Centocor, Inc., a biotech subsidiary of Johnson and Johnson, and Eli Lilly and Company announced Tuesday that they are halting their latest clinical trial for Reopro.
Reopro was first approved by the Food and Drug Administration in 1994, and is currently used to help prevent blood clots. The latest clinical trial was testing the use of Reopro in the treatment of 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. Approximately 85% of all strokes are termed ischemic, meaning they are caused by a blood clot or plaque that blocks a blood vessel in the brain.
The trial’s independent safety committee observed a safety concern from trial data
The trial’s independent safety committee observed a safety concern from trial data collected thus far and is in the process of evaluating the entire benefit-risk profile of Reopro for acute ischemic stroke. The committee is expected to make a final recommendation of whether or not enrollment for the trial should resume.
“Safety is our top priority, so we are halting enrollment in order for the SEMC (safety committee) to carefully evaluate the data,” said Jerome A. Boscia, M.D., senior vice president, R&D, Centocor, Inc.
Patients currently enrolled in the study will not receive any additional Reopro. Approximately 150 clinical sites were participating in the trial, which began in 2003. The goal for enrollment was 1,800 participants.
Although no information was released describing the safety concern, Reopro is known to increase the risk of bleeding, especially when used with blood thinners.
The companies stated that there is no new data suggesting safety concerns with Reopro in existing FDA-approved indications.