Print This Page Shepherd Center to Take Part in Only Phase III Trial for Drug that Targets Secondary Progressive Multiple Sclerosis October 24, 2007 Entitled MAESTRO-03, the phase III multi-center clinical trial is a double-blind, placebo-controlled study that will evaluate the efficacy and safety of a proprietary drug called MBP8298, administered intravenously every six months. In a study published in the European Journal of Neurology in August 2006, MBP8298 showed a five-year delay in median time to disease progression in a subgroup of MS patients who have immune response genes HLA-DR2 and/or HLA-DR4. These genes are found in up to75 percent of all MS patients. MBP8298 is a synthetic replica of the molecular site on Myelin Basic Protein (MBP) that is a dominant site of immune attack in MS patients with HLA types DR2 or DR4. Periodic high dose intravenous administration of this synthetic peptide is believed to induce and maintain immune system tolerance to this normal nerve component. It is not expected to affect immune system reactions to substances unrelated to the injected peptide. Currently there is a lack of safe and efficacious drugs that are specifically indicated for the treatment of SPMS and MBP8298 is the only novel agent for SPMS in phase III trials in the world. “While we continue to make incremental progress in providing clinical benefit and therapeutic convenience to patients with relapsing-remitting MS, there remains relatively little we can do to help the many who are trying to retain an acceptable quality of life with the unrelenting, secondary progressive form of this disease,” said Dr. Ben Thrower, MD, Medical Director, Shepherd Center Multiple Sclerosis Institute. “MBP8298 introduces a new approach that we are excited to test based on Phase II study results that show promise in the delay of disease progression. The potential viability of this drug underscores the decision to evaluate it with a large patient population.” The MAESTRO-03 clinical trial anticipates enrolling approximately 510 patients at up to 65 sites 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). MBP8298 has successfully completed phase I and II clinical trials and has more than 450 combined patient years of treatment experience with a favorable safety profile which has been documented over many years. MBP8298 was discovered by two research scientists at the University of Alberta. The drug is exclusively licensed by BioMS Medical Corp., a Canadian-based biotechnology company listed on the Toronto Stock Exchange (TSX: MS). BioMS Medical received clearance from the U.S. Food & Drug Administration (FDA) to initiate MAESTRO-03 in January 2007. An additional Phase III clinical trial for MBP8298 as a potential new treatment for SPMS, MAESTRO-01, is being undertaken in Canada and Europe. MBP8298 is also being evaluated as a potential therapy for relapsing-remitting MS in a Phase II trial in Europe entitled MINDSET-01. Patients and family caregivers interested in learning more about the MAESTRO-03 trial can visit www.clinicaltrials.gov or call Carlyn Kappy at Shepherd Center at 404-367-1365 or email carlyn_kappy@shepherd.org.
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