Centocor Inc. said Wednesday its humanized monoclonal antibodyagainst tumor necrosis factor (TNF) reduced the severity ofsymptoms associated with Crohn's disease in more than 65 percent ofthe patients treated with the drug in a Phase II study.

The placebo-controlled trial involved 108 patients who receivedeither a placebo or one of three doses of the antibody, calledCenTNF. The drug is designed to block TNF, a cytokine whoseoverstimulation of the immune system is linked to inflammatorydisorders, such as Crohn's disease, which is inflammation of thegastrointestinal tract.

Centocor, of Malvern, Pa., also is testing CenTNF in clinical trialsfor treatment of rheumatoid arthritis. Results from a recentlycompleted Phase II study will be released later this year.

Symptoms of Crohn's disease, which leads to a thickening of thebowel wall, include diarrhea, fever and pain. The current primarytherapies involve steroids. Patients enrolled in Centocor's Phase IIstudy had received steroids, but were not responding to thetreatments. They continued to take steroids and aspirin during thetrial.

Patients treated with CenTNF received a single infusion of the drugand were monitored for 12 weeks. More than 65 percent of thepatients who received CenTNF experienced improvement after fourweeks as measured by a scale called the Crohn's Disease ActivityIndex (CDAI). By comparison only 17 percent in the placebo groupshowed improvement.

Patients with scores above 150 points on the CDAI scale have activedisease. Those enrolled in the Phase II study registered between 220and 400, a range of moderate to severe disease activity.

Bruce Carroll, Centocor spokesman, said the primary endpoint of thetrial was a reduction of 70 points on the scale after four weeks. Datafrom the study showed a median drop of 107 points among those inthe treatment group. Carroll added a third of the patients whoreceived CenTNF dropped below 150 on the scale, meaning thedisease was in remission.

The investigators said most patients who responded to themonoclonal antibody maintained their level of improvement through12 weeks. CenTNF also was well tolerated.

Carroll said Centocor will meet with the FDA to discuss the findingsand determine how to proceed. The company expects to seek apartner for late-stage trials of CenTNF for rheumatoid arthritis, butmay attempt to continue development on its own for Crohn's disease.

Centocor's stock (NASDAQ:CNTO) closed Wednesday at $38.37,down 25 cents. n

-- Charles Craig

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