breast-feed," she said. How breast-feeding might help suppress a relapse, despite a lack of medications, isn't clear. In people with MS, the body's immune system mistakenly attacks myelin, a substance that covers nerve fibers. Langer-Gould said that researchers have long known that women with MS often go into remission during pregnancy, which might indicate that hormones play some role in dampening the immune response that causes damage to the myelin. However, she said. the study's finding of continued MS remission during breast-feeding would suggest that pregnancy hormones, which decrease dramatically once the baby is delivered, cannot be the only reason for the suppression of MS. "Previous research has ignored the postpartum factor, and what our study suggests -- if these findings can be repeated -- is that it's probably a factor that's common to pregnancy and lactation," Langer-Gould said.................................. For the full report please go to MSRC: MS Research News : Pregnancy And MS Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1936

Battling MS in Baghdad: Iraqi doctor uses stem cell therapies to help treat patients� diseases

Mon, 08 Jun 2009 09:53:00 EST

Amid the blast walls and cacophony of Baghdad, patients at a local clinic are receiving potentially groundbreaking stem cell therapy, treatments that remain illegal and unproven in many countries. Dr. Abdul Majeed Alwan Hammadi is conducting the treatments for free, mostly on young Iraqis. He is a clinical hematologist who works in the Bone Marrow Transplant Center, part of Baghdad's Medical City complex of hospitals on the eastern banks of the Tigris River. Hammadi says he started therapies in 2008 and has so far treated 34 patients, the majority for multiple sclerosis. Unlike the more controversial embryonic stem cells, Hammadi's therapy uses a person's own adult stem cells, which researchers believe may contain various regenerative and adaptive properties that potentially hold the key to curing a number of diseases. Hammadi, who graduated from a medical college in Baghdad, claims no side effects have been reported in his patients. He said he is in the process of collecting his data for publication, while also seeking official license for the therapies from Iraq's Ministry of Health, which funds the center. One of Hammadi's patients and proponents of the therapy is the Rev. Andrew White, a British priest who runs St. George Church on Baghdad's Haifa Street. White was diagnosed with multiple sclerosis in 1998 and said his vision, speech and motor skills were steadily degenerating until he began Hammadi's therapy in January. White helped Hammadi establish the bone marrow center in Baghdad in 2001, bringing the doctor and his staff to England for training in marrow transplant techniques. White said his slurred speech and other MS symptoms improved since starting the three-hour therapy sessions, which involves Hammadi extracting adult stem cells from White's blood and then injecting them into his spinal cord......................................... For the full story please go to MSRC: MS Research News : Stem Cell Research & Treatment : Stem Cell Treatment - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1375

New studies show Vitamin D deficiency could cause Multiple Sclerosis in children

Mon, 08 Jun 2009 06:31:00 EST

Children who develop multiple sclerosis have substantially lower levels of vitamin D than children who do not develop the disease, according to a series of studies presented at an international conference on multiple sclerosis in Montreal. Multiple sclerosis is a degenerative disease of the nervous system in which the myelin sheath that insulates nerve cells breaks down, leading to problems in the transmission of nervous signals. Symptoms can range from tingling and numbness to tremors, paralysis or blindness. An estimated 2.5 million people around the world suffer from the disease, which is rarely diagnosed before the age of 15. In one study, researchers from the University of Toronto tested the vitamin D blood levels of 125 children who had exhibited symptoms indicating some form of damage to the myelin sheath. "Three-quarters of our subjects were below the optimal levels for vitamin D," lead researcher Heather Hanwell said. After a year, the researchers compared the data from the 20 children who had since been diagnosed with multiple sclerosis with those who had not exhibited any further demyelinating symptoms. They found that the average vitamin D levels of children who had been diagnosed with multiple sclerosis were substantially lower than those of the other children. Among the diagnosed children, 68 percent of children were actually deficient in the vitamin. A similar study was conducted by researchers from Toronto's Hospital for Sick Children. "Seventeen of 19 children who had been diagnosed with MS had vitamin D levels below the target level," researcher Brenda Banwell said. Researchers have suspected a connection between vitamin D and multiple sclerosis for many years, ever since discovering that the disease is more common at more northern latitudes. Because the body synthesizes vitamin D upon exposure to sunlight, deficiency is much more common in places where the sun is weaker, especially during the winter. "There is a very consistent pattern of latitude and multiple sclerosis," said epidemiologist and multiple sclerosis researcher Cedric Garland of the University of California-San Diego. Hanwell directly linked Canada's northern latitude to its high rates of multiple sclerosis. "In Canada for six months of the year the sun is not intense enough for us to manufacture vitamin D in our skin," she said. Canada has one of the highest multiple sclerosis rates in the world. One of the few countries with a higher rate is Scotland, which has regions reached by only a quarter of all available sunlight. Recent research has confirmed a strong connection in Scotland between vitamin D deficiency and poor health status. "People have been looking for things in the environment that might account for why Canada has such a high MS risk, and this is one of those factors," Banwell said.................... For the full report please go to MSRC: MS Research News : Vitamin D Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1334

A new lead for autoimmune disease

Fri, 05 Jun 2009 04:41:00 EST

A drug derived from the hydrangea root, used for centuries in traditional Chinese medicine, shows promise in treating autoimmune disorders, report researchers from the Program in Cellular and Molecular Medicine and the Immune Disease Institute at Children's Hospital Boston (PCMM/IDI), along with the Harvard School of Dental Medicine. In the June 5 edition of Science, they show that a small-molecule compound known as inhibits the development of Th17 cells, immune cells recently recognized as important players in autoimmune disease, without altering other kinds of T cells involved in normal immune function. They further demonstrate that halofuginone reduces disease pathology in a mouse model of autoimmunity. Currently there is no good treatment for autoimmune disorders; the challenge has been suppressing inflammatory attacks by the immune system on body tissues without generally suppressing immune function (thereby increasing risk of infections). The main treatment is antibodies that neutralize cytokines, chemical messengers produced by T cells that regulate immune function and inflammatory responses. However, antibodies are expensive, must be given intravenously and don't address the root cause of disease, simply sopping up cytokines rather than stopping their production; patients must therefore receive frequent intravenous infusions to keep inflammation in check. Powerful immune-suppressing drugs are sometimes used as a last resort, but patients are left at risk for life-threatening infections and other serious side effects. Through a series of experiments, the researchers show that halofuginone prevents the development of Th17 cells in both mice and humans, halts the disease process they trigger, and is selective in its effects. It also has the potential to be taken orally. "This is really the first description of a small molecule that interferes with autoimmune pathology but is not a general immune suppressant," says Mark Sundrud, PhD, of the PCMM/IDI, the study's first author. Recognized only since 2006, Th17 cells have been implicated in a variety of autoimmune disorders including inflammatory bowel disease, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, eczema and psoriasis. They are genetically distinct from the other major categories of T-cells (Th1, Th2 and T-regulatory cells). Th17 cells normally differentiate from "na�ve" CD4+ T cells, but when Sundrud and colleagues cultured mouse CD4+ T-cells along with cytokines that normally induce Th17 development, there was a pronounced decrease in Th17 cells -- but not in Th1, Th2 or T regulatory cells -- when halofuginone was added. Similarly, in cultured human CD4+ T-cells, halofuginone selectively suppressed production of IL-17, the principal cytokine made by Th17 cells. And in mice with experimental autoimmune encephalitis (EAE), an artificially-induced immune disease resembling multiple sclerosis in humans, and marked by infiltration of Th17 cells into the central nervous system, low-dose halofuginone treatment significantly reduced both the development of EAE and its severity. (In mice with another form of EAE that doesn't involve Th17 cells, halofuginone had no effect....................) For the full report please go to MSRC: MS Research News : Drugs : Further Possible MS Drugs and Treatments - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1397

Final appeal for help with multiple sclerosis study in Scottish islands

Thu, 04 Jun 2009 04:48:00 EST

Scientists conducting a major study into multiple sclerosis in Shetland and Orkney are making a final appeal for volunteers to help them complete their work. Study leader Jim Wilson, who is based at Edinburgh University, said there had been a "great" response both from those with the disease and those without, but he and his team required some more participants in the latter category. In particular, they would like females aged between 39 and 51 with one parent from Shetland and one parent from Scotland; females aged between 51 and 63 with one parent from the South Mainland and one parent from the West Mainland; males aged between 60 and 72 with one parent from Scotland and one parent from Shetland; females aged between 47 and 59 with one parent from Shetland and one parent from Scotland; and females aged between 34 and 46 with one parent from Shetland and one parent from Scotland. The study is attempting to find out why Shetland and Orkney have the highest prevalence of MS in the world. Dr Wilson hopes to find a new gene which influences the risk of developing the disease. A new MS susceptibility gene was recently discovered in the isolated population of Ostrobothnia in Finland using the exact same approach as is being taken in the Northern Isles. It is unlikely to be the same gene in Finland and Shetland. He said: "The basis of the study is to compare the DNA of the patients with that of the controls to see if it is possible to identify a gene that differs between them. To do this correctly the controls have to match the cases in terms of sex, age and where their family originates - the North Isles, part of the Mainland, etc. "In spite of large numbers coming forward as controls, there are still a few patients for whom we do not have a good match and I would like to ask anyone who matches the criteria above but does not have MS among their immediate family to volunteer. "Being a control involves one visit by Elizabeth Visser, our clinical research fellow, who will provide information about the study, go through a questionnaire to exclude symptoms of MS and then take a small blood sample to allow us to analyse the DNA......................................." For the full report please go to MSRC: MS Research News : MS and Genetics Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1347

Genzyme assumes primary responsibility for alemtuzumab in Multiple Sclerosis

Tue, 02 Jun 2009 09:37:00 EST

Genzyme Corp. announced that it has completed the transaction with Bayer HealthCare to acquire the worldwide rights to Campath�/MabCampath� (alemtuzumab), giving Genzyme primary responsibility for the development and commercialisation of this promising multiple sclerosis (MS) therapeutic candidate. Genzyme is conducting two rapidly progressing phase 3 studies of alemtuzumab in relapsing-remitting MS patients. "Alemtuzumab for multiple sclerosis is a potential significant therapeutic advance for patients, and we are pleased to be leading this program that we expect will provide an important catalyst for the company�s long-term growth.� Under the terms of the transaction, Genzyme will make no upfront payment to Bayer. In exchange for the rights to alemtuzumab, Genzyme will make payments to Bayer following product approval under an earn-out arrangement that is based on product revenue. Similarly, in exchange for the rights to Campath, Genzyme will make future payments based upon revenue. MS Development Genzyme is now leading the development program for alemtuzumab in MS, and following approval, will have primary responsibility for its commercialization. Alemtuzumab in MS is in two phase 3 trials. The first trial, for which enrollment is complete, treats early, active relapsing-remitting patients who have received no prior therapy. The second study, which is expected to complete enrollment before the end of this year, is studying relapsing-remitting patients who had active disease while on other MS therapies. Data from the trials are expected to be available in 2011, and approval is anticipated in 2012. Bayer, which has been co-developing alemtuzumab in MS with Genzyme, will continue to fund development at current levels until the investigational compound is approved for this indication. Source: Genzyme Corp. (02/06/09)

Low dose naltrexone: The next miracle drug?

Mon, 01 Jun 2009 05:36:00 EST

Naltrexone is the generic name for a drug, approved by the FDA in 1984, used to treat alcohol and opioid addiction. Opioids are generally pain-management agents such as morphine, codeine, oxycodone, and fentanyl. Opioids also include heroin and methadone, as well as our own naturally occurring endorphins. Endorphins are a type of neurotransmitter, released when we are subject to pain or stress, which have the effect of reducing these sensations. More than that, endorphins promote modulation of the appetite, release of sex hormones, feelings of euphoria, and enhancement of immune response. Some foods-such as chili peppers (the hotter the better) and chocolate-are said to promote endorphin release. Acupuncture, sex, massage, and exercise have also been shown to activate endorphin release. Naltrexone is an opiate receptor antagonist; that is, it blocks cellular opiate receptors. As such, it removes the pleasurable feelings associated with alcohol and opioid abuse. In fact, the drug does such a good job of blocking the receptors that many heroin addicts would stop taking naltrexone, since it simply made them feel terrible all the time. As such, methadone became the drug of choice in the treatment of heroin addiction. Neurologist Bernard Bihari MD, who at the time was treating heroin addicts with naltrexone, discovered that a substantial number of them-who also suffered from AIDS-had extremely low levels of endorphins. He postulated that this may have been the reason they turned to heroin in the first place. While opioid (and thus endorphin) receptors are found throughout the body, they are especially prevalent on immune system related cells....................... For the full article please go to MSRC: MS Research News : Drugs : Low Dose Naltrexone - Latest News

BioPartners GmbH withdraws its application for Biferonex

Mon, 01 Jun 2009 05:04:00 EST

The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw its application for Biferonex (interferon beta-1a), 6 million-international-unit solution for injection, prefilled syringes for subcutaneous administration. Biferonex was expected to be used to treat patients with relapsing-remitting MS. The application for the marketing authorisation for Biferonex was submitted to the Agency on 24 July 2007. On 19 February 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal. The company stated in its official letter that its decision to withdraw the application was based on the fact that the additional information provided in support of the re-examination had not changed the Committee's view on the benefit-risk balance of Biferonex. More information about Biferonex and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency's website after the next CHMP meeting of 22-25 June 2009. Source: Medical News Today � 2009 MediLexicon International Ltd (01/06/09)

Canine distemper virus and Multiple Sclerosis?

