BioMS Medical Initiates Enrollment in Pivotal Phase II/III Multiple Sclerosis Trial
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Edmonton, Alberta, December 8, 2004 - 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 pivotal Phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis which affects approximately 40% of the estimated 2.5 million MS patients worldwide.
“Today's announcement signifies a major milestone for both the advancement of our lead drug and for the worldwide MS community,” said Mr. Kevin Giese, President of BioMS Medical. “Most current and emerging therapies do not target secondary progressive MS, so for people suffering from this form of the disease, there are really limited treatment options available.”
The trial is expected to enroll up to 553 patients and will be a double-blind, placebo-controlled study involving multiple trial sites. Patients 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 the previously identified responder group, patients with immune response genes HLA-DR2 or HLA-DR4. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for up to 75% of the MS patient population.
“This trial has been designed to confirm the efficacy and safety shown by MBP8298 in previous clinical trials, particularly in patients with specific genetic profiles often associated with MS. We also anticipate gathering additional data regarding the potential of this treatment in patients with other types of MS,” said Dr. Leopold Arfors, Medical Director.
MS is an unpredictable, at times disabling disease of the central nervous system. The disease attacks the protective myelin covering of the central nervous system, causing inflammation and often destroying the myelin in patches. Canada has one of the highest rates of MS in the world.
Further information regarding the enrollment of patients can be heard on audio archive at the company's website at www.biomsmedical.com .
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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 |