MS drug with unusual history shows promise

By Miriam Falco,CNN

(CNN) Achemical that can be used as a food additive, caused serious skin infections after people sat on sofas treated with it and was approved as a psoriasis treatment in Germany 15 years ago, may prove to be a viable treatment option for people with the relapsing-remitting form of multiple sclerosis (MS).

Its true.

Dimethyl fumarate also known so far as BG-12 could be another weapon in a neurologists arsenal to treat the disease, if the drug is approved. Based on the results of two large studies published in the New England Journal of Medicine, experts believe this is likely.

More than 2 million people around the world live with MS, a disease where the bodys immune system attacks the patients central nervous system and destroys the myelin, or sheath, protecting nerve cells. Most people are diagnosed between the ages of 20 and 50, and more women than men are affected, according to the National MS Society. As the disease progresses, it can become quite debilitating, leading to numbness and difficulty walking and seeing among many other symptoms.

Relapsing MS is a disease that we have treatments for, but theyre really on two ends of the spectrum, says Dr. Robert Fox, a neurologist at the Mellen Center for MS at the Cleveland Clinic. We have injection treatments that have modest efficacy. They reduce relapses by about 30%.

And we have very effective therapies, but they are infusion therapies and they have risk risks of a brain infection that may be fatal, Fox says. This new treatment offers the opportunity for sort of the best of both worlds, in that it has very good efficacy, but its in the form of a pill and appears to have much reduced risk than other therapies.

Fox, who is the lead author of one of the studies, says both studies published Wednesday were designed in the same way so their results could be examined together. Both were large trials involving more than 1,400 patients in many countries and both compared BG-12 to a placebo a common scenario when seeking drug approval.

He says both studies showed BG-12 reduced the number of relapses, reduced the number of lesions or scars on the brain and progression of disability and was more effective than standard injectable MS drugs.

Both studies found BG-12 was well tolerated and seems to be safe. They looked at taking the pill two and three times day. Fox says between the two studies, taking the pill three times a day wasnt significantly better than twice a day, which is why the FDA drug approval application only refers to twice daily dosing.

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MS drug with unusual history shows promise