Mon, 01 Jun 2009 05:01:00 EST

Multiple sclerosis has been linked to several infectious organisms and the canine distemper virus is one of these organisms. Ongoing research could aid in curing MS. Multiple sclerosis (MS) in people is a neurological disease with an autoimmune component and a multifactorial cause. One recent theory discussed by Dr. JA Lincoln and his associates in the August, 2008 Neurol Clin proposes that adult exposure to an infectious organism could lead to an immune response which could subsequently cause symptoms of MS. They also theorize that exposure to these infectious agents early in life could lead to protection against multiple sclerosis later in life. The Link Between Canine Distemper Virus and Multiple Sclerosis Dr. Lincoln and his associates have examined the Epstein-Barr virus (EBV) and the canine distemper virus (CDV) as potential candidates for playing a part in the development of multiple sclerosis. Their epidemiologic data seem to support a link between both the EBV virus and the CDV virus and the development of clinical multiple sclerosis........................ For the full report please go to MSRC: MS Research News : Other Conditions : Epstein-Barr Virus

Multiple Sclerosis patients report greater treatment satisfaction with Tysabri

Mon, 01 Jun 2009 05:00:00 EST

Biogen Idec and Elan Corporation, plc have announced interim results from an ongoing, one-year longitudinal health-outcomes study in which patients reported significantly higher levels of treatment satisfaction after three infusions with TYSABRI� (natalizumab) when compared to multiple sclerosis (MS) therapies used previously. The findings from the study, which were reported by patients on therapy, further demonstrate the benefits of TYSABRI in treating MS and are helping to redefine successful treatment of the disease. The study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, is being presented in a poster today during the 23rd Annual Meeting of the Consortium of Multiple Sclerosis Centers. "The patients in this study reported significantly greater satisfaction with TYSABRI when compared to their previous MS treatments, which makes these data even more compelling for patients who may not be satisfied with their current treatment," said William Stuart, M.D., medical director of the Multiple Sclerosis Center of Atlanta. "When coupled with previously reported data from this ongoing study that showed overall improvement in quality of life measures, we have a clearer picture of the real-world impact of TYSABRI on MS patients' lives. The success of TYSABRI over the past three years should be an encouragement to move this drug to the forefront of treatment options in many select MS patients............................." For the complete report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : TYSABRI� Ongoing Research

Statins may have a negative impact in Multiple Sclerosis (MS) patients

Fri, 29 May 2009 20:00:00 EST

Statins, a commonly prescribed class of drugs used by millions worldwide to effectively lower blood cholesterol levels, may actually have a negative impact in Multiple Sclerosis (MS) patients treated with high daily dosages. A new study by researchers at the Montreal Neurological Institute (MNI), McGill University, demonstrates that statin therapy in mice inhibits myelin repair or remyelination in the central nervous system. The findings, published in The American Journal of Pathology, highlight the crucial need to monitor the effects of central nervous system-accessible immune therapies on the myelin repair processes in patients with MS and other progressive demyelinating diseases. Canadians have one of the highest rates of MS in the world. An estimated 50, 000 Canadians have MS, with approximately 1,000 new cases diagnosed each year. MS is an autoimmune disease of the central nervous system (CNS), in which immune cells attack the myelin sheath (the protective insulation of nerve fibres), and the myelin-producing cells of the CNS (oligodendrocytes), causing demyelination. This causes damage which disrupts the nerve cell's ability to transmit signals throughout the nervous system. In the early stages of MS, following an immune system attack on myelin, oligodendrocyte progenitor cells or stem cells in the CNS are recruited to the lesion. These cells mature and produce new myelin to repair the damage. "Statins, which are known to modify the immune system response and have a wide array of effects on other cellular processes, were propelled into clinical trials based on studies in an animal model of MS indicating a reduction in clinical disease severity," says Dr. Veronique Miron, post-doctoral fellow in Dr. Jack Antel's lab at the MNI, and lead investigator in the study. "The mechanism of statin action in these studies was not determined. That is, does statin directly effect myelin and/or the oligodendrocytes or is disease severity reduced indirectly due to the dampening of the immune response. This issue required further investigation, particularly due to the ability of statins to cross the blood-brain barrier and access the CNS, and the enrichment of cholesterol in the myelin sheath......................" For the full report please go to MSRC: MS Research News : Drugs : Statins

Diabetes drug may help those with Multiple Sclerosis

Fri, 29 May 2009 19:16:00 EST

U.S. medical researchers say they've found a drug used to treat diabetes shows protective effects in the brains of some multiple sclerosis patients. Researchers at the University of Illinois-Chicago College of Medicine say they conducted a small, double-blind clinical trial involving patients with relapsing remitting multiple sclerosis. The patients were assigned to take pioglitazone -- a type 2 diabetes drug commercially known as Actos -- or a placebo. Patients continued their normal course of therapy during the trial. The scientists said patients taking pioglitazone showed significantly less loss of grey matter during the course of the one-year trial than patients taking placebo. Of the 21 patients who finished the study, patients taking pioglitazone had no adverse reactions. "This is very encouraging," said Professor Douglas Feinstein. "Grey matter in the brain is the part that is rich in neurons. These preliminary results suggest the drug has important effects on neuronal survival." The scientists also tested pioglitazone in an animal model of MS and found the drug "can significantly reduce the clinical signs in mice with an MS-type disease," said Feinstein. "More importantly, when mice who are already ill are treated with pioglitazone, the clinical signs of the disease go away," he said. The study is reported in the online edition of the Journal of Neuroimmunology. Source: Media dis&dat (29/05/09)

GW Pharmaceuticals files Sativex� regulatory submission

Wed, 20 May 2009 05:14:00 EST

GW Pharmaceuticals plc announced that it has filed a regulatory submission for Sativex� for the treatment of spasticity due to Multiple Sclerosis. This submission follows the recent announcement of a positive Phase III trial in this indication. The regulatory submission has been filed in the UK and Spain under the European decentralised procedure. The UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as Reference Member State and has validated the application. It is expected that an outcome of the regulatory submission will be known towards the end of 2009 / early 2010. Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure. Sativex will be marketed in the UK by Bayer HealthCare, and in the rest of the European Union by Laboratorios Almirall S.A. Dr Stephen Wright, GW�s R&D Director, said, �We are pleased to have completed and filed the regulatory submission within a very short period of time of receiving the latest positive Phase III data. We look forward to working with the regulatory authorities in their review of the application.� Source: GW Pharmaceuticals plc (20/05/09)

Gordon Brown urged to commit millions for multiple sclerosis stem-cell research

Mon, 18 May 2009 03:40:00 EST

Prime Minister Gordon Brown has been urged to guarantee millions of pounds for research into stem-cell therapies for multiple sclerosis. The MS society said that without large-scale government support for clinical trials the new hope offered by stem-cell science may be lost. It wants to see a specific injection of �3 million to move stem-cell technology from laboratories to hospitals. Four years ago the government announced �50 million for stem-cell science. But since then, the MS Society said, little has been done to promote research into practical stem-cell treatments for conditions such as multiple sclerosis. Stem cells are immature cells that can develop along a number of different pathways. Scientists hope some of them may be used to create replacement neurons for brain and nervous system diseases. Source: news.scotsman.com All rights reserved �2009 Johnston Press Digital Publishing (18/05/09)

Tysabri will still play a significant role in second line relapsing-remitting MS

Wed, 13 May 2009 11:49:00 EST

Biogen Idec's Tysabri will play a significant role in the second line setting for the treatment of relapsing-remitting multiple sclerosis (MS), despite looming competition from new oral agents in development, neurologists told Pharmawire. The current standard of care in this setting includes Teva's Copaxone and the interferon drugs Avonex, Betaseron, and Rebif. Tysabri is also used in more advanced patients, who have failed on alternative therapies. Novantrone is a chemotherapy drug, which is also FDA approved to treat worsening relapsing MS or secondary progressive MS. Although patients may prefer these new oral pills over the current injectables, the leading orals in development - Novartis' FTY720 and Merck-Serono's cladribine - will likely face a risk management procedure (REMS) if approved, and may see slower than expected adoption in the real-world setting, specialists noted. Both cladribine and FTY720 were associated with significant toxicities over the current standard of care, and would likely only see approval with a risk management procedure, similar to what is currently being utilized with a currently marketed drug, Elan's Tysabri, neurologists noted. Some of these new oral agents will fail to gain approval and for those that do make it, there will be rigorous pharmacovigilence programs requested by the both the FDA and EMEA, according to Dr Hans Peter Hartung, professor and chairman of the department of neurology at University Hospital Dusseldorf, Germany. These agents will see slow uptake by the majority of neurologists because they will want to see how safety evolves in post-marketing studies, he explained. "Enthusiasm for these agents has been dampened," Hartung said. Tysabri, developed by Biogen and Elan, was withdrawn from the market in 2005, after patient reports of a rare, and potentially lethal brain inflammation known as PML, or progressive multifocal leukoencephalopathy. The drug was reintroduced to the market in 2006 under a REMS, the TOUCH program, in which patients are continuously monitored for PML. Recently, a sixth patient was diagnosed with PML......................................... For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing News : TYSABRI� - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1905

Chemical in cannabis may slow multiple sclerosis

Wed, 13 May 2009 04:50:00 EST

In lieu of curing a debilitating disease, the next best thing scientists can do is slow its progression and create better treatments. Armed with a $1.5 million National Institutes of Health grant, Temple researchers are studying more effective ways to treat multiple sclerosis. And their research utilizes synthetic cannabinoids based on chemicals derived from the marijuana plant. "A marijuana plant has about 96 different chemicals in it and you might immediately think about those that cause psychological effects," says researcher Ron F. Tuma, Stewart professor of physiology and associate professor of neurosurgery. "Instead, we're focusing on a chemical that doesn't cause psychoactive effects but does affect the immune system." Temple researchers Ron F. Tuma and Doina Ganea are studying more effective ways to treat multiple sclerosis using synthetic cannabinoids. Calming the immune system is key to fighting the disease. In multiple sclerosis, or MS, a person's immune system attacks the central nervous system. Current medications, like corticosteroids, turn off the immune response entirely, leaving an MS sufferer vulnerable to infection. "MS is a terrible disease and the more rapidly it progresses, the sooner it disables its victims," says co-researcher Doina Ganea, Earle H. Spaulding chair and professor of microbiology and immunology. "So, if you can slow that down for 10 or 20 years, you can make a significant impact on the patients' lives." Both the marijuana plant and the human body produce cannabinoids, which essentially act through specific receptors on immune cells regulating the immune response. Think of the receptors as "traffic cops" that tell the immune system when to turn on and off, so that the body knows when to fight an infection and when to stand down. But in the case of MS sufferers, those receptors are on alert, and the immune system is in constant attack mode. Tuma and Ganea theorized they could manipulate a man-made chemical to act as a cannabinoid and control the activation of those immune cells................ For the full report please go to MSRC: MS Research News : Drugs : Cannabis And Cannabinoid Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1815

Researchers identify pathway to reactivate myelin repair

Wed, 13 May 2009 01:49:00 EST

UMDNJ researchers have identified a key pathway that could lead to new therapies to repair nerve cells' protective coating stripped away as a result of autoimmune diseases such as Multiple Sclerosis (MS). An article reporting their findings will appear in the May 13 online edition of the Journal of Neuroscience. Myelin is fatty material that coats and protects the ends of nerve cells. The loss of myelin and myelin-producing cells impairs the ability of nerves to conduct signals. A severe loss may lead to erosion of nerve tissues and result in permanent damage. "In people with MS that is relapsing-remitting, the body can replace myelin that has been stripped away," explained Teresa L. Wood, Ph.D., the study's lead investigator. "But, after repeated attacks, that process of replacement no longer functions well," she added. "Our data demonstrate that a novel cellular pathway, called the mammalian target of rapamycin (mTOR), regulates the generation of new myelin-producing cells (oligodendrocytes) and the production of myelin in immature rodent cells," Wood said. She is a professor in the Department of Neurology & Neurosciences and the Rena Warshow Chair in Multiple Sclerosis at the UMDNJ-New Jersey Medical School. More work is needed to determine if the key to reactivate remyelination is to stimulate the pathway or if environmental impediments, such as inflammation, also must be overcome to allow the pathway to function normally. "Now at least we know a target to go after to promote repair," she said........................... For the full report please go to MSRC: MS Research News : Myelin Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1845

Positive results of stem cell transplantation to treat Multiple Sclerosis reported

Fri, 08 May 2009 10:36:00 EST

An article published in the Summer 2009 edition of Multiple Sclerosis Quarterly Report, a joint publication of United Spinal Association and the North American Research Committee on Multiple Sclerosis (NARCOMS), highlights the positive initial results of patients who have improving neurologic function after receiving a stem cell transplant, despite no longer taking any MS medications. The results are reported in a National Institutes of Health (NIH)-sponsored study called HALT-MS to confirm whether high-dose immunosuppression followed by autologous stem cell transplantation will prevent MS attacks in patients who are not responding to available treatment options and ultimately protect against the degeneration of nerve fibers. The article, written by George H. Kraft, MD, MS, director of the Western MS Center in Seattle, Washington, and colleagues, reveals the promising outcomes of the first three patients entered into the HALT-MS Study, including a 27-year-old woman with an 8-year history of relapsing MS who was treated with five different MS drugs, but continued to have relapses. The study involves wiping out the patient's immune system through high-dose chemotherapy or other means, such as radiation, to destroy most blood cells and bone marrow. Blood "stem cells" with the capacity to generate new blood and immune cells are then transplanted into the patient. These stem cells can either be the patient's own or those from a matched donor. Once the cells are transplanted, they repopulate the bone marrow and restart building all the cell types found in the blood, a process called "engraftment". After transplantation, the patient would effectively have a "new" immune system that would not attack nerves in the brain and spinal cord as seen in MS. Currently, there are approximately 400 patients with MS worldwide who have been treated with stem cell transplantation. Research demonstrates that patients with highly active forms of relapsing-remitting MS have responded best to treatment. The Halt-MS Study is taking place at four centers in the US: The Fred Hutchinson Cancer Research Center/University of Washington Western MS Center; Ohio State University; Baylor College of Medicine; and M.D. Anderson Cancer Center, and is currently open to participants with severe relapsing forms of MS. Source: United Spinal Association (08/05/09)

