Marc Feldmann, a professor with London's Kennedy Institute, toldattendees of the 5th Annual Congress on tumor necrosis factor (TNF)and Related Cytokines, that Phase II trials of CenTNF for refractoryrheumatoid arthritis have been completed.While complete details were not released, pending publication,Feldmann said results confirmed those of the open-label study ofMalvern, Pa.-based Centocor Inc.'s drug, which were published inDecember. The just-completed European study involved 73 patients infour centers, with three treatment groups _ placebo, 1 mg/kg and 10mg/kg, followed by a four-week evaluation period.The open-label study, a Phase II trial conducted at the KennedyInstitute, enrolled 20 patients who had failed previous therapies forrheumatoid arthritis. Nineteen patients responded to the 10 mg/kgtreatment of CenTNF, a chimeric monoclonal antibody that binds toTNF."After infusing TNF, the arthritis patients experienced more than a yearof significant relief in the number of swollen joints, and a significantreduction of level-C reactor protein (a measure of arthriticinflammation)," Tim Cost, Centocor's senior vice president of investorrelations and strategic operations, told BioWorld. "The conclusion wasit was safe, well-tolerated and resulted in significant clinicalimprovements . . . that extended six to eight weeks."Centocor, anticipating the Phase II results will confirm the open-labelstudy, expects a multi-dose Phase II trial of CenTNF to be initiatedlater this year in Europe and the U.S., leading to Phase III studiesbeginning early next year, Cost said.CenTNF also is being developed for inflammatory bowel disease,including Crohn's disease and ulcerative colitis, and multiple sclerosis.Five patients in a open-label trial for Crohn's disease "exhibiteddramatic clinical responses to a single 10 mg/kg infusion," Cost said."The response lasted over six weeks and was associated with healing ofmucosal ulcers." A Phase II multi-center randomized trial involving1,200 patients is being initiated in the U.S. and Europe, with the hopeof following that up with a Phase III in early 1995, he said.A 60-patient trial in severe ulcerative colitis is expected to start laterthis year, Cost said.In November, Centocor announced that it signed an agreement with theJapanese company Tanabe Seiyaku Co. Ltd. for the clinicaldevelopment and marketing of CenTNF in Japan. Tanabe will take thedrug through Japanese clinical trials. Cost said Centocor is indiscussions with potential partners for areas other than Japan.
-- Jim Shrine
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