CENTOCOR SCRAPS SECOND PHASE III CENTOXIN TRIAL,

Executive Summary

CENTOCOR SCRAPS SECOND PHASE III CENTOXIN TRIAL, which had been halted in January due to excess deaths in Centoxin-treated patients without gram-negative bacteremia. Centocor is now "evaluating clinical parameters, such as organ failure, and diagnostic tests that measure endotoxemia to better identify... patients [who could benefit from Centoxin] and improve the timing of HA-1A administration," President and CEO David Holveck said March 15. "We believe the trial was flawed in that it failed to identify patients who can benefit from an anti-endotoxin monoclonal antibody like HA-1A," Holveck noted. Centocor plans to meet with FDA and European regulatory officials to discuss issues including a further trial in adults if a test to identify target patients can be found and the feasibility of reinitiating Centoxin sales in Europe. The firm halted European sales of the product in January when the trial was suspended ("The Pink Sheet" Jan. 25, T&G-2). In addition, Centocor has restarted a trial of the drug in patients under 19 years old with fulminant meningococcemia, a gram-negative infection. Centocor had been awaiting an analysis by Bio-Pharm Clinical Services of results from all patients who had enrolled before making a final decision on Centoxin. The final analysis indicated that in patients without gram- negative bacteremia, 14-day mortality was 41% in the Centoxin arm and 38% in the placebo arm, a difference which was not statistically significant. An interim analysis, which did not include patients enrolled close to the suspension date of the trial, also had shown no statistical difference in the mortality rates of the two patient categories, Centocor added.