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MILES/CHIRON’s ANTI-TNF MAb SHOWS "TREND" IN MORTALITY REDUCTION

Executive Summary

MILES/CHIRON's ANTI-TNF MAb SHOWS "TREND" IN MORTALITY REDUCTION among septic shock patients, according to results of a Phase III trial presented Oct. 19 at the Interscience Conference on Antimicrobial Agents and Chemotherapy in New Orleans. The 1,000-patient trial was presented during a poster session by Richard Wenzel, NM, University of Iowa. While the anti-tumor necrosis factor monoclonal antibody, which is licensed by Miles from Chiron, showed no benefit over placebo in reducing mortality among all sepsis patients, Wenzel reported that there was a nonstatistically significant 17% reduction in 28-day mortality among patients with sepsis who were also in shock. In the trial, sepsis patients were treated with a single IV infusion of either 15 mg/kg anti-TNF, 7.5 mg/kg anti-TNF or placebo. Patients were prospectively stratified into shock and non-shock groups. After the first 800 patients were enrolled, an interim analysis was conducted and it was determined that non- shock patients did not appear to be responding to anti-TNF therapy and enrollement of non-shock patients was discontinued. Mortality rates at 28 days post treatment for all sepsis patients in the trial were between 29.5%- 31.3% for those recieving anti-TNF compared to 33.1% for patients receiving placebo. Among shock patients, 28-day mortality was 37.7- 37.8% in the anti-TNF treated patients compared to 45% for patients receiving placebo. Because the number of septic shock patients in the trial was not sufficient to show a statistical difference, Miles is conducting a second Phase III trial only in shock patients. The double-blind randomized placebo-controlled trial, which is expected to begin in January or February, will enroll 600 to 900 patients with septic shock. Patients in that trial will receive either 7.5 mg/kg anti-TNF or placebo. Results from the trial reported at ICAAC are expected to be published in the New England Journal of Medicine in January.
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