FDA accepts Fampridine-SR new drug application for filing

Thu, 07 May 2009 01:54:00 EST

Acorda Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009. The PDUFA date is the target date for the FDA to complete its review of the Fampridine-SR NDA. "I am pleased that we were able to work quickly to address the comments from the FDA and resubmit our NDA approximately three weeks from having received the Refuse to File letter on our initial NDA submission, and that the FDA accepted the filing less than two weeks later," said Ron Cohen, M.D., Acorda Therapeutics' President and CEO. "We are also encouraged that the FDA has elected to assign Priority Review status to the Fampridine-SR NDA." About Fampridine-SR Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation plc. Source: Acorda Therapeutics, Inc (07/05/09)

Incidence of PML with Tysabri in Multiple Sclerosis lower than previously thought

Wed, 06 May 2009 03:02:00 EST

The risk of developing progressive multifocal leukoencephalopathy (PML), a viral brain infection, in patients with multiple sclerosis (MS) taking the drug natalizumab (Tysabri) appears to be much lower - and the infection less deadly - than previously estimates, according to new postmarketing surveillance data. Previous research found that the risk of developing PML was 1 in 1000, but new data show that the risk is closer to 1.2 per 10,000 patients, according to Carmen Bozic, MD, vice president and global head of drug safety and risk management for the maker of natalizumab, Biogen Idec, in Cambridge, Massachusetts. Dr. Bozic delivered an updated overview of the risks and benefits of natalizumab during the American Academy of Neurology (AAN) 61st Annual Meeting. Approved In 40 Countries Natalizumab is approved in over 40 countries for the treatment of relapsing forms of MS to reduce the frequency of relapses and delay worsening of physical disability in patients who have had an inadequate response to or are unable to tolerate another MS medication. The drug is approved in the United States, Canada, Europe, Australia, and parts of the Middle East and Latin America. It is also approved in the United States to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease. Natalizumab is an antibody rather than an interferon; Biogen Idec also manufactures an interferon beta1-a drug (Avonex) for newly diagnosed MS patients. It works by preventing white blood cells from entering the brain and attacking nerves. The data presented were taken from the Tysabri Outreach: Unified Commitment to Health (TOUCH) prescribing program and the Tysabri Global Observation Program in Safety (TYGRIS), both part of a global risk-management program to further evaluate the safety of natalizumab. TOUCH is a mandatory prescribing program for all patients, physicians, and infusion centers in the United States that ensures "appropriate and informed use of natalizumab," the researchers note. TYGRIS is a global voluntary observational study evaluating the long-term safety of natalizumab in clinical practice. Data from countries that do not participate in either TOUCH or TYGRIS were also collected. As of the end of March 2009, or about 3 years after approval in the United States and the European Union, approximately 52,000 patients had been treated with natalizumab in the postmarketing setting. "This is more than 10 times the exposure we had in clinical trials," said Dr. Bozic. Long-Term Exposure As well, there is now much more information on the drug's long-term exposure in the postmarketing setting, she said. To date, about 24,900 patients have been taking the drug for 12 months or longer, 14,400 for 18 months or longer, and 6800 for 24 months or longer. Some patients have taken the drug for more than 2.5 years, she added. "So both overall exposure and long-term exposure is significantly greater than we had in the original clinical trials, and that gives us a very robust ability to evaluate the safety of the drug," she told Medscape Neurology & Neurosurgery. Of the 52,000 patients who have taken the drug, there have been 6 cases of PML, or an incidence of approximately 1.2 per 10,000 patients treated. "It's trending lower than what we saw in the clinical-trial setting," said Dr. Bozic. The 6 patients - 3 men and 3 women aged 37 to 59 years - had taken the drug as monotherapy for periods ranging from 12 to 31 months. "This is a highly variable duration of treatment," noted Dr. Bozic. No Patterns With PML Nothing seems to set these 6 patients apart from other MS patients, she noted. There was no pattern, for example, in terms of age - they were all about the same age as the MS population taking natalizumab - or their past health history. "We're actively engaged in research on PML to see if we can better understand specific risk factors for the disease; for example, whether there are specific host factors or specific viral factors," said Dr. Bozic. "But we don't have the answers on that yet; we're diligently working on it." Of the 6 patients, 5 are still alive. "That's good news," said Dr. Bozic. "The outcome of the patients in the postmarketing setting is looking better than what we saw in clinical trials from a survival perspective." While rare, PML is considered to be a highly fatal disease. Researchers also investigated whether the risk for PML increased with length of treatment, but "we haven't seen a clear-cut pattern to date," said Dr. Bozic. The incidence of PML in patients taking natalizumab for 1 year or more is 2.4 per 10,000 patients, 1.4 per 10,000 in patients treated for 18 months or more, and 3 per 10,000 in patients treated for 2 years or more, with confidence intervals "that are overlapping," said Dr. Bozic.............................. For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing News : TYSABRI� - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1905

Tysabri (Natalizumab) may activate Herpes viruses

Tue, 05 May 2009 10:14:00 EST

Oral herpes virus (HSV-1) eruptions were 3 times more likely in patients with multiple sclerosis who were taking natalizumab than in multiple sclerosis patients on no therapy, according to research presented at the American Academy of Neurology (AAN) 61st Annual Meeting. Nicoline Schiess, MD, Johns Hopkins Medical Center, Baltimore, Maryland, and colleagues evaluated the activity of various herpes viruses in 34 patients with multiple sclerosis taking natalizumab and 34 age- and gender-matched healthy controls, as well as 20 patients with multiple sclerosis on no therapy and 20 patients with multiple sclerosis on interferon therapy. All participants responded to a questionnaire regarding previous exposure and activation of herpes viruses: HSV-1 (oral), HSV-2 (genital), varicella zoster (VZV), and Epstein-Barr virus (EBV; indicating a history of infectious mononucleosis). Saliva and blood virus samples were collected in 12 patients and 10 healthy controls. Based on the questionnaire results, patients with multiple sclerosis were significantly more likely to report a history of infectious mononucleosis (EBV) (P = .05) and a history of genital herpes (HSV-2) than were healthy controls (P < .05). Natalizumab-treated patients were significantly more likely than healthy controls (P = .005) and untreated multiple sclerosis patients (P < .05) to develop oral herpes. Natalizumab-treated patients were less likely to report genital herpes, however, than were untreated MS patients (P < .05). In addition, natalizumab-treated patients were more likely than healthy controls to report an EBV recurrence (P = .05). There was no significant difference in the history of VZV or shingle recurrence in multiple sclerosis patients or healthy controls. Prior to natalizumab infusion, 6 of the 12 patients with multiple sclerosis had elevated VZV titres in their blood compared to 1 healthy control (P = NS). One week after the natalizumab infusion, VZV titres increased in the saliva, approaching statistical significance (P = .06). Patients with multiple sclerosis are more likely to report a history of infectious mononucleosis than healthy controls as well as a history of genital herpes, Dr. Schiess concluded. In addition, reactivation of herpes virus infections may occur with natalizumab treatment resulting in symptoms such as herpes labialis or mononucleosis. In addition, virus reactivation may be asymptomatic, but detectable in saliva, as was seen with VZV virus. Dr. Schiess plans to continue to study the pathophysiology of virus reactivation in the setting of treatment-induced immunosuppression. Source: Presentation title: Reactivation of Herpes Viruses in Multiple Sclerosis Patients on Natalizumab Therapy. Abstract P03.163 (05/05/09)

Epstein-Barr virus linked to Multiple Sclerosis

Tue, 05 May 2009 02:18:00 EST

Infection with Epstein-Barr virus appears to raise the risk of developing multiple sclerosis (MS), Boston researchers report. The findings offer the strongest evidence to date implicating the virus as a trigger for the chronic progressive autoimmune disorder of the brain and spinal cord that affects more than 350,000 Americans, says Lily Jung, MD, medical director of the neurology clinic at the Swedish Neurology Institute in Seattle. Jung was not involved in the study. Almost everyone is infected with Epstein-Barr virus (EBV) by the time they reach adulthood. Infection early in childhood typically does not cause severe illness, although infection that occurs in adolescence often leads to mononucleosis. Researchers have searched for decades for a viral or bacterial agent that may trigger MS in people who are genetically susceptible. Epidemiology professor Alberto Ascherio, MD, DrPH, and colleagues at the Harvard School of Public Health in Boston have published several studies suggesting that the Epstein-Barr virus may be that agent. The new study shows "that people who are not infected with Epstein-Barr virus do not get MS," Ascherio tells WebMD. "All 100% of people who got MS in our study were infected with Epstein-Barr virus," he says. The findings were presented at the annual meeting of the American Academy of Neurology........................... For the full report please go to MSRC: MS Research News : Other Conditions : Epstein-Barr Virus - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=707

Risk of Leukemia with Multiple Sclerosis drug higher than thought

Fri, 01 May 2009 06:08:00 EST

The risk of developing leukemia as a side effect of a drug for multiple sclerosis (MS) is higher than previously reported, according to a study presented as part of the Late-breaking Science Program at the American Academy of Neurology's 61st Annual Meeting in Seattle, April 25 - May 2, 2009. It is an immunosuppressant drug approved by the FDA for treatment of several forms of advancing MS. It is one of only two drugs that has been shown to benefit people with secondary progressive MS who are having attacks. However, the drug can cause heart damage at high total doses. Due to this, the lifetime cumulative dose is equal to about eight to 12 doses over two to three years. Previous studies have also shown that the people with MS treated with the drug have an increased risk of developing leukemia. Those studies showed that acute leukemia occurred in .07 percent to .25 percent of MS patients taking mitoxantrone. Today's retrospective study of 2,854 Italian people with MS receiving the drug found that leukemia occurred in .74 percent. "This rate is significantly higher than what has been previously reported," said study author Vittorio Martinelli, MD, of University Vita-Salute in Milan, Italy. "The potential risk of leukemia should be carefully considered against the potential benefits of mitoxantrone treatment on every single patient." The study participants all had at least one cycle of mitoxantrone treatment and were observed for at least one year. A total of 21 people developed leukemia, eight of whom died. The people who developed leukemia had more treatment cycles than those who did not develop leukemia -- 8.6 cycles versus 7.2 cycles. They also had a greater cumulative dose of mitoxantrone. The leukemia occurred an average of three years after the first use of the drug and an average of 18 months after the end of treatment. "It is vital that all MS patients treated with mitoxantrone undergo prolonged and careful hematological follow-up to check for acute leukemia," Martinelli said. Source: American Academy of Neurology (01/05/09)

Combination of drugs may relieve Multiple Sclerosis symptoms

Fri, 01 May 2009 04:57:00 EST

Adding steroid to multiple sclerosis treatment shows promise in study. Using a steroid drug in combination with a multiple sclerosis (MS) drug may give patients more relief from symptoms than using the MS drug alone, suggests a new study. In the study, which included 341 people with relapsing-remitting MS, some patients were randomly selected to receive the steroid drug methylprednisolone in three doses over three days once a month, in addition to regular treatment with the MS drug interferon beta-1a. Others received the interferon drug and a placebo. During the three-year study, the patients were assessed every three months. Those who took the steroid/interferon drug combination had 38 percent fewer relapses (episodes when the disease is active) than those who took the placebo and interferon, the study found. The patients in the steroid/interferon group also showed slight improvement on a test of MS disability, while those in the placebo/interferon group showed a slight decline. The Biogen Idec-supported study also found that MS-related brain lesions stayed the same size or shrank in the steroid/interferon group but grew larger in the placebo/interferon group. The findings were presented this week at the annual meeting of the American Academy of Neurology, in Seattle. "These results indicate that these two drugs may have a synergy when taken together and provide a more beneficial effect on the disease activity," study author Dr. Mads Ravnborg, of the Danish Multiple Sclerosis Research Center at Copenhagen University Hospital in Denmark, said in an American Academy of Neurology news release. "This is a promising finding, as the benefit from interferon is only moderate, and not everyone responds fully to the treatment, so anything we can do to boost those results is positive." Source: Bio-Medicine � 2003-2009 Bio-Medicine (01/05/09)

Grey matter under attack in Multiple Sclerosis

Fri, 01 May 2009 03:17:00 EST

Autoimmune disease is a condition in which the immune system attacks the body's own material just as aggressively as it would attack a foreign pathogen. Multiple sclerosis, MS for short, is just one such autoimmune disease, and is one of the most common neurological diseases in the 20 to 30 years age group. The disease can have very severe consequences for those afflicted, since the body's defenses attack the central nervous system. It has long been assumed that myelin is the most important target for the misdirected immune response. This white, fat-rich protective layer of specialized cells enshrouds the long extensions of neurons. However, the central nervous systems of MS patients also exhibit damage in the grey matter, where the nerve cell bodies are located. How the patient's disability develops depends greatly on the damage of the gray matter. An international group headed by medical scientist Professor Edgar Meinl of LMU Munich has now discovered a possible connection: The protein Contactin-2 is produced both in the myelin sheathing and by neurons in the grey matter - and is attacked by misdirected immune factors. "Our results suggest that these processes also play a role in MS patients," says Meinl. "It could even be that proteins existing both in myelin and in the grey matter are in fact the critical points of attack.............." For the full report please go to MSRC: MS Research News : New Discoveries : Brain Atrophy, Lesion Loads, White and Grey Matter - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1817

Research shows plasma exchange helps Multiple Sclerosis patients

Thu, 30 Apr 2009 10:54:00 EST

Researchers at Aurora St. Luke's Medical Center in Milwaukee report that plasma exchange therapy or PLEX dramatically improves the health of multiple sclerosis patients who fail to respond to conventional therapies. "There is no other treatment that brings about such a reversal in multiple sclerosis," says Bhupendra Khatri, M.D., the study's principal investigator and director of Aurora's Regional Multiple Sclerosis Center. "This treatment can turn lives around." Over 25 years, Dr. Khatri and his team followed 271 patients with chronic and progressive multiple sclerosis. These patients had not responded to drug therapy and were experiencing an increasing decline in their motor and verbal abilities. Patients received weekly plasma exchange treatments for 10 weeks, with the pace of plasma exchange therapy slowing over time or as their condition improved. Out of 271 patients, 217 or 80 percent, saw a long-term improvement in their disability. Unlike conventional multiple sclerosis treatments, such as chemotherapy drugs, which can have serious side effects such as heart damage or leukemia, the plasma exchange therapy was found to be safe, with no serious side effects. The study, "Sustained Long-Term Improvement in Disability with Plasma Exchange in Patients with Worsening Multiple Sclerosis: Results of a 25-Year Study," was presented at the American Academy of Neurology annual meeting in Seattle.................... For the full report please go to MSRC: MS Research News : New Discoveries : Plasma Exchange - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=2860

Tysabri patients reported to show overall improvement in cognition and quality of life, with lower levels of fatigue

Thu, 30 Apr 2009 06:42:00 EST

Biogen Idec and Elan Corporation, plc have announced results from an ongoing, one-year longitudinal health outcomes study (n=1275) in which patients who received three infusions of TYSABRI(R) (natalizumab) reported reduced fatigue, as well significant improvements in general and disease-specific measurements of quality of life (QoL) and cognitive function. Findings from the study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, are the first attempt to assess patient experiences with TYSABRI in usual-care settings. The results from this study are being presented today in two separate posters at the 61st Annual Meeting of the American Academy of Neurology. "MS is a debilitating disease that significantly reduces the quality of patients' lives. In this study, a majority of patients said they were less tired, thought more clearly, and had a better overall quality of life," said Dr. William Stuart, M.D., medical director of the Multiple Sclerosis Center of Atlanta. "Data from the pivotal trial has shown that TYSABRI not only results in a significant reduction in relapses, but also showed an improvement in quality of life. These new patient-reported outcomes expand our understanding of the real-world impact of TYSABRI on different aspects of the lives of MS patients." The ongoing one-year follow-up study will assess health outcomes from patients' perspectives before starting TYSABRI and after the third, sixth, and 12th infusions of TYSABRI, respectively. A majority of the patients in the study are female (78.4%) with mean age of 45.3 years and mean disease duration of 10 years...................... For the complete report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : TYSABRI� Ongoing Researc

Glutamate identified as predictor of disease progression in multiple sclerosis

Thu, 30 Apr 2009 04:50:00 EST

UCSF researchers have identified a correlation between higher levels of glutamate, which occurs naturally in the brain as a byproduct of metabolism, and greater disease burden in multiple sclerosis patients. The study is the first to measure glutamate toxicity in the brain over time and suggests an improved method for tracking the disease and predicting its course. The research team employed a novel technique, developed by Radhika Srinivasan, PhD, study author and assistant researcher in the UCSF Department of Radiology and Biomedical Imaging, to measure glutamate levels in clinical trial patients. The technique was based on a sophisticated form of imaging known as proton MR spectroscopy, which uses simple radio-frequency pulses targeting specific brain chemicals. Study findings were presented during the American Academy of Neurology annual scientific meeting in Seattle. Glutamate, a neurotransmitter, in normal levels performs fundamental processes like memory and sensory perception. In excess, it triggers a cascade of negative reactions in the brain leading to many of the complications associated with neurologic diseases such as MS, Parkinson's disease, stroke, ALS (amyotrophic lateral sclerosis or Lou Gehrig's disease) and Alzheimer's disease by destroying nerve cells and causing seizures, injury after stroke, and the perception of pain, among other problems. Already a target for therapeutic drug development, the identification of the glutamate pathway for MS suggests a new way for clinicians to monitor treatment of these drugs. "This is the first time that we have had the ability to measure glutamate toxicity in the brain in real time, which gives us a marker for monitoring disease progression as well as our treatment of the disease," said Daniel Pelletier, MD, study author, associate professor of neurology and a member of the Multiple Sclerosis Research Group at the University of California, San Francisco................. For the full report please go to MSRC: MS Research News : New Discoveries : Nerve and Brain Cell Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1398

Oral Multiple Sclerosis drug, Cladribine, appears effective, but cancer cases raise concerns

Thu, 30 Apr 2009 03:29:00 EST

Merck KGaA reported late-stage data showing that its cladribine tablets significantly cut the rate of clinical relapses, disability progression and brain lesions in patients suffering from relapsing remitting multiple sclerosis, echoing preliminary data reported earlier this year. But a handful of cancer cases in the study may raise some safety concerns for physicians that must choose cladribine over alternative therapies that have longer safety data in larger patient populations. Merck, based in Germany, is currently leading the race to bring an oral therapy to patients with the debilitating disease and plans to use the data to file for regulatory approval in Europe and the U.S. in mid-2009. Currently, the leading MS therapies sold by Biogen Idec Inc. are once-daily injections. "When you have the possibility to be first, you have the possibility to shape the market," said Elmar Schnee, head of Merck's pharmaceuticals business and member of its executive board, in an interview. In January, Merck reported that the company-run trial, involving 1,326 patients and lasting two years, met its primary goal of reducing the annualized relapse rate in comparison to placebo, cutting that rate by between 55% and 58% depending on the dosage. The full data, presented at the American Academy of Neurology meeting in Seattle, show that the relative relapse risk in cladribine was about half of that seen in patients on placebo. Over two years, 80% of the patients in the low-dose group and 79% of those in the high-dose group experienced no clinical relapse, compared to 61% of those on placebo. In another secondary goal of the trial, cladribine treatment cut the risk of disability progression by more than 30%. Both doses also reduced different types of brain lesions in MS patients, according to the study. Notably, four patients in the cladribine group developed cancer during the study and another case emerged six months after the study ended. One of the patients eventually died. There were no occurrences of cancer in the placebo arm......................... For the full report please go to MSRC: MS Research News : Drugs : Cladribine (Mylinax) - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1629

Tysabri may promote healing around nerves in Multiple Sclerosis

Wed, 29 Apr 2009 10:23:00 EST

Biogen Idec and its partner, Elan, catch a lot of heat because their fastest-growing drug for multiple sclerosis is associated with a rare, potentially fatal brain infection called PML. But today they are pushing back a bit with a study that suggests the drug may provide an important benefit to balance against the risk-the potential ability to help promote healing around the frayed nerves of MS patients. The finding is preliminary, from a small study of 62 patients who took natalizumab (Tysabri), and 26 patients in a control group followed for a year, according to research presented today at the American Academy of Neurology annual meeting in Seattle. Researchers at the Jacobs Neurological Institute in Buffalo, NY, led by Robert Zivadinov, found that natalizumab promoted re-myelination and stabilized de-myelination in lesions and brain tissue that appeared normal. If this can be proven in larger studies, it's the sort of finding that could change the risk/benefit equation for the drug. More than 400,000 people in the U.S. suffer from multiple sclerosis, a disease in which the immune system goes haywire and starts attacking the fatty coating around nerve fibers, called myelin. Existing MS drugs mostly work by tamping down the excess inflammation that that harms the myelin coating, but they don't really stop the short-circuiting of nerve signals that gradually robs people of their balance, and ability to walk. Scientists have not observed that older drugs work well enough to allow myelin to naturally regenerate, but that's one possibility for what was happening with patients in this study on natalizumab, says Al Sandrock, Biogen's senior vice president for neurology R&D. "It's hard to be absolutely sure you have re-myelination going on," Sandrock says. "Perhaps by decreasing inflammation you allow normal healing processes to take place..................." For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : TYSABRI� Ongoing Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1768

80-83 percent of patients taking multiple sclerosis drug FTY720 are relapse-free

Wed, 29 Apr 2009 06:22:00 EST

Novartis AG said a study shows that 80-83 percent of patients taking its multiple sclerosis drug FTY720 are relapse-free compared to 69 percent of those on the leading current treatment. Novartis, which is presenting new Phase III results to the American Academy of Neurology, said the data reinforces results announced in December that showed the annual relapse rate was 52 percent lower compared with patients taking Biogen's injectable multiple sclerosis drug Avonex. It said full results from the so-called TRANSFORMS study would be submitted to a peer-reviewed journal in the next few months, adding regulatory filings were on track for the United States and European Union at the end of 2009. Lead investigator Jeffrey Cohen said the trial showed that FTY720 "may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis". Novartis AG and Germany's Merck KGaA are leading the charge to develop MS drugs that can be taken orally, rather than by infusion or injection, but the firms must persuade physicians and investors that the treatments are safe. Novartis said serious adverse effects were reported in fewer than 2 percent of patients treated with FTY720 and said a role for the drug in the death of a patient in February could neither be confirmed nor ruled out. It added that the safety profile of a 0.5 mg dose appeared to be better than the 1.25 mg dose. "The results are statistically significant," said Vontobel analyst Andrew Weiss. "Somewhat comforting is the fact that no new safety concerns in the TRANSFORMS trial have emerged........." For the full report please go to MSRC: MS Research News : Drugs : FTY720 (Fingolimod) - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1309

High doses of vitamin D cut Multiple Sclerosis relapses

Wed, 29 Apr 2009 04:41:00 EST

High doses of vitamin D dramatically cut the relapse rate in people with multiple sclerosis, a study shows. Sixteen percent of 25 people with multiple sclerosis (MS) given an average of 14,000 international units (IU) of vitamin D a day for a year suffered relapses, says Jodie Burton, MD, a neurologist at the University of Toronto. In contrast, close to 40% of 24 MS patients who took an average of 1,000 IU a day -- the amount recommended by many MS specialists -- relapsed, she says. Also, people taking high-dose vitamin D suffered 41% fewer relapses than the year before the study began, compared with 17% of those taking typical doses. People taking high doses of vitamin D did not suffer any significant side effects, Burton tells WebMD. The findings were presented at the annual meeting of the American Academy of Neurology. In contrast to many vitamins, no recommended dietary allowance (RDA) has been established for vitamin D. Instead, the Institute of Medicine has set a so-called adequate intake level; the recommendations are 200 IU daily for people under 50, 400 IU daily for people 50 to 70, and 600 IU for those over 70. John Hooge, MD, an MS specialist at the University of British Columbia in Vancouver who was not involved with the research, says he recommends MS patients take at least 1,000 IU and "probably 2,000 IU" day. "This is an impressive study that shows that even higher doses are probably safe and even more effective. Maybe next year, I'll be recommending higher doses," he tells WebMD................. For the full report please go to MSRC: MS Research News : Vitamin D Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1334

New data demonstrates immunomodulatory effects of Laquinimod on Multiple Sclerosis disease activity

Wed, 29 Apr 2009 02:34:00 EST

Teva Pharmaceutical Industries Ltd. and Active Biotech announced results from several new clinical and preclinical studies providing further insight on the immunomodulatory mechanism of action (MOA) of laquinimod, a novel oral once-daily compound being developed for the treatment of relapsing-remitting multiple sclerosis (RRMS). Four sets of data being presented at the 61st Annual American Academy of Neurology Meeting (AAN) in Seattle stand to increase the understanding of how laquinimod may reduce multiple sclerosis activity and affect mechanisms related to disease pathology. Research looking at the mechanism by which the compound exerts its clinical effect is ongoing; Current available data indicate that laquinimod impacts RRMS by modulating key processes of the immune system, and suggest an immunomodulating effect within the central nervous system (CNS). "As we continue to study how laquinimod impacts multiple sclerosis, we remain encouraged by the potential of this oral candidate," explains Scott Zamvil, M.D., Associate Professor, Department of Neurology University of California, San Francisco, "Laquinimod, with a balanced safety and efficacy profile, may address a currently unmet medical need for patients seeking effective oral therapy for multiple sclerosis that is also well tolerated and safe." Laquinimod recently received Fast Track designation from the US Food and Drug Administration (FDA) which may allow the drug to enter the market as soon as late 2011. Teva completed enrollment for the first of its two Phase III clinical trials for laquinimod (ALLEGRO) in November 2008, and the second global Phase III study (BRAVO) is on schedule to complete patient enrollment in the first half of 2009............... For the full report please go to MSRC: MS Research News : Drugs : Laquinimod - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1735

Long-Term study with COPAXONE� indicated protective effect on brain tissue in Multiple Sclerosis patients

Tue, 28 Apr 2009 10:26:00 EST

New data presented at the 61st Annual Meeting of the American Academy of Neurology provided evidence that long-term treatment with Copaxone� (glatiramer acetate injection) may offer sustained protection from neuronal/axonal injury. This protective effect was reflected biologically by a significant increase in N-acetylaspartate (NAA), a specific marker of neuronal mitochondrial function, in treated versus non-treated relapsing-remitting multiple sclerosis (RRMS) patients. These six-year results augment previously published findings suggesting that treatment with Copaxone� may provide a neuroprotective effect in RRMS patients 1, 2. The study, "Six-Year Prospective Multi-Voxel Brain MRS Study of Two Cohorts in RRMS To Examine the Effect of Glatiramer Acetate on Neuronal/Axonal Metabolic Injury," is the largest (n=46) and longest study of its kind to date. In the study, patients taking Copaxone� for six years experienced an improvement in neuronal mitochodrial function, as quantified by an increase in neuronal NAA levels and evaluated by 1H- Magnetic Resonance Spectroscopy (1H-MRS). Decreased neuronal NAA levels are reflective of neuronal/axonal injury. "The potential ability to prevent or repair brain tissue damage in RRMS patients is an important treatment consideration given the degenerative pathology of this life-long condition," said Omar Khan, M.D., Professor of Neurology, Director, Multiple Sclerosis Center, Wayne State University and lead investigator of the study. "These data further substantiate our previous research into the potential neuroprotective effect of Copaxone�, as well as the use of NAA measures as a reliable marker for assessing a patient's disease progression and response to treatment................." For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : COPAXONE� Ongoing Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1767

