There is new hope in the fight against multiple sclerosis, thanks to the ongoing success of a capital campaign raising $60 million to accelerate research and find a cure for the debilitating disease.

EndMS, organized by the Multiple Sclerosis Society of Canada, has already passed the two-thirds mark towards its fundraising goal and five regional research and training centres are operating as the hubs of a cross-country MS network.

“The society has been very far-sighted in spending its money not only on very good care but also on research,” says Queen’s University professor of neuropathology and member of the Multiple Sclerosis Society of Canada’s national board Dr. Samuel Ludwin. “But we needed to go further. A way to do this was to create a national network of combined education and position funding. The more we strengthen our research program, the more we enhance clinical care.”

“Over the 60 years that the society has been around, we have made a lot of progress and funded a lot of research,” says Stewart Wong, the MS Society’s media and public relations national senior manager. “The advances in research have translated into better treatment options for people with MS and so have enhanced their quality of life. . . . What we are trying to do here is keep the momentum and drive toward the goal of funding research so that we can find a cure.”

The endMS project, says Ludwin, brings together over 100 senior researchers and 250 trainees representing 54 Canadian institutions.

“Collaboration is critical to significant, continued success in MS research,” said Dr. Jack Antel, scientific director of the endMS Research and Training Network and clinical neurologist at McGill University, when the project was announced last fall. “When we work together, we can more clearly understand how our research findings apply to real patients and that sharing is what will continue to propel us forward toward a cure.”

Two decades ago, physicians could do little but help patients manage symptoms. But by the mid-1990s, disease-modifying Interferon drugs were being used to slow the progression of the disease.

“Those drugs can alter the course of the disease to some extent and cut down on exacerbations by 30 to 40 per cent,” says Edmonton MS specialist and University of Alberta assistant clinical professor Dr. Brad Stewart.

However, Vancouver MS specialist Dr. Stanley Hashimoto says their effectiveness was not as significant as initially believed.

“The marketing exaggerated the impact,” he says. “All of us involved in multiple sclerosis thought we needed something better. But one of the things that came out of all of it was a much greater interest in the disease. A disease that had had a very low profile now had become a high-profile disease, so a lot more money was put into looking for treatment.”

More research and new disease-modifying therapies that reduce symptoms and relapses are having a major impact on the quality of life of people with MS.

“The way I ask my patients to look at it is that the drugs they are on are good,” says Stewart. “The next ones coming up are great and the ones that are coming after that are even better. It’s an awful thing to have MS, but all the research over the last 10 or 15 years is really bearing fruit. The promise is huge.”

“If you have MS today,” says Wong, “You are in a much better place than you ever have been, not only because of the treatments that are available that were not available 15 years ago, but also because so many people are interested in the disease.”

“There’s no question that this is a better time to have MS than 20 years ago,” says Ludwin. “The frustrating thing for those of us who have been in research is that, after all this time, multiple sclerosis is still a very mysterious disease. We will not really be able to cure it until we know the absolute cause. On the other hand, we have learned so much about how the processes of MS work that all sorts of therapies are available to make life a lot more comfortable and livable for many people. The research is superb and the network is worth celebrating. We hope the answer will come with more and more research.”

—

Research underway as part of the endMS initiative includes studies on:

- Preventing autoimmunity attacks on the central nervous system

- How to stimulate re-growth and repair of myelin, the protective insulation surrounding nerve fibers in the central nervous system

- Whether transplanting bone marrow stem cells in people with MS can stop the disease

