Genzyme Corporation has ceased to enrol new patients in its phase 2 cardiac cell therapy trial. The trial's Data Monitoring Committee (DMC), following a planned review of preliminary safety and efficacy data, recommended this step after concluding that there is a low likelihood that the trial would result in the hypothesised improvements in heart function, and that the study hypothesis has been adequately tested.
"Based on the preliminary results observed to date, we concur with the DMC that it is unlikely this trial will achieve success. Given this likely outcome, and the risks inherent in any clinical trial, we concluded that the most prudent action is to stop any new enrolment in the trial. We will continue to follow all 95 patients who have been enrolled to date, and will collect all data specified in the protocol throughout the follow-up period," said Richard Moscicki, chief medical officer for Genzyme.
Genzyme and the trial's Steering Committee will conduct a thorough analysis of all efficacy and safety data from the trial at its completion, and will present the results when this analysis is complete, states the company release.
The Myoblast Autologous Graft in Ischemic Cardiomyopathy (MAGIC) trial was designed to test whether autologous skeletal myoblasts can be used to reverse damage done to cardiac muscle following a heart attack, or to safely halt a patient's further progression of heart failure.
Genzyme is one of the leading biotech companies, and focuses on high-priced drugs for diseases with tiny populations.