Centocor Inc. and Eli Lilly and Company, has temporarily suspended the enrollment in the Abciximab in emergent stroke treatment Trial-II (AbESTT-II), the phase III trial of Reopro (abciximab) for the treatment of acute ischemic stroke.

The trial's independent Safety and Efficacy Monitoring Committee (SEMC) observed a safety concern from trial data collected and is in the process of evaluating the entire benefit-risk profile of Reopro for acute ischemic stroke patients before coming to a final recommendation of whether or not enrollment in the trial should resume.

According to a company release, the patients currently enrolled in the trial will not receive additional study drug and data for these patients will be reviewed before the SEMC provides its recommendation on how to proceed with the AbESTT-II trial.

"Safety is our top priority, so we are halting enrollment in order for the SEMC to carefully evaluate the data and determine whether the benefit-risk profile of Reopro for the treatment of acute ischemic stroke warrants reinitiating trial enrollment," said Jerome Boscia, senior vice president, Clinical R&D, Centocor, Inc.

Reopro is currently indicated as an adjunct to percutaneous coronary intervention (PCI) for the prevention of cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24 hours.