Research Advocate
Encouraging Results for New MS Treatments!
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While these results are very encouraging, alemtuzumab is an antibody that manipulates the immune system and can cause very serious side effects, in particular a rare blood condition called immune thrombocytopenic purpura (ITP) that can lead to abnormal bleeding and even death. Six patients developed ITP during the trial, and one died. Genzyme temporarily stopped the trial after the death and started closely monitoring all patients on the treatment for ITP, which can be reversed if treated promptly. Phase 3 trials are now getting underway, and if the already observed results hold up, alemtuzamab given just once a year may be a very promising treatment that when given early on in the disease, can stop progression and reverse damage. To learn more about enrolling in these trials, call the CARE-MS Call Center, 888-415-MS-CARE
The potential for treating MS with orally administered compounds is also showing great promise for treating relapsing-remitting MS (RRMS). Phase 2 clinical trials on oral laquinimod (Teva Pharmaceuticals) administered daily demonstrated a significant reduction in MRI disease activity in RRMS patients. In addition, the study showed a favorable trend toward reducing annual relapse rates and the number of relapse-free patients. This treatment is generally well tolerated and is being further studied. Investigators worldwide, including sites in New Hampshire and New York are seeking volunteers for phase 3 clinical trials on oral laquinimod. To find out more about these trials, visit tevaclinicaltrials.com or call 1-800-840-5601.
Oral cladribine (EMD Serono) and dimethy fumarate (Biogen Idec) are other promising oral therapies well into phase 2 and phase 3 studies.
Investigators Find No Overall Link Between Hepatitis B Vaccine and MS
A study evaluating the potential that hepatitis B vaccination increases the risk of developing MS found no general increase in risk from exposure to the vaccine. However, the investigators did find a possible hint that a specific brand of the vaccine may increase the risk of MS, but that finding requires confirmation. The study, led by Yann Mikaeloff, MD, PhD, evaluated vaccination records of 349 children in France who had experienced a neurologic episode.
The World Health Organization and, separately, the Institute of Medicine reviewed all available data and concluded that there was no association between hepatitis B and MS.
Future studies should determine any differences between vaccination brands, but hepatitis B is a serious disease and people should not translate these findings into a reason not to protect themselves against it.
$5 Million Awarded to New MS Research Program
$5 million has been awarded for a historic MS research project within the Congressionally Directed Medical Research Programs (CDMRP), thanks in large part to the tireless work of MS activists across the country who helped to secure the funding.
This is a tremendous victory for the MS movement as it is the first time that multiple sclerosis has ever received its own line item allocation under CDMRP, a program funded through the Defense Department. The new program is listed in a multi-functional funding package that Congress approved, which includes the defense and homeland security appropriation bills, plus a continuing resolution that keeps the government operating until March of next year.
The establishment of this new avenue of research funding for MS is a vivid example of the power of advocacy and the influence of a grass roots campaign. This movement took impetus in the fall of 2006 when MS activists went door to door and engaged online tools to collect more than 100,000 signatures supporting a research program for MS within the CDMRP.
FDA Agrees to Fast Review for Drug Being Tested for MS
It was announced by the drug maker BioMS Medical Corp. (Edmonton, Alberta) that dirucotide (also known as MBP8298) has been designated by the U.S. Food and Drug Administration as a “Fast Track Product.” This designation should expedite its future review by the FDA after the sponsor submits results of current trials now underway.
Dirucotide is a synthetic fragment of myelin basic protein (MBP, a component of myelin), which reduces the production of spinal fluid antibodies that react against MBP during the immune attack on the brain and spinal cord that occurs in MS. The drug, which is delivered intravenously, is currently under study in two studies in secondary-progressive MS and one study in 218 people with relapsing-remitting MS. All studies are fully enrolled.
An earlier study of dirucotide showed a statistically significant delay in clinical progression among individuals with certain genetically determined “HLA” types. HLA is a molecular tag located on body cells that helps the immune system attack foreign invaders and, in the case of autoimmune diseases, the body’s own tissues.
First World Congress on MS
In mid-September, nearly 5,200 clinicians, clinical researchers, and basic scientists gathered in Montreal, Quebec, from around to world for the first World Congress on Treatment and Research in Multiple Sclerosis, the largest international conference on MS research and treatment in 2008.
The first day of the World Congress provided an early glimpse of the nearly 1,000 studies being presented at the conference all focused on many of the most important topics in the field of multiple sclerosis, including cognitive and emotional problems that are common in people with MS, the notorious unpredictability of MS, and the incapability of the central nervous system to repair itself in people with MS.
The Atlas of MS, providing data on MS around the world, was introduced on the second day of the first World Congress on Treatment and Research in MS, along with new strategies to repair MS damage, new data on children with MS, and updates on alternative interventions.
