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Monday, November 13, 2006
"Research Highlights" from the New York City Chapter of the National Multiple Sclerosis Society
Positive Results for Fampridine
Acorda Therapeutics announced positive results of a Phase 3, controlled clinical trial of Fampridine-SR, an oral drug designed to provide symptomatic relief by compensating for lost nerve conduction. The placebo-controlled study involved 301 patients with all types of multiple sclerosis at 33 sites in the U.S. and Canada. The primary outcome measured was improvement in the time it took to walk 25 feet. According to the company, those on active treatment showed an average increase in walking speed of 25% versus those on inactive placebo.
The company is expected to meet with the FDA to determine next steps.
“If the FDA agrees that Fampridine is safe and effective, it would bring a welcome symptomatic therapy that has potential utility for a large number of people with different types of MS,” said John R. Richert, MD, vice president of research and clinical programs for the National MS Society.
FDA Agrees to Fast Review for Oral Cladribine
Drug maker Serono (Geneva) announced that oral cladribine, now being tested in an international Phase 3 clinical trial, 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 and, if the pill proves to be safe and effective, speed the day when there is an oral therapy for treating multiple sclerosis.
Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS.
Vitamin B3 Protects Further Nerve Tissue Damage
Researchers report that treatment with nicotinamide, a form of vitamin B3, prevented damaged nerve fibers from degenerating further in a mouse model of MS. Shinjiro Kaneko, MD, and colleagues (Children's Hospital Boston) report their findings in the September 20 issue of the Journal of Neuroscience (2006;26: 9794-9804). This study was partly funded by a research grant from the National MS Society to Zhigang He, PhD, and by the National Institutes of Health.
The immune attack in MS injures myelin, the insulation that speeds nerve impulse conduction between nerve cells. The underlying, wire-like nerve fibers, or axons, are also damaged. Finding treatments to protect axons is crucial – researchers believe that it is this damage that underlies the progression of disability in MS.
Further testing is needed before these findings can be applied to developing a possible therapy for people with MS.
We hope that you are both informed and encouraged by the innovative research projects highlighted in this issue. Breakthrough research is paying off with new treatments and better methods of diagnosis, rehabilitation and symptom management - bringing us closer to ending the devastating effects of MS.
Positive Results for Fampridine
Acorda Therapeutics announced positive results of a Phase 3, controlled clinical trial of Fampridine-SR, an oral drug designed to provide symptomatic relief by compensating for lost nerve conduction. The placebo-controlled study involved 301 patients with all types of multiple sclerosis at 33 sites in the U.S. and Canada. The primary outcome measured was improvement in the time it took to walk 25 feet. According to the company, those on active treatment showed an average increase in walking speed of 25% versus those on inactive placebo.
The company is expected to meet with the FDA to determine next steps.
“If the FDA agrees that Fampridine is safe and effective, it would bring a welcome symptomatic therapy that has potential utility for a large number of people with different types of MS,” said John R. Richert, MD, vice president of research and clinical programs for the National MS Society.
FDA Agrees to Fast Review for Oral Cladribine
Drug maker Serono (Geneva) announced that oral cladribine, now being tested in an international Phase 3 clinical trial, 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 and, if the pill proves to be safe and effective, speed the day when there is an oral therapy for treating multiple sclerosis.
Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS.
Vitamin B3 Protects Further Nerve Tissue Damage
Researchers report that treatment with nicotinamide, a form of vitamin B3, prevented damaged nerve fibers from degenerating further in a mouse model of MS. Shinjiro Kaneko, MD, and colleagues (Children's Hospital Boston) report their findings in the September 20 issue of the Journal of Neuroscience (2006;26: 9794-9804). This study was partly funded by a research grant from the National MS Society to Zhigang He, PhD, and by the National Institutes of Health.
The immune attack in MS injures myelin, the insulation that speeds nerve impulse conduction between nerve cells. The underlying, wire-like nerve fibers, or axons, are also damaged. Finding treatments to protect axons is crucial – researchers believe that it is this damage that underlies the progression of disability in MS.
Further testing is needed before these findings can be applied to developing a possible therapy for people with MS.
We hope that you are both informed and encouraged by the innovative research projects highlighted in this issue. Breakthrough research is paying off with new treatments and better methods of diagnosis, rehabilitation and symptom management - bringing us closer to ending the devastating effects of MS.