BioMS Medical reaches milestone in pivotal multiple sclerosis trial

By Lisa Kerner

Erie, Pa., May 9 - BioMS Medical Corp. said that more than 200 patients have been enrolled in its pivotal phase 2/3 clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis.

"This is an important milestone event as it sets the clock as to when the independent Data Safety Monitoring Board will initiate their review of the interim data and report on any significant preliminary findings," president Kevin Giese said in a company news release.

"With more than 200 patients enrolled and close to 300 patients screened to-date, our pivotal trial is progressing very well."

Patients are being enrolled at sites in Canada, the United Kingdom and Sweden in the randomized, double-blind study. A total of about 553 patients will received either MBP8298 or placebo intravenously every six months for a period of two years.

An interim safety and efficacy analysis will be performed after the patients have been in the trial for 24 months.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale, in patients with HLA-DR2 and/or HLA-DR4 immune response genes, the company said.

BioMS Medical is an Edmonton, Alta., biotechnology company engaged in the development and commercialization of novel therapeutic technologies.

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