- The role of genetic susceptibility and environment

- The development of MS in children

© Copyright (c) Canwest News Service

Intensive research is leading to new hope for MS
There is new hope in the fight against multiple sclerosis, thanks to the ongoing success of a capital campaign raising $60 million to accelerate research and find a cure for the debilitating disease.EndMS, organized by the Multiple Sclerosis Society of Canada, has already passed the two-thirds mark towards its fundraising goal and five regional research and training centres are operating as the hubs of a cross-country MS network.
“The society has been very far-sighted in spending its money not only on very good care but also on research,” says Queen’s University professor of neuropathology and member of the Multiple Sclerosis Society of Canada’s national board Dr. Samuel Ludwin. “But we needed to go further. A way to do this was to create a national network of combined education and position funding. The more we strengthen our research program, the more we enhance clinical care.”
“Over the 60 years that the society has been around, we have made a lot of progress and funded a lot of research,” says Stewart Wong, the MS Society’s media and public relations national senior manager. “The advances in research have translated into better treatment options for people with MS and so have enhanced their quality of life. . . . What we are trying to do here is keep the momentum and drive toward the goal of funding research so that we can find a cure.”
The endMS project, says Ludwin, brings together over 100 senior researchers and 250 trainees representing 54 Canadian institutions.”Collaboration is critical to significant, continued success in MS research,” said Dr. Jack Antel, scientific director of the endMS Research and Training Network and clinical neurologist at McGill University, when the project was announced last fall. “When we work together, we can more clearly understand how our research findings apply to real patients and that sharing is what will continue to propel us forward toward a cure.”
Two decades ago, physicians could do little but help patients manage symptoms. But by the mid-1990s, disease-modifying Interferon drugs were being used to slow the progression of the disease.
“Those drugs can alter the course of the disease to some extent and cut down on exacerbations by 30 to 40 per cent,” says Edmonton MS specialist and University of Alberta assistant clinical professor Dr. Brad Stewart. However, Vancouver MS specialist Dr. Stanley Hashimoto says their effectiveness was not as significant as initially believed.
“The marketing exaggerated the impact,” he says. “All of us involved in multiple sclerosis thought we needed something better. But one of the things that came out of all of it was a much greater interest in the disease. A disease that had had a very low profile now had become a high-profile disease, so a lot more money was put into looking for treatment.”
More research and new disease-modifying therapies that reduce symptoms and relapses are having a major impact on the quality of life of people with MS.
“The way I ask my patients to look at it is that the drugs they are on are good,” says Stewart. “The next ones coming up are great and the ones that are coming after that are even better. It’s an awful thing to have MS, but all the research over the last 10 or 15 years is really bearing fruit. The promise is huge.”
“If you have MS today,” says Wong, “You are in a much better place than you ever have been, not only because of the treatments that are available that were not available 15 years ago, but also because so many people are interested in the disease.”
“There’s no question that this is a better time to have MS than 20 years ago,” says Ludwin. “The frustrating thing for those of us who have been in research is that, after all this time, multiple sclerosis is still a very mysterious disease. We will not really be able to cure it until we know the absolute cause. On the other hand, we have learned so much about how the processes of MS work that all sorts of therapies are available to make life a lot more comfortable and livable for many people. The research is superb and the network is worth celebrating. We hope the answer will come with more and more research.”
—Research underway as part of the endMS initiative includes studies on:
- Preventing autoimmunity attacks on the central nervous system - How to stimulate re-growth and repair of myelin, the protective insulation surrounding nerve fibers in the central nervous system - Whether transplanting bone marrow stem cells in people with MS can stop the disease - The role of genetic susceptibility and environment - The development of MS in children

© Copyright (c) Canwest News Service

Panel Of Multiple Sclerosis Experts Provides Best Practice Treatment Recommendations For Tysabri

Best-practice recommendations for the selection and management of patients with multiple sclerosis (MS) who may benefit from, or are receiving treatment with TYSABRI® (natalizumab) were published recently in a supplement to the medical journal Multiple Sclerosis. The panel provided recommendations focusing on appropriate patient selection and patient management. The recommendations, which recognize the significant efficacy of TYSABRI and the need to adequately treat patients who exhibit continued disease activity, are based on U.S. prescribing information and the panel’s vast clinical experience in treating MS patients with TYSABRI. Recommendations not only take into account the need to adequately treat patients who exhibit continued disease activity, but also the need to weigh the treatment’s benefit with potential risks.

“These best-practice approaches have been developed to ensure appropriate use of this highly-effective therapy, especially with MS patients who present with continued disease activity,” said Patricia K. Coyle, MD, professor and acting chair, department of neurology, Stony Brook University Medical Center and, director, Stony Brook MS Comprehensive Care Center, Stony Brook, New York. “The benefits of TYSABRI are evident in that it can significantly reduce relapse rates, improve cognitive and physical disability and provide freedom from disease activity for many patients, when measured by clinical and radiological measures.”

