FINAL RESULTS OF 1ST PH III ANTRIL TRIAL

Synergen's recombinant human interleukin-1 receptor antagonist Antril (rhIL-1ra) does not significantly increase survival time in sepsis patients compared to patients receiving placebo, according to the final results of the first Phase III study of the drug, which have been published in this week's Journal of the American Medical Association (June 14). Interim results were circulated last year (Marketletter March 1, 1993).

The multinational Phase III study, authored by Charles Fisher of the department of pulmonary and critical care medicine at the Cleveland Clinic and colleagues, looked at 28-day all-cause mortality in patients with signs and symptoms presumptive of sepsis. The patients received either placebo (n=302), an initial dose of 100mg Antril followed by a 1mg/kg infusion of the drug per hour for 72 hours (n=298), or the same initial dose followed by a 2mg/kg/hour infusion for 72 hours (n=293).

There were 102 deaths among the placebo group (34%), 91 deaths (31%) among the 1mg/kg arm and 86 deaths (29%) among the 2mg/kg arm. There was not a statistically significant increase in survival time for rhIL-1ra treatment compared with placebo among all patients who received the study medication, or among patients with shock at study entry.