The patient enrollment in the Phase 3 trial of ReoPro (abciximab) conducted by Centocor Inc. and Eli Lilly and Company 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 abciximab in emergent stroke treatment trial-II (AbESTT-II) recommended that the study not resume enrolment. After reviewing these recommendations, the principal investigators, the AbESTT-II executive committee and both companies have unanimously agreed with the SEMC, and, effective immediately, permanently discontinued enrolment in the trial, claims a company release.
"Patient safety is paramount to all of our drug development programs, so we have taken the prudent step of ending the AbESTT-II trial. While there are no guarantees that every clinical study will succeed, Centocor Inc., and Lilly maintain their R&D commitments to researching and developing safe, effective therapies for patients in need," said Jerome A. Boscia, senior vice president, clinical R&D, Centocor Inc.
The release further states that on October 4, 2005, Centocor Inc. 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. The new recommendation comes after the SEMC reviewed additional efficacy and safety data on most of the 808 enrolled patients to help determine if the benefit-risk profile warranted continuing the study. All outstanding follow- up evaluations and data from patients who have been enrolled will continue to be collected as quickly as possible and general unblinding of the trial will occur once the database is locked, which is expected to occur next year.
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 that are supported by more than 14 randomised clinical trials and a decade of clinical experience. ReoPro is not indicated in patients having an acute ischemic stroke.
Acute stroke occurs when a blood vessel becomes blocked in the brain. This blockage prevents oxygen and nutrients in the blood from getting to part of the brain, resulting in the death of that part of the brain.