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MS TSX: Quote: 2.65 | Change: 0.00 | 11.17.08 | 13:07:00 MST

BioMS Medical Receives Health Canada Clearance for Pivotal Phase II/III Multiple Sclerosis Trial

Edmonton, Alberta, June 7, 2004 – BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), announced that it has received Health Canada clearance to initiate a pivotal Phase II/III human clinical trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive multiple sclerosis (SPMS).

As a pivotal Phase II/III, the trial includes the Phase III testing for efficacy of MBP8298 on established clinical endpoints in a large group of patients that would be supportive of market authorization of the drug. Furthermore, the incorporation of Phase II endpoints will provide BioMS Medical with a unique opportunity to gather data on emerging MRI imaging and immunological endpoints associated with SPMS.

“We believe that BioMS has both the opportunity and the obligation to support the research that we hope will extend our understanding of SPMS and perhaps lead to new insights into the causes of MS” said Kevin Giese, President and CEO of BioMS Medical. “We are also very excited in that Health Canada clearance uniquely positions BioMS Medical with a pivotal trial for SPMS patients, a market segment for which there are few therapeutic options.” The double blind, placebo controlled trial will enroll up to 553 patients at multiple sites. Patients will receive intravenous injections every 6 months for a period of two years. The primary endpoint will be time to disease progression as determined by the Expanded Disability Status Scale (EDSS). The trial is designed with two planned interim analyses.

Further information regarding the clinical trial clearance from Health Canada can be heard on audio archive at the company's website at www.biomsmedical.com .

About Multiple Sclerosis

Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 50,000 in Canada, 350,000 – 400,000 in the United States and over 450,000 in Western Europe. MS is a disease of the central nervous system, characterized by episodes of paralysis, blindness, sensory disturbances and cognitive impairment. Almost half of all MS patients have the Secondary Progressive form of the disease.

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.

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

 

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