One of the expert panel’s recommendations encourages earlier and more rapid transition from first-line treatment to TYSABRI. The recommendations also seek to lower the threshold with physicians for treating unacceptable disease activity seen in their patients. According to the panel, factors such as the nature and frequency of relapses, the location of new or unresolved MRI lesions, MRI activity in the spinal cord, rapid or persistent changes in physical disability and functional deficits in cognition should be evaluated and weighed when determining the appropriate patients to treat with TYSABRI.

The panel developing the recommendations, which was selected by Biogen Idec, included U.S. academic and community neurologists who, combined, have approximately 2,000 patient-years experience with TYSABRI. The panel members were: Dr. Coyle; John F. Foley, MD, director, Rocky Mountain MS Clinic, Rocky Mountain Neurological Associates; Edward Fox, MD, director, MS Clinic of Central Texas, and clinical assistant professor, University of Texas Medical Branch; Douglas R. Jeffery, MD, PhD, associate professor, department of neurology, Wake Forest University Baptist Medical Center; Frederick E. Munschauer III, MD, professor and chairman, department of neurology, State University of New York at Buffalo, and chief, The Jacobs Neurological Institute; and Carlo Tornatore, MD, associate professor, department of neurology, and director, Multiple Sclerosis Center, Georgetown University Medical Center.

The paper entitled “Best Practice Recommendations for the Selection and Management of Patients with MS Receiving Natalizumab Therapy” is one of four articles that are part of a supplement being published in the journal Multiple Sclerosis. The other papers are “Introduction to Best Practice Recommendations for the Selection and Management of Patients with MS on Natalizumab,” “Clinical Efficacy and Benefit of Natalizumab” and “Clinical Vigilance for PML in the Context of Natalizumab.” The supplement was funded by Biogen Idec and Elan Corporation, plc.

About TYSABRI

TYSABRI is approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate, when compared with placebo, and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSBARI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc.

Source:
Shannon Altimari
GCI Health

Specific Study Information

The Rocky Mountain MS Center at Anschutz Medical Campus is looking for women with relapsing remitting MS for a 24 -month study to see if there are fewer relapses with the treatment of

Copaxone injections plus oral estriol as compared to the treatment of Copaxone injections plus oral

placebo. There will be no patients receiving only placebo in this trial. They will all receive Copaxone.

To be eligible for this study you must:

Be female, between 18 and 50 years old;

Be diagnosed with definite RRMS.

Be able to walk without any aids such as cane or walker;

Have had at least one relapse within the last 2 years;

Be able to travel to the Rocky Mountain MS Center at Anschutz Medical Campus for a

number of study visits.

You are not eligible for the study if you are pregnant, breast-feeding, smoke, or have other serious

medical conditions. Previous treatment with Copaxone or an interferon (Avonex, Rebif,

Betaseron) are allowed.

If you are interested in this study in particular, please email neurology.msresearch@ucdenver.edu

or call 303-724-4644 for further information and a 20-minute telephone screening to determine

initial eligibility for the study.

Specific Study InformationThe Rocky Mountain MS Center at Anschutz Medical Campus is looking for women with relapsingremittingMS for a 24 -month study to see if there are fewer relapses with the treatment ofCopaxone injections plus oral estriol as compared to the treatment of Copaxone injections plus oralplacebo. There will be no patients receiving only placebo in this trial. They will all receive Copaxone.To be eligible for this study you must:Be female, between 18 and 50 years old;Be diagnosed with definite RRMS.Be able to walk without any aids such as cane or walker;Have had at least one relapse within the last 2 years;Be able to travel to the Rocky Mountain MS Center at Anschutz Medical Campus for anumber of study visits.You are not eligible for the study if you are pregnant, breast-feeding, smoke, or have other seriousmedical conditions. Previous treatment with Copaxone or an interferon (Avonex, Rebif,Betaseron) are allowed.If you are interested in this study in particular, please email neurology.msresearch@ucdenver.eduor call 303-724-4644 for further information and a 20-minute telephone screening to determineinitial eligibility for the study.

