BIOMS MEDICAL TO BEGIN STUDY OF DRUG FOR PROGRESSIVE MS

BioMS Medical has received clearance from the FDA for its investigational new drug application to begin a pivotal Phase III trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive multiple sclerosis (MS).

The Phase III U.S. trial, called MAESTRO-03, a double-blind, placebo-controlled, multicenter study, will be evaluating MBP8298 for the treatment of secondary progressive MS. The trial will enroll approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary 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 in patients with HLA-DR2 and/or HLA-DR4 immune response genes.

In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column. The proposed mechanism of action of MBP8298 is to reintroduce a state of tolerance to a critical portion of the nerve's myelin basic protein.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology, showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.