June 15, 2007
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Enrollment has begun for a study testing the safety and effectiveness of the experimental drug MBP8298 (BioMS Medical Corp.) in 510 people with secondary-progressive multiple sclerosis. Up to 60 sites nationwide will be enrolling patients by September. This drug is administered intravenously (into the vein) every 6 months.People with secondary-progressive MS experience an initial period of relapsing-remitting MS, followed by a steadily worsening disease course with or without occasional flare-ups, minor recoveries (remissions), or plateaus. This phase III study is also known as MAESTRO-03, and the primary investigator is Dr. Clyde Markowitz (University of Pennsylvania, Philadelphia).
Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues.
In that study, the subgroup of patients with HLA types DR2 and/or DR4 experienced a delay in worsening of disease (those on placebo experienced clinical progression of MS at an average of 18 months, while those on active treatment experienced progression at an average of 78 months). Based on these results, BioMS Medical is now conducting several phase II/III studies of MBP8298 in people with MS who are positive for HLA DR2 and/or DR4.
To enroll in this phase III study, people must be 18-65 years of age, with a documented history of secondary-progressive MS. Only people who are positive for the HLA DR2 and/or DR4 genes can participate; a blood test will be taken to determine HLA status. Participants must have had no relapse in the 3 months before the study.
Participants will be randomly assigned to receive either 500 mg of MBP8298 or inactive placebo intravenously every six months for two years. The primary goal of the study is to determine the effectiveness of MBP8298 as measured by the EDSS, a widely used rating system of clinical status. Secondary objectives are to assess the drug’s effects on disease activity observed on MRI (magnetic resonance imaging scans), relapse rates, quality of life and fatigue.
For information on sites that are currently enrolling, please consult the study’s listing on clinicaltrials.gov atwww.clinicaltrials.gov/ct/show/NCT00468611?order=1. Sites will be located in the following states: Arizona Arkansas California Colorado Florida Georgia Illinois Kentucky Maryland Massachusetts New Mexico Michigan Mississippi Missouri Montana New Jersey New York Nevada North Carolina Ohio Oregon Pennsylvania Rhode Island Tennessee Texas Vermont Virginia Washington West Virginia
-- Research and Clinical Programs Department |
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