BioMS Medical’s MBP8298 Shows Five-Year Delay...
BioMS Medical’s MBP8298 Shows Five-Year Delay of Disease Progression in Patients with Multiple Sclerosis – Results to be presented at the American Academy of Neurology April 4, 2006 -
Edmonton, Alberta, March 7, 2006 – BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that its proprietary drug candidate MBP8298 delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. Treatment and follow-up of patients from a phase II clinical study demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75% of MS patients, had a median time to disease progression (worsening) of 78 months compared to 18 months for patients who received placebo.
“These results show an unprecedented 5-year improvement in time to disease progression in the majority of progressive MS patients,” said Kevin Giese, President and CEO of BioMS Medical. “Pending confirmation of these results in our ongoing international pivotal trial in secondary progressive MS, we anticipate that MBP8298 will represent a novel first in class treatment for MS patients.”
The findings are based on a two-year treatment and five-year follow-on study conducted and analyzed by the University of Alberta and BioMS Medical. The primary objective of the trial was to assess the clinical efficacy of 500mg of MBP8298 administrated intravenously every six months, as measured by the Expanded Disability Status Scale (EDSS). Long-term follow-up treatment and assessment of 20 progressive MS patients with the HLA-DR2 or HLA-DR4 immune response genes demonstrated a median time to progression of 78 months (6.5 years) for MBP8298 treated patients compared to 18 months (1.5 years) for patients treated with placebo in the initial study (Kaplan-Meier analysis, p=0.004).
Details of the study and its findings will be presented at the 58th Annual Meeting of the American Academy of Neurology on April 4, 2006 in San Diego, CA.
Phase II/III Pivotal Multiple Sclerosis Trial
BioMS Medical is currently enrolling patients across Canada, the U.K. and Sweden in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 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). To date the trial has successfully completed three safety reviews by its independent Data Safety Monitoring Board.
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