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news.The US Food and Drug Administration (FDA) has issued a notice to RegeneRx Biopharmaceuticals regarding the suspension of its Phase 2 clinical trial of RGN-352 for the treatment of acute myocardial infarction (AMI), due to the non-compliance with FDA's current Good Manufacturing Practice (cGMP) regulations by its contract manufacturer.
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RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications.
RegeneRx said that the suspension of the trial is only limited to the cGMP compliance issues at a specific contract manufacturing site and is not directed at the safety of RGN-352.
Further, the company stated that it has no idea over the timeline of this clinical hold, earlier it was scheduled to start patient recruitment in coming few weeks but with this hold they can not predict the dates.