Schering AG, Germany announced that it has stopped enrollment in its Phase IIB/III clinical studies for Ad5FGF-4, its investigational, non-surgical angiogenic gene therapy product being developed for the treatment of patients with stable exertional angina due to coronary artery disease.
The company's analysis of the interim data of one of the studies has led it to conclude that the studies, as currently designed, will not provide sufficient evidence of efficacy to warrant continued enrollment. The company is instructing investigators to stop patient enrollment. All patients who have already been treated will continue to be evaluated.
Each study is being monitored by an independent Data Safety Monitoring Board (DSMB). No evidence of important safety concerns was found.