'Good Cholesterol' May Help Decrease MS Inflammation, Lessen Disability

Tue, 28 Apr 2009 03:07:00 EST

Could HDL, the "good cholesterol," have the same protective effect in multiple sclerosis, an inflammatory disease of the brain's white matter, as it does in heart disease, through its anti-inflammatory effects on blood vessels? The answer may be yes, based on results of research conducted at the University at Buffalo and presented today (Tuesday, April 28) in a poster session at the American Association of Neurology meeting in Seattle, Wash. Allison S. Drake, MSc, a researcher in the Jacobs Neurological Institute (JNI), UB's Department of Neurology, is first author on the study. Bianca Weinstock-Guttman, M.D., UB associate professor of neurology and director of the JNI's Baird Multiple Sclerosis Center, initiated and oversaw the research. "We set out to evaluate the relationship between high-density lipoprotein (HDL) levels and disability in patients with MS," said Drake. "The protective effects of HDL in cardiovascular disease have been well established, but the role of HDL in MS had not been investigated. "We found that patients with greater disability (assessed using the physician-reported Expanded Disability Severity Score, EDSS) were more likely to have low HDL blood levels, while those with less disability had higher HDL levels," said Drake, "demonstrating a significant association between HDL level and disability............. For the full report please go to MSRC: MS Research News : New Discoveries : LDH - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=2857

Acorda Therapeutics resubmits new drug application for Fampridine-SR in Multiple Sclerosis

Mon, 27 Apr 2009 03:40:00 EST

Acorda Therapeutics, Inc. announced the resubmission of its New Drug Application (NDA) for Fampridine-SR to the U.S. Food and Drug Administration (FDA). Fampridine-SR is a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct "format issues" and requested additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, Acorda has resubmitted the Fampridine-SR NDA and believes that all of the Agency's comments related to the RTF have been addressed. Source: Medical News Today � 2009 MediLexicon International Ltd (27/04/09)

Stem cells from fat tissue offer hope for Multiple Sclerosis treatment

Fri, 24 Apr 2009 02:32:00 EST

A preliminary study on the use of stem cells obtained from a patient's own adipose tissue in the treatment of multiple sclerosis (MS) has shown promising results. The three case studies, described in BioMed Central's open access Journal of Translational Medicine, support further clinical evaluation of stromal vascular fraction (SVF) cells in MS and other autoimmune conditions. Thomas Ichim, from Medistem Inc., and Dr. Boris Minev, from the Division of Neurosurgery, University of California San Diego, worked with a team of researchers to demonstrate the possible effectiveness of SVF cells in MS treatment. Minev said, "All three patients in our study showed dramatic improvement in their condition after the course of SVF therapy. While obviously no conclusions in terms of therapeutic efficacy can be drawn from these reports, this first clinical use of fat stem cells for treatment of MS supports further investigations into this very simple and easily-implementable treatment methodology". MS is an autoimmune condition, in which the body's own defences attack nerve cells, resulting in loss of their fatty myelin sheath. The first symptoms usually occur in young adults, most commonly in women. It is believed that SVF cells, and other stem cells, may be able to treat the condition by limiting the immune reaction and promoting the growth of new myelin. According to Minev, "None of the presently available MS treatments selectively inhibit the immune attack against the nervous system, nor do they stimulate regeneration of previously damaged tissue. We've shown that SVF cells may fill this therapeutic gap". Minev and his colleagues provided the SVF treatment to three patients with MS. The first had suffered frequent painful seizures for the previous three years; after treatment he reported that the seizures had stopped completely and that he had seen significant improvements in his cognition and a reduction of spasticity in his arms and legs. The second patient reported improvements in his sense of balance and coordination, as well as an improved energy level and mood. The final patient had been diagnosed with MS in 1993. After SVF treatment in 2008, his gait, balance and coordination improved dramatically over a period of several weeks. According to Minev, "His condition continued to improve over the next few months and he is currently reporting a continuing improvement and ability to jog, run and even bicycle". Journal reference: Neil H Riordan, Thomas E Ichim, Wei-Ping Min, Hao Wang, Fabio Solano, Fabian Lara, Miguel Alfaro, Jeorge P Rodriguez, Robert J Harman, Amit N Patel, Michael P Murphy and Boris Minev. Non-Expanded Adipose Stromal Vascular Fraction Cell Therapy for Multiple Sclerosis. Journal of Translational Medicine, 2009 Source: ScienceDaily � 1995-2009 ScienceDaily LLC (24/04/09)

Effect of craniosacral therapy on lower urinary tract signs and symptoms in multiple sclerosis

Thu, 23 Apr 2009 07:19:00 EST

To examine whether craniosacral therapy improves lower urinary tract symptoms of multiple sclerosis (MS) patients. A prospective cohort study. Out-patient clinic of multiple sclerosis center in a referral medical center. Hands on craniosacral therapy (CST). Change in lower urinary tract symptoms, post voiding residual volume and quality of life. Patients from our multiple sclerosis clinic were assessed before and after craniosacral therapy. Evaluation included neurological examination, disability status determination, ultrasonographic post voiding residual volume estimation and questionnaires regarding lower urinary tract symptoms and quality of life. Twenty eight patients met eligibility criteria and were included in this study. Comparison of post voiding residual volume, lower urinary tract symptoms and quality of life before and after craniosacral therapy revealed a significant improvement (0.001>p>0.0001). CST was found to be an effective means for treating lower urinary tract symptoms and improving quality of life in MS patients. Raviv G, Shefi S, Nizani D, Achiron A. Urology Department, Sheba Medical Center, Tel Hashomer, Israel Source: Pubmed PMID: 19341983 (23/04/09)

Pivotal MBP8298 multiple sclerosis trial receives final positive review from Data Safety Monitoring Board

Wed, 22 Apr 2009 03:41:00 EST

BioMS Medical Corp. announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase III MAESTRO-01 Canadian/European trial of dirucotide in patients with secondary progressive MS has completed a safety analysis and recommended that the trial continue as per the protocol. This was the final scheduled review by the DSMB prior to the completion of MAESTRO-01. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. Results from MAESTRO-01 are expected in the second half of this year. About MAESTRO-01 MAESTRO-01 is a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide in patients with secondary progressive MS. The study is being conducted at 47 sites across Canada and nine countries in Europe and includes 611 patients being administered either dirucotide or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease, as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 70% of all MS patients are HLA-DR2 and/or HLA-DR4 positive). Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. Source: BioMS Medical Corp. (22/04/09)

Birmingham heads major study into multiple sclerosis in children

Tue, 21 Apr 2009 11:11:00 EST

The first major scientific study into multiple sclerosis in children in the UK has begun at Birmingham Children's Hospital to attempt to understand the debilitating condition. Researching doctors have been awarded a �400,000 grant by Action Medical Research and the MS Society, one of the largest it has ever given out. The study will follow a group of children for five years to give more insight into how MS progresses from an early age, and increase understanding of the condition among doctors caring for children and young people. Dr Doug Brown, biomedical research manager for the MS Society, said: "If we can pin down what happens very early on in MS, this will give us vital clues as to how the condition develops in adulthood. "MS isn't considered to be a childhood condition but we need to beat this misconception because it makes life tougher for those young people who live with it day in, day out." Current research into the number of children affected by MS is poor, but suggests that the onset of the condition occurs before the age of 16 in 0.4 to 10.5 per cent of cases, which could be anything up to 9,000 people in the UK. Dr Evangeline Wassmer is leading the study in Birmingham with other centres in Oxford, Bristol, Nottingham and London taking part. Source: Birmingham Mail.net � 2009 Trinity Mirror Midlands Limited

Genetic hope for Multiple Sclerosis and cancer patients

Mon, 20 Apr 2009 02:34:00 EST

Scots scientists have discovered genetic "brakes" which could slow down or stop diseases such as multiple sclerosis and cancer, it was announced yesterday. In what has been hailed as a "big step" towards answering one of medical science's great questions, the findings of researchers at the Roslin Institute could lead to new treatments and even cures for illnesses which affect the immune system. It was previously thought that a select group of "master" genes was responsible for controlling the growth of cells that can cause the conditions. But the study discovered that there are actually hundreds of genes which interact with each other in a way that is much more complicated than previously thought. MS, a disease in which the immune system mistakenly attacks and damages the myelin sheath that protect nerve cells, can cause symptoms ranging from vague tingling to blindness and paralysis. It affects one in every 500 people in Scotland - the highest proportion in the world - and nearly 100,000 across the UK. Professor David Hume, the director of the University of Edinburgh's Roslin Institute, said a whole new field of scientific research had been opened up, which would dramatically alter the way in which vaccines were used and drugs were tested. MS charities last night welcomed the findings which, they said, highlighted Scotland's leading role in research into the illness, while cancer specialists described the breakthrough as "exciting". Professor Hume said: "This research provides an incredible resource for the study of immunity and disease in humans and animals. This study has effectively shown us where the brakes are which could slow down or stop diseases like cancer and multiple sclerosis. We believe that this could lead to treatments and cures for many diseases of the immune system." The scientists said they believed that variations in this network explained why people could develop diseases in different ways. The team hopes that, by identifying weak spots in the gene structure, they will be able to stop the growth of tumours, enabling the growth of healthy cells................ For the full report please go to MSRC: MS Research News : MS and Genetics Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1347

Neurologists will use oral Multiple Sclerosis drugs as first line treatment less than 30% of the time

Thu, 16 Apr 2009 03:51:00 EST

Decision Resources finds that surveyed neurologists anticipate that less than 30 percent of their use of emerging oral agents --- Merck Serono's oral cladribine, Novartis/Mitsubishi Pharma's fingolimod (FTY-720) --- for the treatment of multiple sclerosis will be in the first line. Surveyed neurologists expect to use these drugs in patients who refuse injectables, filling an important unmet need and potentially increasing the drug-treatment rate in newly diagnosed patients. "Surveyed neurologists' responses suggest that Biogen Idec's Avonex is more at-risk than Teva's Copaxone of losing share upon the launch of either oral cladribine or fingolimod, as more physicians cite Avonex as having potential for being replaced by either emerging oral agent," stated Amanda Puffer, M.Sc., analyst at Decision Resources. "However, approximately half of the surveyed neurologists who are aware of these therapies are unsure if they will prescribe them, most likely because of uncertainty about these agents' side-effect/safety profiles." The new report entitled Treatment Algorithms in Multiple Sclerosis also finds that only 38.8 percent of newly diagnosed patients receive a drug within one year of their first diagnosis. This highlights the substantial room for increased uptake of disease-modifying therapies in newly diagnosed patients. While surveyed neurologists indicate they prescribe disease-modifying therapies to the majority of relapsing-remitting patients (the dominant multiple sclerosis subtype), they are less likely to prescribe disease-modifying therapies to patients with clinically isolated syndrome (early-stage multiple sclerosis). This is despite clinical studies indicating that early initiation of disease-modifying therapies can delay progression of the disease, and specifically, delay disability progression. "Those patients who do not start disease-modifying treatment right away represent an untapped opportunity for marketers of disease-modifying drugs," added Ms. Puffer. "Treatment rates could be improved, especially for patients with early stage disease, through increased awareness among both neurologists and primary care physicians, of the benefits surrounding early treatment initiation. These improvements would facilitate increased use of disease-modifying therapies." Soure: Decision Resources �2009 PR Newswire.(16/04/09)

Dirucotide for Multiple Sclerosis trial given continuation by independent safety drug board

Tue, 14 Apr 2009 11:31:00 EST

BioMS shares jumped more than 12 percent on Tuesday after an independent safety drug board recommended the biotech company continue trials of its multiple sclerosis treatment. The company said the U.S. Data Safety Monitoring Board completed a safety analysis of its phase 3 Maestro-03 trial of dirucotide, used for the treatment of secondary progressive MS, (SPMS) and ruled that the company should continue. SPMS is characterised by a steady progression of clinical neurological damage, with or without superimposed relapses and minor remissions. Dirucotide is being studied in two late-stage trials -- in the United States and across Europe and Canada -- as a treatment for SPMS. Key results are due later this year. "We believe the Data Safety Monitoring Board's decision today to continue the trial bodes well for the safety of the drug, but in our view does not impact the potential efficacy results coming out, which we continue to believe to be risky, but if it works could be a major positive catalyst for the stock," said Maher Yaghi, an analyst at Desjardins Securities in Montreal................ For the full report please go to MSRC: MS Research News : Drugs : MBP8298

Genetically modified stem cells treat MS like disease in mice

Fri, 10 Apr 2009 04:00:00 EST

Mice with a human equivalent of multiple sclerosis have been successfully treated using genetically modified stem cells, say a group of Australian researchers. The work, led by Dr James Chan of Monash University's Centre of Inflammatory Diseases, may lead to the development of a similar technique to treat autoimmune diseases in humans. Autoimmune diseases, such as type 1 diabetes and multiple sclerosis, are caused when immune cells, called T cells, incorrectly identify proteins created by the body as foreign objects, such as bacteria, and attack them. To prevent theese rogue T cells from entering the bloodstream, the immune system lures them with 'self-proteins' while they are developing in the thymus. T cells that bind tightly to these self-proteins are destroyed by the body's immune system. Some slip through this 'net' and for some people result in auto-immune disease. Fully recovered Chan and colleagues genetically modified a specific type of stem cell, which produce more self-protein to ensure that dangerous T cells are more effectively removed from the system. In the study, which appeared in the Journal of Immunology, mice were inoculated to develop experimental autoimmune encephalomyelitis (EAE), the human equivalent of multiple sclerosis. The genetically modified stem cells were then transplanted into the mice. "After the transplantation, the mice are completely resistant to disease," says Chan. While initial results are promising, Chan says human clinical trials would not be possible for some time. "Before we transplant the stem cells we wipe out the immune system of the mice using high doses irradiation," says Chan. He says this level of irradiation would not suitable for humans. The team is now looking at ways of overcoming the need for radiation, in order to make the procedure clinically viable..................... For the full report please go to MSRC: MS Research News : Stem Cell Research & Treatment : Multiple Sclerosis Specific Stem Cell Research

