Patient enrollment in the phase 3 trial of ReoPro ( Abciximab ) for the treatment of acute ischemic stroke has been permanently discontinued.

Based on careful review of the data and the observed benefit-risk profile, the trial's independent Safety and Efficacy Monitoring Committee ( SEMC ) for the Abciximab in Emergent Stroke Treatment Trial-II ( AbESTT-II ) recommended that the study not resume enrollment.

After reviewing these recommendations, the principal investigators, the AbESTT-II Executive Committee and Companies, Centocor and Lilly, have unanimously agreed with the SEMC, and, effective immediately, permanently discontinued enrollment in the trial.

On October 4, 2005, Centocor and Lilly announced that enrollment in AbESTT-II had been temporarily suspended following a recommendation from the SEMC based on an observed safety concern in the data that it had reviewed.

ReoPro is approved in the United States and many other countries around the world 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. The companies clearly reiterated that they are not aware of any new data that change the favorable product profile of ReoPro in approved indications - indications that are supported by more than 14 randomized clinical trials and a decade of clinical experience.

ReoPro is not indicated in patients having an acute ischemic stroke.

AbESTT-II was a Phase 3, 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 that ReoPro might have been 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.

Most stroke patients do not arrive in the emergency department within three hours of symptom onset.

The trial evaluated two populations: patients randomized within 4.5 hours with planned treatment within five hours of stroke onset ( primary analysis population, n=1200 ) and a companion population of patients randomized 4.5-5.5 hours after stroke onset with planned treatment within six hours or who awaken with stroke symptoms and can be randomized within 2.5 hours of awakening ( n=600 ).

In May 2005, treatment of the small segment of patients awakening after having suffered a stroke was stopped because of an increased risk of intracranial hemorrhage in that population.
At that time, the SEMC recommended continuing enrollment with the remaining groups being evaluated in the trial.

Approximately 150 clinical trial sites participated in the AbESTT-II worldwide trial, which began in 2003. The goal for enrollment was 1,800 participants.

Source: Centocor, 2005


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