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BioMS gets FDA approval to start Phase 3 MS trial

Jan 19, 2007 - Reuters - BioMS Medical Corp. said on Friday it has received U.S. Food and Drug Administration approval to begin a Phase 3 trial of its multiple sclerosis treatment.

The two-year trial will involve about 500 patients in 50 centers across the United States, chief executive Kevin Giese told Reuters.

Giese said the trial of its treatment for secondary progressive MS is expected to be completed by the end of 2009, with market approval expected about a year later.

"This is big for us. This makes it one of the two pivotal trials we have ongoing in secondary progressive," Giese said.

The U.S. trial complements a trial the company is conducting in Canada and Europe, which is nearing completion of enrollment.

"We have never been in the United States with an open IND (investigational new drug application) before, so getting approval for the Phase 3, and coming with data from outside of the United States is quite an accomplishment," Giese said.

"I think it is really very supportive of the good clinical data that we have had to date."

reference

Do you know which treatment this is?

gwa

Thought I'd just add this update to the existing thread. Last I remember reading, BioMS was hoping to complete enrollment by the end of 2006, so this isn't bad. That means the trial will wrap up in January 2009, so maybe, if it's successful, it could be approved (in Canada and Europe) by the end of 2009.



BioMS Medical completes patient recruitment in MAESTRO-01 pivotal phase II/III multiple sclerosis trial of MBP8298

January 22, 2007 - CNW - BioMS Medical today announced that it has completed patient recruitment in its pivotal phase II/III clinical trial of MBP8298 for the treatment of secondary progressive MS. The trial, named MAESTRO-01, will include approximately 550 patients at 48 trial sites in 10 countries. The Company remains on track to receive interim data in mid-2008 from the first 200 patients enrolled, when they have completed the 24 months of treatment.

"We are pleased to have reached this major milestone in this very important study," said Kevin Giese, President and CEO of BioMS Medical. "It brings us one step closer to our objective of offering patients a safe and effective first line therapy for the treatment of secondary progressive multiple sclerosis, with the convenience of two I.V. doses per year."

"The clinical investigators, study site personnel and BioMS Medical's drug development team all have done an outstanding job of recruiting patients and conducting this trial at the highest quality standards," said Dr. Kjell Stenberg, Chief Operating Officer of BioMS Medical. "The need and enthusiasm for this project in the MS community is well recognized and the results of this pivotal study are eagerly awaited."

MAESTRO-01 Trial
The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The study is being conducted at 48 sites across Canada and Europe and will include approximately 550 patients being 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. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

http://biz.yahoo.com/cnw/070122/bioms_m ... .html?.v=1