RegeneRx AMI Trial Placed on Clinical Hold

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.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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...

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