BioMS Medical Initiates Follow-On Open-Label MAESTRO-02 Multiple Sclerosis Trial Of MBP8298
EDMONTON, Alberta, Feb. 27, 2007 - BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), today announced that it has initiated MAESTRO-02, the open-label follow-on portion to its MAESTRO-01 pivotal phase II/III clinical trial of MBP8298 for the treatment of secondary progressive MS.
Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial, may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.
“Now that the first patients who participated in our MAESTRO-01 pivotal trial have completed the study, we are pleased to offer MBP8298 on an open-label basis,” said Kevin Giese, President and CEO of BioMS Medical. “We believe MBP8298 has the potential to become the only safe and effective first line therapy for the treatment of secondary progressive MS. While MAESTRO-01 was designed to evaluate the safety and efficacy of MBP8298, MAESTRO-02 will provide additional important long-term safety and efficacy data to support regulatory submissions.”
About late-stage clinical trials for MBP8298:
BioMS recently announced that patient recruitment has been completed in the MAESTRO-01 trial. This trial includes approximately 550 patients at 48 trial sites in 10 countries. The Company remains on track to receive interim data in mid-2008.
Patients are 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.
MBP8298 is being studied in two additional late-stage clinical trials:
MAESTRO-03: A pivotal phase III U.S. trial of similar design to MAESTRO-01, evaluating MBP8298 for the treatment of secondary progressive MS. The trial is a randomized, double-blind study enrolling approximately 510 patients that will be initiated in 2007.
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 enrolling up to 215 patients
About MBP8298 - Novel Mechanism of Action
In MS patients, the body’s immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of “tolerance” to a critical portion of the nerve’s Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
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 it has two pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally has a Phase II MINDSET-01 trial in Europe for RRMS patients. For further information please visit our website at www.biomsmedical.com .