INTERSEPT Supports BAYX-1351 Efficacy

The results of the INTERSEPT study, presented at the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy, have suggested that Bayer/Chiron's antitumor necrosis factor monoclonal antibody BAYX-1351 has some efficacy in the treatment of patients with septic shock.

INTERSEPT was carried out at 14 centers in 14 countries worldwide and involved a total of 564 patients, according to Jonathan Cohen of Hammersmith Hospital in the UK, who presented the results. 420 patients were in shock at enrollment, said Dr Cohen. Two doses of BAYX-1351 were tested in the study, 3mg/kg and 15mg/kg, but while the lower dose was able to reduce mortality by almost 15%, the higher dose had no effect on survival.

Mortality from all causes at 28 days was 36.7% in the low-dose group and 42.9% in the placebo arm, a 14.5% reduction which was not statistically significant. Mortality in the high-dose group was actually higher than in the low-dose and placebo groups (44.6%). It was suggested at the meeting that, hypothetically, this may occur because high doses of TNF actually reduce TNF activity to such an extent that for some reason the ability of the body to combat the infection is impaired.