RegeneRx Biopharmaceuticals, Inc. announced that it has received a notice from the US Food and Drug Administration (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.
RegeneRx is currently unable to estimate the length of time that the trial will be on clinical hold. The company was scheduled to begin enrolling patients in the trial in the coming weeks. The company will provide additional information as it becomes available.
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.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration and currently has three drug candidates in clinical development and has an extensive worldwide patent portfolio covering its products.
RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. The company has initiated a phase II clinical trial at approximately 20 clinical sites in the US, Israel, and Russia, although this trial is currently on an FDA-imposed clinical hold.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on recent human clinical data, RegeneRx is currently supporting a physician-sponsored phase II dry eye study with RGN-259.
RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a phase II clinical trial for the treatment of the orphan skin disease epidermolysis bullosa.