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news.Canadian biotech firm BioMS Medical Corp has announced that nine clinical trial sites in Canada are now recruiting patients for its phase II/III study of MBP8298, a possible treatment for secondary progressive multiple sclerosis.
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Patient enrollment for the study began in Canada in December 2004, with the first patients being dosed in January 2005.
BioMS anticipates that 30 trial sites will ultimately participate in the clinical trial. A total of 12 sites are eventually expected to become involved in Canada with a further 11 predicted for the UK and seven in two additional European countries. BioMS is currently awaiting regulatory clearance to expand the trial into these jurisdictions. The company anticipates announcing principal investigators for these countries in the near term.
Kevin Giese, president of BioMS Medical stated, “support for the trial from the MS community in both Canada and across Europe has been extremely positive.” He expects enrolment of the total 553 patients to be achieved before the end of this year: “with the pace at which patient enrollment is proceeding and clinical sites are coming online, we expect to reach our target of full enrollment for this trial by the end of 2005.”
The randomized, double-blind trial will involve the intravenous administration of either MBP8298 or placebo to patients every six months for a period of two years. 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 (EDSS).