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BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis

ur late-stage clinical trials:

- MAESTRO-01: A pivotal phase II/III trial for secondary progressive

MS (SPMS) patients in Canada and Europe.

- MAESTRO-02: An open-label safety extension study to MAESTRO-01.

- MAESTRO-03: A pivotal phase III trial for SPMS patients in the United


- MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS)

patients in Europe.

MAESTRO-01 is a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide (MBP8298) in patients with secondary progressive MS. The study is being conducted at 47 sites across Canada and nine countries in Europe and includes 611 patients being administered either dirucotide (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. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

About Dirucotide (MBP8298)


Dirucotide (MBP8298) is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). Dirucotide is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of dirucotide is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients.

The drug's apparent mechanism of action is the induction or restoration of immun

SOURCE BioMS Medical Corp.
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