RegeneRx Biopharmaceuticals, Inc (RGN)

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8:30AM Regenerex Biopharam announces final clinical results from Phase I Trial with RGN-352 (RGN) 0.60 : The co announces that it has completed and analyzed the safety data from its double-blind, placebo controlled Phase I clinical trial evaluating the systemic administration of RGN-352. 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. There were no adverse events judged to be associated with administration of RGN-352, which 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. RGN-352 is an injectable formulation of thymosin beta 4 (Tb4) peptide. RegeneRx will utilize this data to support a Phase II cardiovascular clinical trial in patients immediately after ST-elevation myocardial infarction (acute heart attack), based upon numerous published scientific papers indicating Tb4's ability to improve heart function and reduce myocardial damage in various animal models after an induced ischemic heart attack. Based on these data, it is the company's belief that RGN-352 may offer the same benefit in patients when administered shortly after unblocking the occluded vessel responsible for the infarction.