EDMONTON, Alberta, March 1, 2007--On May 9th, 2006 BioMS announced enrolment of the 200th patient in its pivotal phase II/III clinical trial of MBP8298, a synthetic peptide drug for the treatment of multiple sclerosis (MS). Under the terms of the trial protocol, an interim safety and efficacy analysis will be performed on data from the first 200 patients enrolled when they have completed 24 months of the clinical trial. This interim analysis is now just 14 months away.
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Big news from BioMS!
Recently we announced two major milestones…
BioMS cleared by the FDA to initiate a pivotal phase III MS trial
What does this mean for BioMS? The clearance to proceed with a phase III trial in the U.S. is a significant step towards bringing MBP8298 to the worldwide market. There are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive MS.
Details: The trial named MAESTRO-03 will be a pivotal phase III clinical trial in the US, and will evaluate MBP8298 for the treatment of secondary progressive MS.
The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously 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), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).
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BioMS completes patient recruitment in MAESTRO-01 MS trial
What does this mean for BioMS? This brings BioMS one step closer to the objective of offering patients a safe and effective first line therapy for the treatment of secondary progressive MS.
Details: The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with SPMS. The study is being conducted at 48 sites across Canada and Europe (10 countries) and will include approximately 550 patients being administered either MBP8298 or placebo intravenously every six months for a period of two years.
To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.
For more information please contact:
BioMS Medical Corp ? Phone: 780-413-7152 ? www.biomsmedical.com or email info@biomsmedical.com
This information may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