Vitamin D may exacerbate autoimmune disease

Fri, 10 Apr 2009 02:54:00 EST

Deficiency in vitamin D has been widely regarded as contributing to autoimmune disease, but a review appearing in Autoimmunity Reviews explains that low levels of vitamin D in patients with autoimmune disease may be a result rather than a cause of disease and that supplementing with vitamin D may actually exacerbate autoimmune disease. Authored by a team of researchers at the California-based non-profit Autoimmunity Research Foundation, the paper goes on to point out that molecular biologists have long known that the form of vitamin D derived from food and supplements, 25-hydroxyvitamin D (25-D), is a secosteroid rather than a vitamin. Like corticosteroid medications, vitamin D may provide short-term relief by lowering inflammation but may exacerbate disease symptoms over the long-term. The insights are based on molecular research showing that 25-D inactivates rather than activates its native receptor - the Vitamin D nuclear receptor or VDR. Once associated solely with calcium metabolism, the VDR is now known to transcribe at least 913 genes and largely control the innate immune response by expressing the bulk of the body's antimicrobial peptides, natural antimicrobials that target bacteria. Written under the guidance of professor Trevor Marshall of Murdoch University, Western Australia, the paper contends that 25-D's actions must be considered in light of recent research on the Human Microbiome. Such research shows that bacteria are far more pervasive than previously thought - 90% of cells in the body are estimated to be non-human - increasing the likelihood that autoimmune diseases are caused by persistent pathogens, many of which have yet to be named or have their DNA characterized. Marshall and team explain that by deactivating the VDR and subsequently the immune response, 25-D lowers the inflammation caused by many of these bacteria but allows them to spread more easily in the long-run. They outline how long-term harm caused by high levels of 25-D has been missed because the bacteria implicated in autoimmune disease grow very slowly. For example, a higher incidence in brain lesions, allergies, and atopy in response to vitamin D supplementation have been noted only after decades of supplementation with the secosteroid..................... For the full report please go to MSRC: MS Research News : Vitamin D Research

Positive efficacy results reported for pre-clinical trial of BVA-101 for Multiple Sclerosis

Thu, 02 Apr 2009 11:02:00 EST

Biovista Inc. today announced that BVA-101, its drug targeting Multiple Sclerosis (MS), has shown significant positive results in the MOG-induced Experimental Allergic Encephalomyelitis (EAE) murine model of MS. BVA-101, an existing drug that Biovista repositioned in MS and is aimed at neuroprotection, was shown to have both efficacy in reducing symptoms and no toxic effects in this well established model of MS. "We are excited about these early results that confirm the predictive capability of our repositioning platform technology and encourage us to further develop this compound in a disease area where there is a significant need for new therapies" said Aris Persidis, Ph.D., President of Biovista. "What is also encouraging is that we reached this stage just 4 months after deciding to work in MS. At the present time we are exploring all options available to us, including the further co-development with a pharmaceutical company and the licensing of the IP to a generics company" Dr. Persidis added.............. For the full report please go to MSRC: MS Research News : Drugs : Further Possible MS Drugs and Treatments

Depressive symptoms and coping in newly diagnosed patients with multiple sclerosis

Thu, 02 Apr 2009 04:35:00 EST

Background: Multiple sclerosis (MS) is a chronic disease with unclear etiology, unpredictable clinical course, and no cure. Patients' ability to cope with MS moderates the adaptation to the disease. Objectives: To compare coping in patients recently diagnosed with MS and healthy controls and to study the association between depressive symptoms and patients' coping styles. Methods: A sample of 86 recently diagnosed patients with definite or probable MS and 93 healthy population controls completed questionnaires assessing coping styles and depressive symptoms. Results: Compared with healthy controls, patients with MS used significantly less the problem focused strategies including planning, restraint coping, and seeking social support for instrumental reasons, and they used less the emotion-focused strategies seeking social support for emotional reasons, focusing on and venting of emotions, and positive reinterpretation and growth. The mean Beck Depressive symptoms Inventory scores were 10.8 and 4.7 in patients and controls, respectively. In stress situations connected to MS, depressive symptoms in these patients were related to the problem-focused strategies of restraint coping and planning, the emotion-focused strategy of focusing on and venting of emotions, and the avoidance strategies of behavioural- and mental disengagements, and denial. Lode K, Bru E, Klevan G, Myhr K, Nyland H, Larsen J. The Norwegian Centre for Movement Disorders, Stavanger University Hospital, Stavanger, Norway. Source: Pubmed PMID: 19299438 (02/04/09)

Cats' central nervous system can repair itself and restore function

Wed, 01 Apr 2009 06:34:00 EST

Scientists studying a mysterious neurological affliction in cats have discovered a surprising ability of the central nervous system to repair itself and restore function. In a study published March 30, 2009 in the Proceedings of the National Academy of Sciences, a team of researchers from the University of Wisconsin-Madison reports that the restoration in cats of myelin - a fatty insulator of nerve fibers that degrades in a host of human central nervous system disorders, the most common of which is multiple sclerosis - can lead to functional recovery. "The fundamental point of the study is that it proves unequivocally that extensive remyelination can lead to recovery from a severe neurological disorder," says Ian Duncan, the UW-Madison neuroscientist who led the research. "It indicates the profound ability of the central nervous system to repair itself." The finding is important because it underscores the validity of strategies to reestablish myelin as a therapy for treating a range of severe neurological diseases associated with the loss or damage of myelin, but where the nerves themselves remain intact. Myelin is a fatty substance that forms a sheath for nerve fibers, known as axons, and facilitates the conduction of nerve signals. Its loss through disease causes impairment of sensation, movement, cognition and other functions, depending on which nerves are affected. The new study arose from a mysterious affliction of pregnant cats. A company testing the effects on growth and development in cats using diets that had been irradiated reported that some cats developed severe neurological dysfunction, including movement disorders, vision loss and paralysis. Taken off the diet, the cats recovered slowly, but eventually all lost functions were restored.......................... For the full report please go to MSRC: MS Research News : Myelin Research -http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1845

Genzyme acquires worldwide rights to multiple sclerosis drug Campath

Wed, 01 Apr 2009 03:09:00 EST

Genzyme Corp. has announced an agreement with Bayer HealthCare to acquire the worldwide rights of Campath, or alemtuzumab. The deal will give Genzyme primary responsibility for the development and commercialisation of Campath for the treatment of multiple sclerosis, or MS. Bayer will continue to fund a portion of the drug's development in MS and will retain an option to co-promote the product in MS upon approval. The deal is structured as an earn-out arrangement. Bayer will receive payments based on revenues and potential milestone payments if cumulative revenue targets are achieved. There are no upfront payments for the rights of these three drugs. In addition, Genzyme will assume sole responsibility for the worldwide sales and marketing of Campath in B-cell chronic lymphocytic leukemia, or CLL. Meanwhile, Bayer will retain the right to develop and commercialise alemtuzumab in solid organ transplant indications. Genzyme said the transaction is accretive and has already reflected in the company's 2009 revenue and non-GAAP earnings per share guidance. The deal also supports the company's goal of 20% compound average non-GAAP earnings growth from 2006 to 2011. Source: RTT News � 2009 RTTNews(01/04/09)

Acorda says FDA seeks additional data on NDA for multiple sclerosis drug

Tue, 31 Mar 2009 15:59:00 EST

Biotechnology company Acorda Therapeutics, Inc. revealed that it received a "refuse to file letter" from the U.S. Food and Drug Administration, or FDA, pertaining to its New Drug Application, or NDA, for Fampridine-SR, a new therapy under development for improving the walking ability in people suffering from multiple sclerosis. The Hawthorne, New York-based company said that the FDA has raised "format issues" concerning its electronic submission, and has called for the reformatting of some of the data in the NDA. The agency has also asked for some additional supporting information. The company, however, noted that the FDA has not requested or recommended additional clinical or other studies. The company said it will seek a meeting with the FDA at the earliest to discuss its comments on the NDA filing. As per the FDA web site, incomplete NDAs become the subject of a formal refuse-to-file action, with the applicant receiving a letter detailing the decision and the deficiencies that form its basis. This decision must be forwarded within 60 calendar days after the NDA is initially received by CDER. Source: RTT News � 2009 RTTNews (31/03/09)

Massachusetts scientists make stem cell discovery

Tue, 31 Mar 2009 03:57:00 EST

Cell Multiplication Controlled by a Surprising set of Genes. Stem cell researcher Dr. Ann Kiessling announced the discovery of cell characteristics that may explain important differences between embryonic stem cells and adult stem cells. Scientists have for years been frustrated in their efforts to grow the trillions of adult stem cells needed for therapies, which is why embryonic stem cells seem promising -- they can multiply endlessly and also develop into any cell in the body. Kiessling discovered that early human embryo cells express CLOCK, and other circadian genes, that other human cells growing in laboratories did not. This was a surprise. Although scientists have recently become aware that human tissues have a circadian oscillator that cycles every 24 hours, in phase with the master circadian pacemaker in the brain that responds to light and dark, early embryos seemed too small to function like a tissue. Kiessling also discovered that the RB gene, a powerful cell blockade, was turned off in the early embryo cells. This was also a surprise because RB is a well-studied blockade that prevents cells from multiplying unless needed and stimulated by growth factors. The lack of RB in the early embryo cells, in combination with the circadian oscillator, are unique characteristics that together enable independent, continuous cell duplication................. For the full report please go to MSRC: MS Research News : Stem Cell Research & Treatment : General Stem Cell Research

Multiple sclerosis associated with lower cancer risk

Tue, 31 Mar 2009 02:50:00 EST

A new study shows that people with multiple sclerosis may be at a lower risk for cancer overall, but at a higher risk of developing certain types of cancer, such as brain tumors and bladder cancer. The study is published in the March 31, 2009, print issue of Neurology, the medical journal of the American Academy of Neurology. Researchers looked at the medical records of 20,000 people with multiple sclerosis and 204,000 people without the diagnosis. After 35 years, they found that the people with MS had a decreased overall risk of cancer by 10 percent compared to people who did not have the disease. The result was more pronounced in women. However, for people with MS the risk for certain cancers, such as brain tumors and bladder and other urinary organ cancers, increased by up to 44 percent compared to people without MS. Scientists also evaluated the parents of people with MS to determine whether there was a possible genetic link. They found that there was no overall increased or decreased risk of cancer among either mothers or fathers of those with MS, compared to parents of people without MS................ For the full report please go to MSRC: MS Research News : General Health : Cancer

Bayer offers new Betaferon(R) titration pack

Sun, 29 Mar 2009 09:14:00 EST

Bayer will launch a titration pack for patients with multiple sclerosis (MS) that is specially designed to make it easier for them to start Betaferon� (interferon beta-1b) therapy. From now on, the titration pack will be available in Germany. More European countries will follow in 2009. The four-week pack facilitates a gradual increase in dose as recommended for patients new on Betaferon�. Betaferon� is a well-established therapy for people starting their MS treatment as early as after the first signs of the condition. Findings from the recent landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) trial have shown that gradual dose titration of the medication contributes to a high acceptance of Betaferon� treatment from the start. Delivering Betaferon� in an easy-to-use titration pack for the first four weeks of therapy will simplify the titration process for physicians, MS-nurses and patients. "The new pack will make it easier for people with MS to start therapy. The titration process helps the body to better adjust to the medication, resulting regularly in fewer side effects. This is important because greater patient comfort, especially during the start of the therapy, can improve patient compliance to therapy and, consequently, its effectiveness," said Habib Dable, Vice President and Global Head, Neurology/Ophthalmology of Bayer Schering Pharma`s Global Business Unit Specialty Medicine. Source: Medical News Today � 2009 MediLexicon International Ltd (29/03/09)

Stopping autoimmunity before it strikes

Thu, 26 Mar 2009 05:31:00 EST

Current research describes a new method to track the development of autoimmune diseases before the onset of symptoms. The related report by Zangani et al, "Tracking early autoimmune disease by bioluminescent imaging of NF-κB activation reveals pathology in multiple organ systems," appears in the April 2009 issue of The American Journal of Pathology. Autoimmune diseases such as lupus, multiple sclerosis, rheumatoid arthritis and diabetes are caused when the immune system attacks the body's own cells. Normally, immune cells are prevented from attacking normal cells; however, in patients with autoimmune disease, this "tolerance" is lost. The immediate causes of autoimmune diseases remain unknown, partially due to the inability to detect disease before the onset of symptoms. Early detection of autoimmune disease is critical for assessing new treatments. The molecule NF-κB is activated by inflammation, which plays a key role in autoimmune disease development, making NF-κB a prime candidate to track autoimmune activity. Researchers at the University of Oslo led by Drs. Ludvig Munthe and Bjarne Bogen in collaboration with Rune Blomhoff engineered NF-κB such that it would emit light when activated. Using a mouse model of systemic autoimmunity with features of lupus, they found that NF-κB activation signals were present in affected organs several weeks before the clinical manifestations of disease. The light signal intensity correlated with disease progression. NF-κB tracking may therefore provide a new tool in the evaluation of early autoimmune therapies........................... For the full report please go to MSRC: MS Research News : New Discoveries : Antibodies, B Cells,T-Cell Activation and Immune Response

Possible PML-related antibody test for JC virus muted by Biogen

Thu, 26 Mar 2009 03:11:00 EST

Biogen Idec Inc said on Wednesday it is developing a test that can identify the presence of a virus that can cause a potentially deadly brain infection in certain patients taking its multiple sclerosis drug Tysabri, and hopes to have it available by year-end. Cecil Pickett, Biogen's head of research and development, said the company is working on an antibody-based test that can ascertain the presence in a patient's blood of the JC virus, which can cause progressive multifocal leukoencephalopathy, or PML. Tysabri, which Biogen co-markets with Ireland's Elan Corp, is the biotech company's most important product with 2008 sales of $813 million. But sales have been hurt by the drug's association with PML. It was withdrawn from the market in 2005 but reintroduced in July 2006 with stricter safety warnings as patients with the degenerative disease were willing to assume the risk given the drug's clear benefits over other treatments. Tysabri not only delays progression of MS but in some cases has shown improvement of disability. Last month, Biogen scaled back growth projections for the drug, conceding it will not meet its previous forecast of 100,000 patients on Tysabri by the end of 2010.................. For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing News : TYSABRI�

