AutoImmune Inc. has started a Phase II dosing trial of Colloral, its oraltolerance drug for rheumatoid arthritis, the Lexington, Mass., companyannounced Wednesday. The 280-patient trial is being conducted at sixU.S. centers.In September, AutoImmune reported positive results from a Phase IItrial of the injestable chicken-bone collagen, in which four of 28treated patients were rated as being in complete remission and othershad up to 30 percent reduction in terms of the number of swollen andtender joints."We wanted to do a dose-ranging study to set us up properly for PhaseIII," which the company hopes to start in 1995, Thomas Hennessey,vice president, chief financial officer and treasurer of AutoImmune,told BioWorld. The double-blind trial will test doses of 20, 100, 500and 2,500 micrograms per day, as well as a placebo arm, he said.Endpoints include numbers of swollen joints and the number of tenderor painful joints.The protocol also will includes a "washout" period, during whichpatients will be taken off other drugs to eliminate unrelatedpharmaceutical impact.Colloral, formerly called AI 200, is the second of five drugs based onthe science of oral tolerance, which attempts to reduce autoimmuneattacks by feeding the patient proteins derived from the area underattack.AutoImmune started a 504-patient Phase III study of Myloral formultiple sclerosis in March. AI 300 for uveitis is in Phase II. AI 401,intended to treat Type 1 diabetes, is in a Phase I safety study, and AI502 is in preclinicals for organ transplant rejection. _ Jim Shrine
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