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Old 08-24-2008, 12:28 PM
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lady_express_44 lady_express_44 is offline
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lady_express_44 lady_express_44 is offline
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Join Date: Aug 2006
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Quote:
Originally Posted by SandyC View Post
Any idea when this could actually become available?
Cheryl is probaly more up on clinical trials going on, but this is what I've read (on that first link I provided):

As of Aug 1/08 . . .

"BioMS Medical Corp. announced that it has completed patient recruitment in its phase III clinical trial of MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately 510 patients, and is being conducted at 68 trial sites in the U.S."

(They've been recruiting since June/07, which isn't long...)

"MBP8298 (dirucotide) is currently being developed in three late-stage clinical trials:

1. MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe.

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

3. MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.

About MAESTRO-03

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either MBP8298 (dirucotide) 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)."

Tysabri was fast-tracked before the completion of the Phase III trials, so perhaps this treatment could be available in 1 - 2 yrs.

Cherie
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