BioMS Medical Recieves UK Approval for Pivotal Multiple Sclerosis Trial
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Edmonton, Alberta, December 10, 2004 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced it has received a Notice of Acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its pivotal Phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).
“With this approval, we will now be able to expand our recently initiated pivotal SPMS trial beyond Canada into the United Kingdom, another jurisdiction with a significant MS population,” said Kevin Giese, President of BioMS Medical. “This approval is an important milestone in our strategy for developing MBP8298 on an international basis, with the goal of incorporating additional territories moving forward.”
The trial is a double-blind, placebo-controlled study involving up to 553 patients in both countries combined. Patients will be administered either MBP8298 or placebo intravenously every six months for a period of two years. While SPMS patients with any genetic profile will be included, the primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by the Expanded Disability Status Scale (EDSS) in the previously identified responder group, patients with immune response genes HLA-DR2 or HLA-DR4. Patients with these immune response genes account for up to 75% of the MS patient population.
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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 Director Investor Relations Phone: 780-413-7152 astadel@biomsmedical.com |
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