Tuesday, December 11, 2007
BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
EDMONTON, Dec. 11 /CNW/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company's on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.
This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
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).
Recently the Company announced that more than 133 patients have been enrolled in its MAESTRO-03 trial. 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.
About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that MBP8298 will continue to demonstrate a satisfactory safety
profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: email@example.com, Internet: www.biomsmedical.com; James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: firstname.lastname@example.org