Regulators slap clinical hold on RegeneRx heart drug study

RegeneRx has been forced to slam the brakes on a mid-stage study of RGN-352, its injectable formulation of Thymosin beta 4 for acute myocardial infarction. According to the company, regulators said that its contract manufacturer wasn't compliant with good manufacturing standards and slapped a clinical hold on the study.

The developer said it can't estimate just how long the trial will be on hold, and it didn't identify the contract manufacturer it's fingering for the holdup. RegeneRx was scheduled to begin enrolling patients in the trial in the coming weeks.

RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases. In a Phase I clinical trial the drug was found to be safe and well-tolerated.

- here's the RegeneRx release