MILES/CHIRON’s ANTI-TNF MAb SHOWS "TREND" IN MORTALITY REDUCTION
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.
Sign in to continue reading.
New to Pink Sheet?
Start a free trial today!
Register for our free email digests: