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CA2 Trial Shows Efficacy in Crohn's Disease MALVERN, Pa., April 4, 1997 -- Data from a pivotal trial in patients with Crohn's disease showed treatment with the cA2 monoclonal antibody produced a statistically significant positive result in the trial's primary endpoint, closure of at least 50% of open fistulae. Results of the secondary endpoint were highly consistent with the primary analysis and with the results of previous trials in Crohn's disease. This trial studied the clinical benefit of cA2, developed by Centocor, Inc., among 94 patients with Crohn's disease who had enterocutaneous fistulae, a complication of the disease in which extensions occur between the bowel and the skin, allowing drainage of mucous and/or fecal material. According to Dr. Daniel Present, Clinical Professor of Medicine at Mount Sinai Medical Center in New York City, and one of the lead clinical investigators in the trial, cA2 is the first drug ever demonstrated statistically in a controlled trial to close fistulae. "These data demonstrating the significant benefit of cA2 in a particularly difficult subset of Crohn's patients represent an exciting breakthrough in the management of Crohn's disease," he said. "The results confirm findings from earlier studies which show that Crohn's disease can be brought under control and, in some cases, into remission with the use of this drug. This treatment will provide physicians with a much needed therapeutic option for patients with this debilitating, chronic disease and this particular complication." Full results of this study will be released at an appropriate medical forum in 1997. Centocor is a biotechnology company engaged in the development and commercialization of novel therapeutic and diagnostic products and services that solve critical needs in human health care. The Company concentrates on research and development, manufacturing and market development, with a primary technological focus on monoclonal antibodies and DNA-based products. E-mail this page to a friend or colleague! To print, use this version