ENROLLMENT IN STROKE TREATMENT TRIAL HALTED AMID SAFETY CONCERNS

Eli Lilly and Centocor have temporarily suspended enrollment in a late-stage clinical trial of their heart treatment ReoPro after a review of preliminary trial data revealed a potential safety problem with the drug.

The Phase III trial, which is examining ReoPro (abciximab) as a potential treatment for acute ischemic stroke, was stopped after the study's independent safety and efficacy monitoring committee (SEMC) observed a safety concern in the trial data. Lilly and Centocor didn't reveal details about the safety concern.

The SEMC is in the process of evaluating the entire risk-benefit profile of ReoPro for acute ischemic stroke patients before coming to a final recommendation on whether or not enrollment in the trial should resume. Patients currently enrolled in the trial will not receive additional doses of ReoPro and data for these patients will be reviewed before the SEMC provides its recommendation on how to proceed with the Abciximab in Emergent Stroke Treatment Trial-II (AbESTT-II).

AbESTT-II is a multinational, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of ReoPro in improving neurological function and minimizing disability in patients who have had an acute ischemic stroke. Preliminary results from other trials suggested the drug might be useful in the treatment of stroke beyond the three-hour time window in which the only currently approved therapy is used to dissolve blood clots in ischemic stroke patients.

ReoPro is already approved 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. Lilly and Centocor said they are not aware of any new data that change the favorable product profile for ReoPro in approved indications.