Not sure if this was posted yet, minor update (posted over at Accelerated Cure):
BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
BioMS Medical Corp. (CA:MS: news, chart, profile) , a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Drug Safety Monitoring Board (DSMB) for the MAESTRO-01 trial has conducted the scheduled interim analysis of efficacy and safety and has recommended that the trial continue to completion. MAESTRO-01 is the pivotal phase II/III Canadian and European study of dirucotide (MBP8298) in patients with secondary progressive MS.
The interim analysis included patients from the first 200 to complete MAESTRO-01 and assessed the likelihood of the study reaching its primary endpoint at the end of the trial in MS patients with the target HLA-DR2 and/or HLA-DR4 immune response genes. The DSMB analysis also included a scheduled review of safety information.
Based on the DSMB decision, Eli Lilly and Company has agreed to provide the $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement.
"We are very encouraged by the safety board's recommendation," said Kevin Giese, President and CEO of BioMS Medical. "This positive review is an important milestone for BioMS and our partner, Eli Lilly and Company, and moves us one step closer to our goal of bringing this important therapy to multiple sclerosis patients."
"We are pleased by the results of the interim analysis and look forward to final efficacy and safety data from this trial next year," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and Director of the MS Research Clinic at the Ottawa Hospital. "If successful, this novel therapy administered only twice per year, could help a large underserved population with late stage MS."