BioMS Medical initiates follow-on open-label MAESTRO-02 Multiple Sclerosis trial

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BioMS Medical Corp announces 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."

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.

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.