MBP8298 pre-CTA package submitted to Health Canada
Tuesday November 18, 2003
Source: BioMS Medical Corp
BioMS Medical Corp 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(equal sign)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.
About Multiple Sclerosis
Multiple sclerosis (MS) is one of the most common diseases of the central nervous system. MS is believed to be an autoimmune disease whereby the myelin basic protein (MBP) in the nerves myelin is attacked. Inflammation and ultimate loss of myelin causes disruption to nerve transmission and affects many functions of the body.
An estimated 2,000,000 people in the world have MS, half of which have secondary progressive MS. There have been few treatments for secondary progressive MS approved to date, and many of these treatments face limitations in terms of demonstrating a strong effectiveness and lack of side effects. This potentially represents a very large and unique market opportunity for MBP8298.
About BioMS Medical Corp.
BioMS Medical Corp. is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies. BioMS Medical's patented MBP8298 technology for the treatment of multiple sclerosis has undergone Phase I and II human clinical trials. The Company has recently licensed a second platform technology, HYC750, involving a potential method for mobilization of stem cells and neutrophils for the treatment of cancer therapy related side effects. BioMS Medical trades on the Toronto Stock Exchange under the symbol MS. For further information, please visit our web site at: www.biomsmedical.com.
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.
Copyright © 2003, Canada NewsWire