RegeneRx Biopharmaceuticals has received a notice from the FDA indicating that, due to non-compliance with FDA's current Good Manufacturing Practice (cGMP) regulations by its contract manufacturer, the company's phase II clinical trial of RGN-352, its injectable formulation of Thymosin beta 4 for the treatment of acute myocardial infarction (AMI), has been placed on clinical hold.

The clinical hold is limited to cGMP compliance issues at a specific contract manufacturing site and is not directed at the safety of RGN-352, the company's phase II AMI protocol or its clinical development plan, nor does it affect any other RegeneRx clinical trial or drug candidate.