Biogen Idec’s oral compound BG-12 achieves development milestones in MS and RA

CAMBRIDGE, Mass. –

December 7, 2009 –

Biogen Idec (NASDAQ: BIIB) today announced that its oral compound BG-12 (dimethyl fumarate) achieved key milestones in clinical trials for multiple sclerosis (MS) and rheumatoid arthritis (RA). In recent months, the last patient was enrolled in the CONFIRM trial, the second of two Phase III trials designed to evaluate the efficacy and safety of BG-12 as a monotherapy in patients with relapsing-remitting multiple sclerosis (RRMS). Both the DEFINE and CONFIRM Phase III trials are now fully enrolled and will evaluate the effect of BG-12 on clinical relapse, disability progression, various MRI measures of disease activity, and safety.

The last patient was also enrolled in a Phase II study to evaluate the safety, tolerability and efficacy of BG-12 in combination with methotrexate in subjects with active RA who had an inadequate response to conventional disease-modifying antirheumatic drug (DMARD) therapy.

“There is significant unmet need in both the MS and RA communities for additional treatment options,” said Kate Dawson, M.D., senior director, Medical Research, Biogen Idec. “The Phase IIb study of oral BG-12 in patients with MS showed promising MRI results regarding the compound’s ability to reduce inflammation and its potential for neuroprotection. We look forward to results from the DEFINE and CONFIRM Phase III MS studies, as well as the proof-of-concept trial in RA.”

BG-12 has been shown to activate the Nrf2 transcriptional pathway, which pre-clinical studies have shown defends against oxidative-stress induced neuronal death, protects the blood-brain barrier and supports maintenance of myelin integrity in the central nervous system. Central nervous system inflammation and damage may trigger the symptoms common in RRMS such as fatigue, cognitive deterioration and physical disability. Because of BG-12’s unique effect on the Nrf2 pathway and its oral delivery, BG-12 is also being considered for future MS combination therapy studies.

Additionally, as an oral compound, BG-12 holds promise for patients with RA. Its combination of anti-inflammatory and potential cytoprotective properties support the compound’s evaluation in RA.

BG-12 is an oral formulation of dimethyl fumarate. Fumaderm®, a therapeutic for the treatment of psoriasis in Germany, includes dimethyl fumarate as one of the active ingredients. Fumaderm has more than 14 years of post-marketing experience and approximately 100,000 patient years of use.

###

About DEFINE and CONFIRM

DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS) is a two-year, randomized, double-blind, placebo-controlled, dose-comparison study of 240 mg BID or TID of BG-12 orally compared to placebo in 1,200 patients with RRMS.

CONFIRM (COmparator and aN oral Fumarate In Relapsing-remitting MS) is a two-year, randomized, placebo-controlled and active reference comparison study in more than 1,400 patients with RRMS. In the three-arm study, patients are randomized to 240 mg BID or TID of BG-12 orally, placebo capsules orally, or 20 mg of Copaxone® (glatiramer acetate) via subcutaneous injection.

These Phase III, global, multi-center trials are being conducted in more than 300 centers in N. America, Europe and throughout the world.

About the RA Phase II Study

The proof-of-concept RA study (109RA201) is a randomized, double-blind, placebo-controlled, multiple-dose study in 150 patients with active RA who have had an inadequate response to conventional DMARD therapy. Patients are randomized to receive 240 mg BID or TID of BG-12 orally compared to placebo. All patients will receive background methotrexate therapy.

About BG-12

BG-12 (BG00012, dimethyl fumarate) is an investigational oral therapy in Phase III clinical development for the treatment of RRMS, the most common form of MS, and in Phase II for RA. BG-12 received Fast Track designation in MS from the U.S. Food and Drug Administration (FDA), which may expedite U.S. regulatory review. Biogen Idec retains full worldwide commercial rights to BG-12.

The Phase IIb study of BG-12, which was published in the Lancet, showed that BG-12 reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with RRMS when compared to treatment with placebo (p<0.0001). The presence of Gd+ lesions is thought to indicate continuing inflammatory activity within the central nervous system. Results from this study stimulated further evaluation of BG-12’s potential for neuroprotection. BG-12 is the first compound in trials for the treatment of MS that has been shown to activate the Nrf2 pathway.