Presentations from leading MS researchers during the third day of this unprecedented gathering highlighted the changing landscape of MS, new insights into risk factors and progress in the search for better treatments. A lecture by Chris Polman, MD, (Free University, The Netherlands) explored concepts related to what has been and can be learned from treating MS and its animal models, even from studies that are unsuccessful, and the opportunities for deeper understanding of the disease presented by both large-scale and small clinical studies.
The final day of the congress featured progress understanding cognitive function and rehabilitation as well as late-breaking research on new therapies and new approaches to studying MS. The Leonor Gold Memorial Lecture by Nora Fernandez Liguori, MD, explored the history, promise and issues related to neurorehabilitation for treating cognitive dysfunction that results from MS.
The four days of the World Congress offered an impressive glimpse into the fast-moving progress being made by investigators around the world, in many different fields, toward better treatments and quality of life, prevention and a cure for multiple sclerosis.
Society-funded Researchers Find Pattern of Gene Activity Associated with High Risk for MS
In a major step toward discovering molecules that may be used as “markers” to predict MS disease activity and progression, researchers identified a pattern of genes being turned on or off within immune cells that was associated with quick conversion to MS in a study of 37 people with CIS (clinically isolated syndrome, a first event suggestive of MS).
MS occurs when the immune system attacks the brain and spinal cord. Previous research suggests that about one-third of patients who experience CIS, a single event denoting inflammatory damage to myelin in the brain or spinal cord, will “convert” to definite MS within one year, meaning that they will experience subsequent events and signs that make it possible to make a definite diagnosis of MS. That’s why identifying markers - such as patterns of genetic activity - in people at high risk for MS or in the earliest stages of the disease would be invaluable in assisting patients and clinicians to determine the best treatment options. This study is a step toward making MS predictable and preventable.
MS and the Role of Genetics Study Opportunity
On Sunday, October 26, in Portsmouth, N.H., Dr. DeJager from Partners Multiple Sclerosis Center, Brigham and Women’s Hospital and the Harvard Medical School presented on the role of genetics in multiple sclerosis to 60 people gathered to learn about and participate in the ongoing multi-center research into the underlying genetic causes of MS. The goal of the study is to identify which genes, or which combination of genes, make a person more susceptible to MS. More than 30 attendees joined the study that day and donated blood samples to the research staff on hand. Almost as many signed up to join the study and took materials home to provide blood samples in their own communities. This study is ongoing and continues to enroll both people with MS and healthy control subjects, most specifically biological parents of a person diagnosed with MS.
TO BECOME A PARTICIPANT:
- Diagnosed with MS or other demyelinating disease by your neurologist
- Biological parent of a person diagnosed with MS
- Are at least 18 years of age
WHAT IS INVOLVED?
A blood sample from the person with MS and, if possible, both biological parents. The inability of either or both parents to contribute to the study does not exclude you from participation.
A detailed neurological history and a review of medical charts. Parents or other healthy control subjects will be required to fill out a medical history questionnaire.
FOR MORE INFORMATION OR TO GET INVOLVED?
Please contact Becky Briskin, Research Coordinator at 1-617-525-4460 or by email at rbriskin@partners.org. More information is also available in the Current Studies and Clinical Trials section.
Research in Central New England
The National MS Society is the largest private sponsor of MS research in the world. We support research and training projects aimed at finding the cause of MS, better treatments, and a cure. The MS Society also identifies promising areas of research and promotes activity in those areas.
To find a clinical trial that is recruiting near you, go to www.nationalmssociety.org/research
Local Clinical Trials Recruiting Patients
Please note: To participate, you may have to reside near the facility, as treatment and follow-up visits will be necessary throughout the course of the study. Also, please keep in mind that clinical trials often have strict criteria for enrollment, specifying the type of people (disease type, duration, age, etc.) they are seeking to participate. These help to ensure that the results will be as reliable and as effective as possible. If you are interested in participating in a clinical trial we encourage you to discuss the possibility with your personal physicians. Additional studies are listed at the chapter website our national website.
Agent: Ocrelizumab (Genentech, Inc.)
Study Purpose: A randomized, parallel-group, partially blinded, study to evaluate the effectiveness of and safety of 2 dose regimens of ocrelizumab, in comparison with Avonex® (interferon beta) and placebo.
Type of MS: RRMS
Questions and Enrollment Information:
- Site: Dartmouth Hitchcock Medical Center, Lebanon, N.H.
- Contact: Kathleen Ryan (603)653-9919, kathleen.a.ryan@hitchcock.org
Agent: Atacicept (EMD/Merck Serono, Inc.)
Study Purpose: A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and effectiveness of three doses of atacicept, a molecule that blocks immune B cell activity.
Type of MS: RR
Questions and Enrollment Information:
- Site: Dartmouth Hitchcock Medical Center, Lebanon, N.H.
- Contact: Kathleen Ryan (603)653-9919, kathleen.a.ryan@hitchcock.org