BioMS Medical announces lead investigator in phase III multiple sclerosis trial

Apr 24 2007

BioMS Medical Corp has announced Dr. Clyde E. Markowitz as the lead investigator in the United States for the Company's pivotal phase III clinical trial of its lead drug, MBP8298, for the treatment of secondary progressive multiple sclerosis.

Dr. Markowitz is Director of the Multiple Sclerosis Center at the Hospital of the University of Pennsylvania in Philadelphia. He is an Assistant Professor of Neurology at the University of Pennsylvania School of Medicine and an attending neurologist at the Hospital of the University of Pennsylvania.

"With few approved therapies for secondary progressive MS, this trial is important for the MS community and patients," said Dr. Markowitz. "I am pleased to play a key role in assessing the impact that MBP8298 may have on delaying disease progression of secondary progressive MS."

Dr. Markowitz is a member of the American Academy of Neurology and the International MS Forum. Dr. Markowitz is also Chairman of the clinical advisory committee for the Delaware Valley chapter of the National Multiple Sclerosis Society and a member of the Penn Neuro Care, MS section of the National Multiple Sclerosis Society. Dr. Markowitz is the author and co-author of a number of publications in the field of MS, and he serves as an ad hoc reviewer for Multiple Sclerosis, Journal of Clinical Immunology, Neuro-Rehabilitation and Neural Repair, and The Consultant.

BioMS Medical recently received clearance from the United States Food and Drug Administration (FDA) 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 pivotal phase III clinical trial in the US, named MAESTRO-03, will be 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).