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Executive Summary

TRITON BIOSCIENCES BETASERON PHASE III STUDY FOR MULTIPLE SCLEROSIS is targeting a total enrollment of 30 remitting-relapsing multiple sclerosis (MS) patients at 10 centers in the U.S. and Canada. The company, which began treating patients with early stage MS in July, expects the study to last two years, with a Product License Application filing for early 1991. The remitting-relapsing phase of MS occurs during the first 10 years following diagnosis of the disease. The second and final stage of MS is the chronic progressive phase. With Betaseron, Triton will attempt with its beta interferon product to lessen the frequency of "exacerbations" in subjects, and attempt to slow the progression of the disease. Other measures of efficacy will include changes in the duration, severity or consequences of exacerbations that do occur. The MS patient population is estimated at 250,000 in the U.S. and 50,000 in Canada. The randomized, double-blind study will have three treatment groups: one-third will receive placebo, with the remaining patients receiving Beta-seron 9 mil. or 45 mil. units. Patients will self-administer the treatment via subcutaneous injection every other day for two years. Betaseron (beta interferon) was originally developed by Triton parent Shell Oil and Cetus as an anticancer agent. In a consolidation of its biotechnology research activities, Shell formed Triton in 1983 to test the product's therapeutic possibilities and conduct clinical studies. Betaseron "has the ability to modulate the body's immune response in a manner which may be or benefit to patients with MS, a disease which has many damaging autoimmune components," the company said. Triton is also studying Betaseron in AIDS. The firm announced in June that it would be advancing AIDS trials to Phase III in 300 patients treated in 15 centers nationwide ("The Pink Sheet" June 20, T&G-3). Betaseron is being studied in combination with reduced doses of AZT. Triton's pharmaceutical development program also includes another potential AIDS drug, CS-87, which is reported to be nearing the clinical testing phase.

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