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

BioMS Medical Advances Regulatory Process for MS Drug

- MBP8298 pre-CTA package submitted to Health Canada -

Edmonton, Alberta, November 18, 2003 - BioMS Medical Corp (TSX: MS) today announced it has submitted its pre-CTA (Clinical Trial Application) information package for its lead product, MBP8298, a novel proprietary peptide therapeutic for the treatment of secondary progressive multiple sclerosis (MS), to the Therapeutic Products Directorate of Health Canada for discussion.

"Initiating a formal dialogue with Health Canada is an important milestone in our regulatory strategy for MBP8298," said Kevin Giese, President of BioMS Medical. "We look forward in the year ahead to gaining the approval we seek to initiate a pivotal human clinical trial for this important drug and commencing the trial."

MBP8298 is a synthetic peptide therapeutic for the treatment of MS that has undergone over 10 years of clinical study, successfully completing Phase I and II trials. In a double-blinded Phase II clinical trial, MBP8298 was shown over a two year period to delay the progression of the disease in 100% of patients with either HLA-DR2 or HLA-DR4 immune response genes, whereas 60% of patients on placebo had disease progression (p=0.01). HLA-DR2 is the genetic marker most clearly associated with susceptibility to MS, with approximately 75% of the estimated 2 million MS patients worldwide carrying either HLA-DR2 or HLA-DR4 genes.

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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