Friday April 4 10:59 AM EDT
Centocor Announces Positive Results of Pivotal Trial For Crohn's Disease
Product
MALVERN, Pa., April 4 /PRNewswire/ -- Centocor Inc today announced that 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 among
94 patients suffering from 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.
"We are extremely pleased with the results of this pivotal trial for cA2 in the treatment of fistulizing Crohn's disease," said
Joseph C. Scodari, President of the Pharmaceutical Division. "These data demonstrated that cA2 has utility in treating a severe
complication in Crohn's disease patients, and we now look forward to working with the FDA and European health authorities
in bringing this product to the market as quickly as possible." He noted that the data would add a third critical area --
inflammatory disease -- to Centocor's pipeline of therapeutic products in cardiovascular diseases and cancer.
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.
------------
For clarification, can anyone confirm if cA2 and CenTNF are exactly the same drug? |
