BioMS Medical completes patient recruitment for multiple sclerosis trial

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BioMS Medical Corp has completed patient recruitment in its phase II clinical trial of MBP8298, for the treatment of relapsing-remitting MS (RRMS). The trial, named MINDSET-01, includes approximately 215 patients, and is being conducted at 24 trial sites in six countries across Europe.

The fifteen-month trial will be followed by a 12-month active treatment open label extension period. The objectives of the study according to president and CEO of BioMS Medical Kevin Giese, is to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

MS is a progressive disease of the central nervous system, characterized initially by episodes of paralysis, blindness, sensory disturbances and cognitive impairment. 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.