BioMS update

A board to discuss future MS therapies in early stage (Phase I or II) trials.

BioMS update

Postby dignan » Mon Nov 12, 2007 10:05 am

Here is a press release from BioMS on enrollment in their US phase 3 trial for people with SPMS:



BioMS Medical achieves enrollment milestone in U.S. phase III multiple sclerosis trial

November 12 - CNW - BioMS Medical today announced that more than 133 patients have been enrolled in its MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). An interim safety and efficacy analysis will be performed on data from the first 133 patients enrolled when they have completed 24 months of the clinical trial.

"There has been overwhelming enthusiasm and support from the MS community for our U.S. Phase III trial," said Kevin Giese, President and CEO of BioMS Medical.

"With the ramp-up in the initiation of participating clinical sites and patient recruitment we are on track to complete enrollment in the first half of 2008."

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical 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), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

MBP8298 is being developed in three late-stage clinical trials:
- MAESTRO-01: A pivotal phase III trial in Canada and Western Europe evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study and is fully recruited with 611 patients.

- MAESTRO-03: A pivotal phase III U.S. trial evaluating MBP8298 for the treatment of SPMS. The trial is a randomized, double-blind study enrolling approximately 510 patients.

- MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of relapsing remitting multiple sclerosis (RRMS). The trial is a randomized, double-blind study and is fully recruited with 218 patients.

http://www.newswire.ca/en/releases/arch ... c6749.html
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