RegeneRx Biopharmaceuticals, Inc. has received a notice from the FDA indicating that, due to non-compliance with cGMP regulations by its contract manufacturer, the company’s Phase II trial of RGN-352 has been placed on clinical hold. RGN-352 is an injectable formulation of Thymosin beta 4 in development for the treatment of acute myocardial infarction (AMI). The company was scheduled to begin enrolling patients in the trial in the coming weeks and it is unknown how long the clinical hold will be in place.
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 or the Phase II development protocol. According to the company’s financial filings, it employs a single contract manufacturer for the drug product. As of March 31, 2010, the company was “in the early stages of qualifying backup manufacturers.”