About MS

MS is a chronic, unpredictable and progressive disease of the central nervous system that causes inflammation and destruction of the myelin sheath – the protective layer that surrounds the body’s nerve fibers. This destruction may result in cognitive impairment, physical disability and fatigue. According to the National MS Society, MS affects about 400,000 people in the U.S. and more than 2.5 million people worldwide. RRMS affects about 85 percent of the MS population. RRMS is characterized by clearly defined flare-ups followed by periods of partial or complete recovery or remission.

About RA

RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans. It generally presents between the ages of 25 and 55, and is more common in women than men. The damage that occurs in RA often results in disability and is a result of the immune system attacking joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Biogen Idec Safe Harbor

This press release contains forward-looking statements regarding the development of BG-12 as a potential treatment for various indications. These statements are based on the company’s current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the company’s current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information, further studies, or may fail to approve the drug, or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec’s drug development and other activities, read the Risk Factors section of the most recent periodic report filed by Biogen Idec with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Multiple Sclerosis and Pregnancy

ScienceDaily (Nov. 19, 2009) —

There is good news for women with multiple sclerosis (MS) who are pregnant or thinking about becoming pregnant. A new study shows that pregnant women with multiple sclerosis are only slightly more likely to have cesarean deliveries and babies with a poor prenatal growth rate than women who do not have MS.

Plus, the women with MS were no more likely to have other pregnancy problems, such as pre-eclampsia and other high blood pressure problems and premature rupture of membranes, than women in the general population. The study is published in the November 18, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology.

The large study used a national database from all non-federal short-stay hospitals in 38 states. The data included an estimated 18.8 million deliveries, with about 10,000 of those occurring in women with MS.

The women with MS were more likely than women without chronic medical conditions (2.7 percent for women with MS compared to 1.9 percent for women without chronic medical conditions) to have a fetus with intrauterine growth restriction, defined as a weight less than the tenth percentile for the gestational age, as measured by ultrasound. Women with MS were more likely to have a cesarean delivery than those in the general population (42 percent versus 33 percent).

“These results are reassuring for women with MS,” said study author Eliza Chakravarty, MD, MS, of Stanford University School of Medicine in Stanford, CA. “Women and their doctors have been uncertain about the effect of MS on pregnancy, and some women have chosen to delay or even avoid pregnancy due to the uncertainty. We found that women with MS did not have an increased risk of most pregnancy complications.”  Chakravarty said that previous studies on MS and pregnancy have focused on the impact of pregnancy on disease activity.

The study also looked at women who had diabetes prior to becoming pregnant (not gestational diabetes), and found that they had higher rates of complications than women with MS and high rates of complications in areas where the women with MS did not have increased rates.

Good News on Multiple Sclerosis and Pregnancy
ScienceDaily (Nov. 19, 2009) —
There is good news for women with multiple sclerosis (MS) who are pregnant or thinking about becoming pregnant. A new study shows that pregnant women with multiple sclerosis are only slightly more likely to have cesarean deliveries and babies with a poor prenatal growth rate than women who do not have MS.
Plus, the women with MS were no more likely to have other pregnancy problems, such as pre-eclampsia and other high blood pressure problems and premature rupture of membranes, than women in the general population. The study is published in the November 18, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology.
The large study used a national database from all non-federal short-stay hospitals in 38 states. The data included an estimated 18.8 million deliveries, with about 10,000 of those occurring in women with MS.
The women with MS were more likely than women without chronic medical conditions (2.7 percent for women with MS compared to 1.9 percent for women without chronic medical conditions) to have a fetus with intrauterine growth restriction, defined as a weight less than the tenth percentile for the gestational age, as measured by ultrasound. Women with MS were more likely to have a cesarean delivery than those in the general population (42 percent versus 33 percent).
“These results are reassuring for women with MS,” said study author Eliza Chakravarty, MD, MS, of Stanford University School of Medicine in Stanford, CA. “Women and their doctors have been uncertain about the effect of MS on pregnancy, and some women have chosen to delay or even avoid pregnancy due to the uncertainty. We found that women with MS did not have an increased risk of most pregnancy complications.”  Chakravarty said that previous studies on MS and pregnancy have focused on the impact of pregnancy on disease activity.
The study also looked at women who had diabetes prior to becoming pregnant (not gestational diabetes), and found that they had higher rates of complications than women with MS and high rates of complications in areas where the women with MS did not have increased rates.