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news.BioMS Medical has announced that the independent drug safety monitoring board 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 in patients with secondary progressive multiple sclerosis.
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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 multiple sclerosis patients with the target HLA-DR2 and/or HLA-DR4 immune response genes. The drug safety monitoring board (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.
Kevin Giese, president and CEO of BioMS Medical, said: “We are very encouraged by the safety board’s recommendation. 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.”