REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today
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 (Tβ4)
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 Tβ4’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.
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