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BioMS Multiple Sclerosis Drug Performs Well in Phase II Trial

http://www.medscape.com/viewarticle/456151

May 23, 2003
Reuters Health
New York

Canadian drug developer BioMS Medical Corp. said on Friday that final data from a 4-year phase II study indicate that its investigational multiple sclerosis (MS) drug MBP8298 is able to delay the progression of the disease, with particular efficacy in a genetic sub-population.

According to BioMS, MBP8298 contains the same amino acids found on nerves' myelin sheaths that an MS patient's immune system targets using B cell antibodies. The drug is believed to be able to absorb the antibodies and slow down their production.

The 32 patients enrolled in the phase II trial, said BioMS, were given either 500 mg of MBP8298 intravenously or placebo every 6 months for 2 years. Patients were then moved over to open-label treatment for an additional 2 years.

At the end of the first portion of the trial 5 of the 16 patients receiving the drug experienced disease progression versus 9 of the 16 patients receiving placebo.

When examining a sub-population of the trial participants who carry HLA-DR2 or HLA-DR4, genes BioMS said are common to about 75% of MS patients and associated with the production of the myelin sheath-targeting antibodies, MBP8298 stopped progression in all 10 patients receiving the drug compared with 6 of 10 patients taking placebo.

After the open-label phase of the trial, three of the HLA-DR2/DR4 patients receiving MBP8298 had progressed, said BioMS.

The company said that it has already begun preparing the regulatory submissions needed to begin a phase III study of MBP8298, which is expected to start by year-end.

BioMS spokesman Ryan Giese told Reuters Health that the 2- to 4-year trial will be conducted in Canada, and will enroll between 200 and 400 MS patients. He added that the company plans to expand phase III studies into the U.S. and Europe once additional capital can be raised.
 

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