BioMS Medical Provides Update for Pivotal Multiple Sclerosis Trial
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- Company selects 30 trial sites across Canada and Europe -
Edmonton, Alberta, April 21, 2005 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that 9 clinical trial sites in Canada are now active and recruiting patients for its pivotal Phase II/III clinical trial of MBP8298 for the treatment of secondary progressive MS. Patient enrollment 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. Across Canada, 12 sites have been selected of which 9 are active in: Vancouver, Edmonton, Calgary, Winnipeg, Toronto (two sites), Ottawa, Quebec City and Saint John’s. Regulatory clearance has been received to expand the trial into the UK and 11 trial sites have been selected to participate. An additional 7 sites have expressed interest in two additional European countries, and BioMS is awaiting regulatory clearance to expand the trial into those jurisdictions The Company anticipates announcing principal investigators for these countries in the near term.
“Support for the trial from the MS community in both Canada and across Europe has been extremely positive,” said Kevin Giese, President of BioMS Medical. “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 is expected to enroll up to 553 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).
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This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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| Ryan Giese VP Corporate Communications Phone: 780-413-7152 rgiese@biomsmedical.com |
Tony Hesby Executive VP Corporate Affairs Phone: 780-413-7152 thesby@biomsmedical.com |
Amanda Stadel Investor Relations Manager Phone: 780-413-7152 astadel@biomsmedical.com |