BIOMS MEDICAL COMMENCES ENROLMENT IN A RELAPSING REMITTING MULTIPLE SCLEROSIS TRIAL
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Edmonton, Alberta, November 23, 2006 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the first patients have been enrolled in its placebo controlled multi-center Phase II clinical trial of MBP8298 for the treatment of relapsing remitting multiple sclerosis (RRMS).
“This is a major milestone in our strategy to advance our lead drug into a second indication,” said Mr. Kevin Giese, President of BioMS Medical. “MBP8298 has shown potential to significantly delay disease progression in secondary progressive MS (SPMS) patients with immune response genes HLA-DR2 and/or DR4 and we look forward to evaluating the potential efficacy of our lead drug in RRMS patients, who represent an equally large patient population.”
The fifteen month, double-blind, placebo-controlled trial will enroll up to 215 patients with RRMS from up to 30 sites. The trial will be followed by a 12 month active treatment open label extension period. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.
RRMS and SPMS each affect 40 - 45% of the estimated 2.5 million MS patients worldwide. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for up to 75% of the MS patient population.
MBP8298 is also currently undergoing a pivotal phase III trial for the treatment of secondary progressive multiple sclerosis (SPMS), with interim data from this trial anticipated in approximately 18 months.
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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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