RegeneRx Completes Phase I Trial For RGN-352

Regenerx Biopharmaceuticals (Regenerx) has completed and analysed the safety data from its double-blind, placebo controlled Phase I clinical trial evaluating the systemic administration of RGN-352. RGN-352 is an injectable formulation of thymosin beta 4 (Tß4) peptide.

Reportedly, the trial included testing of a single escalating intravenous dose of the drug candidate on forty healthy volunteers in Phase IA and, subsequently, over a fourteen-day treatment period on forty volunteers in Phase IB.

The company said that RGN-352 was deemed to be well-tolerated. The results of the trial will be published in the Annals of the New York Academy of Sciences, and a clinical study report will be forwarded to the FDA.

RegeneRx will utilise the data to support a Phase II cardiovascular clinical trial in patients immediately after ST-elevation myocardial infarction, based upon numerous published scientific papers indicating Tß4’s ability to improve heart function and reduce myocardial damage in various animal models after an induced ischemic heart attack.

Based on these data, the company feels that RGN-352 may offer the same benefit in patients when administered shortly after unblocking the occluded vessel responsible for the infarction.