Genomics of ethnicity may lead to possible treatment differences in Multiple Sclerosis in caucasians and negros

Wed, 25 Mar 2009 07:22:00 EST

Researchers have assembled the first-ever map of copy number variants (CNV)-- duplications, deletions or rearrangements in the genome that result in different gene copy numbers -- in African Americans. The study, appearing in BMC Genetics, also identified two CNVs that differed in frequency between African American genomes and those in people of European descent. Joseph McElroy, a postdoc in the lab of neurologist Jorge Oksenberg at the University of California, San Francisco, and lead author, said that the study will provide a baseline informing his lab's future investigations into the genetic underpinnings of multiple sclerosis in African Americans. "The reason we wanted to [compare CNVs in African Americans and whites] is because most of the literature on this has been done in whites," he said. "On a genome-wide level, African Americans haven't been studied for diseases that are present in African American populations." McElroy and his colleagues screened the genomes of 385 healthy African Americans, and 435 healthy white people primarily from Europe or North America. The researchers found a total of 1972 CNVs in white subjects and 1362 CNVs in African Americans - overall, a statistically insignificant difference. They did pull out two significant differences: a duplication on chromosome 17 that was nearly six times more frequent in whites and another on chromosome 15 that was almost twice as common in whites than in African Americans. "What they found was not surprising in the sense that African Americans are as variable as Caucasians," said Bob Ferrell, a human geneticist at the University of Pittsburgh who was not involved with the study. "It'll only become important if it turns out that one or more of these regions where blacks and whites differ is related to susceptibility to some disease or genotype........................." For the full report please go to MSRC: MS Research News : MS and Genetics Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1347

Possible treatment for PML in Tysabri Multiple Sclerosis patients under investigation

Wed, 25 Mar 2009 06:45:00 EST

Helen Yates, Chief Executive of the Multiple Sclerosis Resource Centre (MSRC) commenting on this news, said: "We truly hope that the research leads to a treatment for this very worrying and potentially life threatening condition. It is important that people affected by MS that are undergoing treatment with Tysabri have as much reassurance as possible about the potential side effects and the ability to treat them should they arise." A possible treatment for a potentially fatal side effect of multiple sclerosis therapy, Tysabri, and other immuno-modulating drugs is currently under investigation. Biogen Idec, Elan's partner in the development and sale of Tysabri, is testing the efficacy of a malaria pill developed during the Vietnam war in treating progressive multifocal leukoencephalopathy (PML), the brain infection that has been tied to use of Tysabri, according to Al Sandrock, Biogen's head of neurology research. Tysabri was pulled from the market in 2005 after three PML cases were reported. It was reintroduced a year later when US regulators said the medication's effectiveness, twice that of other MS drugs, outweighed its risks. However, the threat of PML has affected sales of the treatment which, although a successful drug in commercial terms, is well short of the figures initially expected. The companies have reported five new PML cases since July 2008, reigniting concerns of patients who believe a safer Tysabri would be their best treatment option, said John Richert of the US National Multiple Sclerosis Society................. For the full report please go to MSRC: MS Research News : Drugs : Disease Modifying Drugs : Disease Modifying Drugs Ongoing Research : TYSABRI� Ongoing Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1768

Valomaciclovir (EPB-348) to be assessed as an adjunctive therapy in Multiple Sclerosis

Tue, 24 Mar 2009 10:15:00 EST

Epiphany Biosciences announced today that the company plans on filing an IND with the Food and Drug Administration (FDA) to study the potential impact of using the antiviral medication valomaciclovir (EPB-348) as an adjunctive therapy in the treatment of multiple sclerosis. Valomaciclovir has been shown to possess potent antiviral activity in vitro against a number of herpes-related viruses, including herpes simplex (HSV), Epstein-Barr virus (EBV), herpes zoster (HZV), and human herpes virus 6 (HHV-6). The drug is currently being tested in a phase 2b study in patients with acute herpes zoster infection (shingles) and in a phase 2a study in patients with acute infectious mononucleosis. "There has been accumulating evidence that MS may be the result of multiple contributing factors, including infection by the Epstein-Barr virus," stated Fred Volinsky, MD, CEO of Epiphany. "Based on these data, we feel this is the right time to explore the potential use of valomaciclovir to help manage this illness that can affect young adults as well as children...................." For the full report please go to MSRC: MS Research News : Drugs : Further Possible MS Drugs and Treatments - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1397

Next generation of Multiple Sclerosis drugs may be based on whole new delivery design

Fri, 20 Mar 2009 02:49:00 EST

If you're of a certain age, you'll remember Buckminster Fuller's distinctive "geodesic domes" - soccer-ball-shaped structures that the late futurist envisioned as ideal human domiciles. Tel Aviv University chemists remember them too - and are now putting them to use in the treatment of multiple sclerosis (MS). In partnership with a group of Prof. Howard Weiner from Brigham and Women's Hospital at Harvard Medical School, Dr. Michael Gozin from TAU's School of Chemistry is attempting to create the next generation MS drug based on a delivery platform of "buckyballs," small soccer-ball-shaped molecules sometimes called fullerenes. Made from pure carbon, the buckyballs can function as invigorating antioxidants to keep neurons in the brain alive and kicking. There is currently no cure for MS. Buckyballs and related carbon nanotubes have enormous potential to be used in sensors and electronic applications allowing scientists to manufacture much more smaller and faster processors. These carbon-based materials have a huge range of possibilities in nanotechnology applications as well. Until now, buckyball-derived therapeutics have not been used in medicine. But the TAU and Harvard teams believe that they may resolve issues related to this nanomaterial development, and are seeking to commercialise their patented invention. If successful, the TAU-Harvard collaboration could provide new hope to millions of MS sufferers, and would make Bucky himself proud...................... For the full report please go to MSRC: MS Research News : New Discoveries : Technology

Apitope announces licensing agreement for ATX-MS-1467 for Multiple Sclerosis

Tue, 17 Mar 2009 07:58:00 EST

Apitope, a Bristol University spinout company that is looking at a potential therapy for people with Multiple Sclerosis (MS), has announced a licensing agreement for up to �154 million in upfront, development and commercialisation milestone payments, in addition to royalties, to develop its peptide therapeutic for the treatment of MS. Apitope founded by Professor David Wraith in the University's Department of Cellular and Molecular Medicine, has granted exclusive worldwide rights to Merck Serono to develop and commercialise Apitope's peptide therapeutic product, ATX-MS-1467. Apitope is eligible to receive up to �154 million in upfront, development and commercialisation milestone payments, in addition to royalties on the net sales of products resulting from the collaboration. Dr Neil Bradshaw, Director of Enterprise at the University, said: "The agreement marks a significant step forward for Apitope and is a milestone for enterprise at the University, especially in terms of our involvement in helping to accelerate the technology's development from the laboratory into the market place. "It is also further evidence of the significant economic impact of research conducted here at Bristol." ATX-MS-1467 is a novel peptide-based therapeutic derived from Apitope's proprietary technology platform. Under the terms of the agreement, Apitope will receive an upfront payment and will initially be responsible for the further development of ATX-MS-1467, for which Merck Serono will fund the costs. Merck Serono will be responsible for all development activities from the beginning of Phase II clinical trials. The company will also provide committed funding to Apitope for research on other novel therapeutic peptides for the treatment of MS...................... For the full report please go to MSRC: MS Research News : Drugs : ATX-MS-1467

Dendritic cells ensure immune tolerance

Tue, 17 Mar 2009 05:06:00 EST

One of the most important tasks of the immune system is to identify what is foreign and what is self. If this distinction fails, then the body's own structures will be attacked, the result of which could be an autoimmune disease such as diabetes mellitus type 1 or multiple sclerosis. The only way to protect against these afflictions is to destroy all immune factors that turn against the body's own tissue - in other words: immune tolerance. A team working with LMU researcher Dr. David V�hringer has now investigated exactly what role dendritic cells play in this process. There has long been suspicion that these cells, which are important for the body's defenses, are also essential for the establishment and maintenance of immune tolerance. "We investigated mice that lacked this cell type from birth," reports V�hringer. "It turned out that immune cells that attack the body's own tissue survive in these animals, and thereby trigger an autoimmune response. It follows that dendritic cells play a major part in protecting against autoimmune disease." T cells are a type of white blood cell that are key actors in the body's immune defenses. Each T cell has a receptor on its surface for recognizing just one single antigen. Antigens are molecular structures, mostly fragments of proteins. T cells do not dock onto free antigens, however: they rely on other cells which can present antigens to them. It is the dendritic cells that are primarily responsible for this job. They present the T cells with various antigens, and if an antigen matches a receptor, then that T cell will trigger an immune response from the body.................... For the full report please go to MSRC: MS Research News : New Discoveries : Dendritic Cells

Blocking Protein May Help Ease Painful Nerve Condition

Mon, 16 Mar 2009 11:05:00 EST

Scientists have identified the first gene that pulls the plug on ailing nerve cell branches from within the nerve cell, possibly helping to trigger the painful condition known as neuropathy or neuropathic pain. The condition is a side effect of some forms of chemotherapy and can also afflict patients with cancer, diabetes, kidney failure, viral infections, neurodegenerative disorders, such as Multiple Sclerosis and other ailments. Researchers at Washington University School of Medicine in St. Louis showed that blocking the dual leucine zipper kinase (DLK) gene inhibits degeneration of ailing nerve cell branches, possibly preventing neuropathy. "Neuropathy can become so extraordinarily painful that some patients stop taking their chemotherapy, regardless of the consequences in their fight against cancer," says co-senior author Aaron DiAntonio, M.D., Ph.D., associate professor of developmental biology. "So we're very excited about the possibilities this gene may offer for reducing that pain." The findings were published online on March 15 in Nature Neuroscience............................ For the full report please go to MSRC: MS Research News : Pain Research

Researchers explore the benefits of supersized doses of Vitamin D for Multiple Sclerosis and other diseases

Mon, 16 Mar 2009 04:37:00 EST

Researchers are taking a fresh look at vitamin D - the over-the-counter supplement much-ballyhooed as a way to prevent diseases - to determine whether it could be effective as a medical treatment for those who already have chronic illnesses such as cancer. Although the investigations are in their early stages, any successful outcomes could be a major health breakthrough, giving patients an inexpensive treatment option that's as close as the nearest pharmacy. Already the so-called sunshine vitamin is glowing brightly in medical circles, with recent studies showing its efficacy in preventing everything from cancer to the flu. Typical of the recent investigations was one conducted at St. Michael's Hospital in Toronto, where multiple sclerosis patients received one of the largest vitamin D doses ever dispensed in a clinical setting. It yielded some tantalizing evidence that supersizing the nutrient helps calm symptoms of the neurological disease. The MS patients took up to 40,000 IU daily, or the amount in 50 multivitamins or 400 cups of fortified milk.................................................... For the full report please go to MSRC: MS Research News : Vitamin D Research - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1334

Plans to market Sativex in the UK for Multiple Sclerosis spasticity announced

Mon, 16 Mar 2009 03:18:00 EST

GW Pharmaceuticals has announced plans to submit an application to market its cannabis-based multiple sclerosis (MS) treatment, Sativex, in the UK. This follows the announcement on Thursday of positive preliminary results for a Phase III study, which showed that in nearly three-quarters of people with MS taking a fixed dose of Sativex, there was an improvement of more than 30% in levels of spasticity. The Phase III study used an enriched design whereby 573 patients initially received Sativex for 4 weeks in a single blind manner (Phase A), following which Sativex responders (n=241) were randomized to continue on Sativex or switch to placebo for a further 12 weeks in a double-blinded manner (Phase B). During the randomized period, patients were not permitted to adjust their dose. Source: GW Pharmaceuticals (16/03/09)

GW reports highly statistically significant results in Sativex� pivotal phase III study in MS spasticity

Thu, 12 Mar 2009 09:25:00 EST

GW Pharmaceuticals plc today announces positive preliminary results from a pivotal Phase III double-blind randomised placebo-controlled study of Sativex� in patients with spasticity due to Multiple Sclerosis (MS), who have achieved inadequate spasticity relief with existing therapies. This study was requested by the UK regulator in order to gain approval in this indication and following today's results, GW will file a regulatory submission in Q2 09. This Phase III study used an enriched design whereby 573 patients initially received Sativex for 4 weeks in a single blind manner (Phase A), following which Sativex responders (n=241) were randomized to continue on Sativex or switch to placebo for a further 12 weeks in a double-blinded manner (Phase B). During the randomized period, patients were not permitted to adjust their dose. This study is the largest study GW has undertaken and recruitment was achieved in just ten months using 52 hospital sites in five countries - UK, Spain, Italy, Czech Republic and Poland. The prospectively defined primary efficacy endpoint of the study - the difference between the mean change in spasticity severity of Sativex vs Placebo in Phase B - was highly statistically significantly in favour of Sativex (p=0.0002). The numeric difference between the two groups as measured on a Numeric Rating Scale was 0.84 units from a baseline of 3.89, greater than that achieved in previous studies. The difference between Sativex and placebo was also significant for a number of secondary endpoints. 74% of Sativex patients achieved an improvement of greater than 30% in their spasticity score over the entire study versus 51% on placebo (p=0.0003). In addition, statistically significant improvements were also seen in spasm frequency (p=0.005), sleep disturbance (p<0.0001), patient global impression of change (p=0.023), and physician global impression of change (p=0.005). The study provides further evidence of Sativex's reassuring safety profile. The adverse event data in this study was superior to previous Sativex studies - an improvement which resulted from the modified dose titration regimen employed in the study....................... For the full report please go to MSRC: MS Research News : Drugs : Sativex - http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1814

