IDEC Pharmaceuticals Corp. said Wednesday it has begun enrollmentfor a Phase I/II clinical trial of its "primatized" antibody that will studymultiple doses of the anti-CD4 monoclonal on rheumatoid arthritispatients.The antibody, IDEC-CE9.1, derived from human and monkey antibodycomponents, is being developed with SmithKline Beecham (SKB),which will invest up to $50 million over the life of the collaboration.IDEC is nearing completion of its intravenous single-dose Phase I trialwith the antibody involving 24 patients. It was shown to be safe andwell tolerated at eight dose levels up to 4 milligrams per kilogram ofbody weight."We know enough from the Phase I study to feel confident going on tothe multiple-dose study," David Ludvigson, senior vice president andchief financial officer of IDEC, told BioWorld. "We know the productwas well tolerated and we have seen no evidence of immune systemrejection."End points for the new study, involving up to 45 patients, includesafety and tolerance, rate of antibody clearance from the blood,immune response and clinical activity.To date, Ludvigson said, IDEC has received $9 million from SKB, andthe start of this trial is not a significant financial milestone under theagreement. IDEC, of San Diego, also is being reimbursed for mostdevelopment expenses, he said. SKB, of Philadelphia, has sole rights tothe product in Europe and Asia, while the two companies will co-promote it in North America.Ludvigson said the antibody likely will be tested against otherautoimmune diseases in the future. "The strategy today is to understandthe safety and toxicity profile of the antibody, then determine whichother indications are appropriate."Rheumatoid arthritis was chosen as the first indication, in part, becauseof the large market (2.5 million with the affliction in the U.S.) and lackof an effective treatment. IDEC's research indicating CD4 wasimportant in triggering the disease, and because of the ample numberof patients, making effective trials easier.
-- Jim Shrine
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