BioMS Medical Receives Approval to Extend Pivotal Multiple Sclerosis Trial Into Sweden
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Edmonton, Alberta, August 23, 2005 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Swedish Medical Products Agency (MPA) for its pivotal Phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).
“We are very pleased to expand this trial into Sweden. Sweden has a higher prevalence of MS, similar to that of the U.K., Canada and the northern U.S. and as a result, the country conducts leading edge research on the disease. This is an important opportunity for us to conduct our trial in another population where clinicians have extensive experience with MS and where there is a large unmet need for an effective treatment,” said Kevin Giese, President of BioMS Medical. “We anticipate a lead investigator for Sweden will be announced shortly and that the first patients from Sweden will be enrolled into the trial in the coming months.”
The trial, which is currently enrolling patients in Canada and the U.K. is a double-blind, placebo-controlled study involving up to 553 patients. 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 Investor Relations Manager Phone: 780-413-7152 astadel@biomsmedical.com |