BioMS Medical cleared by FDA to initiate pivotal phase III multiple sclerosis trial
BioMS Medical Corp announced that it has received clearance from the United States food and Drug Administration (FDA) of its Investigational New Drug Application (IND) for the initiation of a pivotal phase III clinical trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive MS.
The IND allows the commencement of a pivotal phase III secondary progressive MS clinical trial in the US and has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the completed and ongoing clinical studies for MBP8298.
The pivotal phase III clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 510 patients who 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 patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).
In MS patients, the body's immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise "tolerant" of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.
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