Makers of potential Multiple Sclerosis vaccine, forced to quit UK

Wed, 11 Mar 2009 11:12:00 EST

Apitope Technology Ltd is a biopharmaceutical company that specialises in developing treatments for allergy and autoimmune diseases. Formed as a spin-out company in 2002, Apitope announced in 2007 it had developed a vaccine designed to halt multiple sclerosis in its tracks. Cherry Lewis talked to Professor David Wraith, founder and Chief Scientific Officer, about the vaccine and his struggle to get funding for clinical trials. David: About ten years ago, Geoff Watts from the BBC came to talk to me about autoimmunity for his Medicine Now programme that went out on Radio 4. One of the things we discussed was a new discovery we'd made that was a way of developing vaccines for treating autoimmune diseases and allergies, so-called therapeutic vaccines. They are based on the concept that has been well known for almost a century, namely allergic desensitisation, where people are given injections of the allergen that causes the reaction. Cherry: Is that the same principle as a vaccine for smallpox? David: Not really. With the smallpox vaccine, you're giving an attenuated form of the infectious agent which boosts the immune system without actually causing the disease. What we're talking about here are disorders of the immune system which respond to innocuous things such as house dust and pollen that cause an allergy, or proteins in your body that cause autoimmune diseases. In multiple sclerosis, for example, which is an autoimmune disease, the immune system attacks the myelin sheath around nerve cells - the insulating layer that allows the cells to conduct electrical signals. This causes the nerves to function poorly or die and the symptoms of MS to appear. In these 'hypersensitivity' diseases, the immune system is over-responding. We have developed vaccines that can control the immune response, based on the antigens to which the immune system is responding. Cherry: So how do you activate this desensitisation? David: There is a set of cells in the body called T-lymphocytes (T cells). Now we know that T cells respond to very small fragments (peptides) of whatever is causing the allergy or the autoimmune disease. We have developed a method of identifying and administering certain peptides so that instead of causing damage, they actually suppress the immune reaction. Cherry: How very exciting. What happened next? David: Well, I was talking to Geoff Watts about things and explaining how the biggest challenge we now faced was taking this to the next step, but that it was proving difficult to find funding. Although we have some very large and highly successful venture capital companies in the UK, none of them are funding medical development at an early stage. Cherry: What's the reason for that? Is it too high risk? David: And it's too long term. But what happened to us was very fortunate. An 'angel' investor heard about the programme and offered to help us. He gave us the money to develop our approach to the point where we could take it into clinical trials................... Helen Yates, Chief Executive of the Multiple Sclerosis Resource Centre (MSRC) said, "Whilst this work is very encouraging in terms of its potential to help people affected by MS, it is a damning indictment on the funding streams in the UK that it is such a struggle for people like Professor Wraith to gain funding to translate academic knowledge into advanced clinical trials. Nevertheless the vaccine looks to hold great hope for everyone in the MS community." For the complete interview please go to MSRC: MS Research News : Drugs : ATX-MS-1467

Study to evaluate the safety and tolerability of Natalizumab when added to Glatiramer Acetate for Multiple Sclerosis

Wed, 11 Mar 2009 04:40:00 EST

OBJECTIVE: To evaluate the safety and tolerability of natalizumab when added to glatiramer acetate (GA) in patients with relapsing multiple sclerosis. The primary outcome assessed whether this combination would increase the rate of development of new active lesions on cranial MRI scans vs GA alone. METHODS: This phase 2, randomized, double-blind, placebo-controlled study included patients aged 19 to 55 years who were treated with GA for at least 1 year before randomization and experienced at least one relapse during the previous year. Patients received IV natalizumab 300 mg (n = 55) or placebo (n = 55) once every 4 weeks plus GA 20 mg subcutaneously once daily for < or = 20 weeks. RESULTS: The mean rate of development of new active lesions was 0.03 with combination therapy vs 0.11 with GA alone (p = 0.031). Combination therapy resulted in lower mean numbers of new gadolinium-enhancing lesions (0.6 vs 2.3 for GA alone, p = 0.020) and new/newly enlarging T2-hyperintense lesions (0.5 vs 1.3, p = 0.029). The incidence of infection and infusion reactions was similar in both groups; no hypersensitivity reactions were observed. One serious adverse event occurred with combination therapy (elective hip surgery). With the exception of an increase in anti-natalizumab antibodies with combination therapy, laboratory data were consistent with previous clinical studies of natalizumab alone. CONCLUSION: The combination of natalizumab and glatiramer acetate seemed safe and well tolerated during 6 months of therapy. Goodman AD, Rossman H, Bar-Or A, Miller A, Miller DH, Schmierer K, Lublin F, Khan O, Bormann NM, Yang M, Panzara MA, Sandrock AW; GLANCE Investigators. - CDepartment of Neurology, University of Rochester Medical Center, Rochester, NY 14642, USA. Source: Neurology. 2009 Mar 3;72(9):806-12. (11/03/09)

Protein helps immune cells to divide and conquer

Tue, 10 Mar 2009 05:21:00 EST

Researchers at the University of California, San Diego School of Medicine have identified a key protein that is required for immune cells called B lymphocytes to divide and replicate themselves. The rapid generation of large numbers of these immune cells is critical to the body's antibody defense mechanism. However, when B cells grow unchecked, it can lead to immune cell cancers such as multiple myeloma or, when they grow to attack the wrong targets, such as in the autoimmune disease, Multiple Sclerosis. By discovering the role of the CD98hc protein, scientists may find new therapy targets for such diseases. The study from the laboratory of Mark H. Ginsberg, MD., professor of medicine, has been published online in advance of print in Nature Immunology. It describes why CD98hc is essential in order for B lymphocytes to transition into antibody-secreting cells. It also describes how this relates to the protein's role in the signaling ability of integrins - a large family of adhesion molecules that transfer information between the inside and outside of a cell. According to first author Joseph Cantor, PhD, UC San Diego School of Medicine, scientists have known for nearly 25 years that CD98hc, common to all vertebrates, probably played a role in their adaptive immune system, but it wasn't known how this protein functioned. "This protein was used as a marker of activation because it was found in low levels on resting lymphocytes," said Cantor. "But when B or T lymphocytes were stimulated by antigens - for instance, to protect the body against bacteria - levels of CD98hc went up 20 fold..............." For the complete report please go to MSRC: MS Research News : New Discoveries : Antibodies, B Cells,T-Cell Activation and Immune Response

Phase II follow-up data on BHT-3009 for Multiple Sclerosis

Mon, 09 Mar 2009 08:40:00 EST

An abstract titled "One Year Follow-up Results from a Phase II Trial of the BHT-3009 DNA Vaccine for Multiple Sclerosis," has been accepted for presentation at the 61st Annual American Academy of Neurology (AAN) meeting, to be held in Seattle, Washington from April 25 through May 2, 2009. Data in the abstract indicates that BHT-3009 has a durable effect and continues to have a favourable safety profile for up to 12 months following the completion of dosing. BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP) that aims to reprogram the immune system to tolerize to, rather than attack, myelin antigens in the central nervous systems of multiple sclerosis (MS) patients. In August 2008, Bayhill completed the 12-month follow-up phase (Survey Protocol) of a Phase II clinical trial of BHT-3009 in relapsing-remitting MS (RR-MS) patients. The Survey Protocol data demonstrated a decrease in relapse rates and a corresponding continued reduction in magnetic resonance imaging (MRI) gadolinium enhancing (Gd+) lesion activity. The Survey Protocol data builds on results previously published in Annals of Neurology (63(5):611-20, 2008), which demonstrated a reduction in MRI Gd+ lesions during the 44-week treatment period................. For the complete report please go to MSRC: MS Research News : Drugs : BHT-3009

Genetics studies provide new clues to why people develop MS

Fri, 06 Mar 2009 04:29:00 EST

New studies are deciphering the complex picture of genetic characteristics that make people susceptible to MS, thanks to international collaborations and unique population studies. Each gives important new clues about why people get MS. Additional large-scale studies, the first stages of which are already underway, promise to uncover the great majority of genes that convey risk for MS, which would pave the way for understanding the basic cause of MS and developing more rational therapies. CD58 Gene: When it completed the largest replicated whole genome scan (scan of all the genes in the body) for MS to date, the International MS Genetics Consortium (IMSGC) identified and validated variations in two genes that help regulate the immune system as clearly increasing genetic susceptibility to MS, and preliminarily identified several other genes of newly suspected importance in MS. Philip De Jager, MD, PhD (Brigham & Women's Hospital, Boston) and colleagues in the IMSGC now report on one of these other genes, CD58, which instructs the activation of T cells, major players in the immune attack on the brain and spinal cord in MS. They studied this gene in 1530 additional people with MS, and found further evidence of its association with the disease. They pinpointed a specific marker, or segment of DNA, on the gene that is associated with reduced susceptibility to MS. They also showed that the level of CD58 expression (that is, the amount of CD58 protein that is produced from the CD58 gene) is associated with remissions from MS disease activity. Manipulating CD58 is a strategy used in treat other autoimmune diseases, so this study may open up new therapeutic options for people with MS. (Proceedings of the National Academy of Sciences U S A 2009 Feb 23)........................ For the full report please go to MSRC: MS Research News : MS and Genetics Research

Report reveals the importance of studying Multiple Sclerosis in children

Fri, 06 Mar 2009 03:28:00 EST

An article published in the Spring 2009 edition of Multiple Sclerosis Quarterly Report, a joint publication of United Spinal Association and the North American Research Committee on Multiple Sclerosis (NARCOMS), reveals the importance of understanding the biological onset of Multiple Sclerosis in children as it can also lead to a greater understanding and treatment of MS in adults. The article by Jean Marie B. Ahorro, MD and Brenda L. Banwell, MD of The Hospital for Sick Children in Toronto, Ontario Canada, highlights some of the latest information on paediatric MS, including risk factors, diagnosis, symptoms, and treatment strategies. Presently, most care models for paediatric MS are based on protocols optimized in adults and pivotal studies of MS therapies are restricted to patients over 18 years of age. Conducting randomized control trials of paediatric MS has also been challenged by the rarity of the disease in children...................... For the full report please go to MSRC: MS Research News : Paediatric Multiple Sclerosis Research

Opexa provides key quality of life data on Tovaxin� for Multiple Sclerosis

Thu, 05 Mar 2009 09:46:00 EST

Opexa Therapeutics, Inc. announced an update on the continuing analysis of the company's Phase IIb TERMS clinical trial (Tovaxin� for Early Relapsing Multiple Sclerosis) for the treatment of MS. An analysis of the MS Quality of Life Inventory Data (MSQLI) from the 150 patient study has shown that in the complete modified intent to treat (mITT) population (n=142), patients treated with Tovaxin demonstrated a statistically significant improvement in the Impact of Visual Impairment Scale scores (p=0.028) compared to those on placebo. This improvement was observed within six months of completing the full course of treatment. Visual problems are a common, often disabling symptom in MS and according to the National Multiple Sclerosis Society can affect over 40% of patients. The Impact of Visual Impairment Scale consists of 5 items that assess the extent to which various activities dependent upon vision are affected by MS-related visual problems. In the other measures defined by the Health Status Questionnaire (SF-36) there was no significant change or worsening in any of the additional ten components comprising the evaluation. In a further analysis of the MSQLI data in patients with more active disease that comprise the prospective cohort at the center of the company?s evaluation (n=50), patients treated with Tovaxin demonstrated a statistically significant improvement in the Medical Outcomes Study Social Support Survey score compared to those on placebo (p=0.005). Similarly, there was no significant change or worsening in any of the other evaluable parameters within the prospective cohort...................................... For the full report please go to MSRC: MS Research News : Drugs : Tovaxin

Parasitic worms may lead to treatment for multiple sclerosis

Wed, 04 Mar 2009 09:07:00 EST

Scientists from The University of Nottingham will study the potential health benefits of parasitic worms as part of a study investigating treatments for people with the autoimmune condition multiple sclerosis (MS). It is thought that hookworms may play a role in damping down the immune system, which is overactive in people with MS, the most disabling neurological condition in young adults. The �400,000, three-year project funded by the MS Society, aims to determine whether infection with a small and harmless number of the worms can lead to an improvement on the severity of MS over a 12 month period. If the trial is successful, the worms have the potential to provide a simple, cheap, natural and controllable treatment for MS. The WIRMS (Worms for Immune Regulation in MS) study is led by Professor Cris Constantinescu and Professor David Pritchard and is a randomised, placebo controlled, phase 2 study in people with relapsing remitting MS and will be carried out at multiple centres up and down the country. The 25 worms are microscopic and are introduced painlessly through a patch in the arm. They are then flushed out after nine months. Professor Constantinescu, said: "People are really interested in this form of potential therapy because it's a natural treatment. It's been tested for safety and we now need to study the potential benefits and any side effects............." For the full report please go to MSRC: MS Research News : Endo-parasites

Epstein-Barr virus may be associated with progression of multiple sclerosis

Tue, 03 Mar 2009 02:04:00 EST

Epstein-Barr virus (EBV), the pathogen that causes mononucleosis, appears to play a role in the neurodegeneration that occurs in persons with multiple sclerosis, researchers at the University at Buffalo and the University of Trieste, Italy, have shown. Multiple sclerosis (MS) is an autoimmune disease that can cause major disability. There currently is no cure. "This study is one of the first to provide evidence that a viral agent may be related to the severity of MS disease process, as measured by MRI," said Robert Zivadinov, M.D., Ph.D., associate professor of neurology in UB's Jacobs Neurological Institute (JNI) and first author on the study. The research appears in the Online First section of the Journal of Neurology, Neurosurgery and Psychiatry. "A growing body of experimental evidence indicates that past infection with EBV may play a role in MS," said Zivadinov, "but the relationship of EBV and the brain damage that can be seen on MRI scans had not been explored." The study involved 135 consecutive patients diagnosed with MS at the Multiple Sclerosis Center of the University of Trieste. Evaluations of the MRI scans were carried out at the University of Trieste and at the JNI's Buffalo Neuroimaging Analysis Center (BNAC), which Zivadinov directs................. For the full report please go to MSRC: MS Research News : Other Conditions : Epstein-Barr Virus