Guest guest Posted December 9, 2004 Report Share Posted December 9, 2004 BioMS Medical initiates enrollment in pivotal Phase II/III multiple sclerosis trial Toronto Stock Exchange Symbol: MS EDMONTON, Dec. 8 /PRNewswire-FirstCall/ - 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. 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 http://www.biomsmedical.com About BioMS Medical Corp. ------------------------- BioMS Medical Corp. is a biotechnology company dedicated to the development and commercialization of innovative therapies. BioMS Medical's lead drug, MBP8298, is a patented technology for the treatment of multiple sclerosis and is currently in a pivotal Phase II/III clinical trial. The Company is poised to initiate a Phase I clinical trial for HYC750, a therapeutic designed to mobilize stem cells and neutrophils for the treatment of cancer therapy related side-effects. BioMS also has an equity interest in BioCyDex, a private company developing technology for the delivery and imaging of genes in cells. This news release may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly. SOURCE BioMS Medical Corp. More news from PR Newswire...Issuers of news releases and not PR Newswire are solely responsible for the accuracy of the content.Terms and conditions, including restrictions on redistribution, apply.Copyright © 1996-2004 PR Newswire Association LLC. .A United Business Media company. Quote Link to comment Share on other sites More sharing options...
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