RegeneRx Announces Final Clinical Results from Phase | Trial with RGN-352
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 (TÎ²4) 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 TÎ²4’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.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. These product candidates are based on TÎ²4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides. It is currently sponsoring Phase II clinical trials for dermal and ophthalmic wound healing and has now completed a Phase I clinical trial supporting delivery of RGN-352 for acute cardiovascular and other indications requiring its systemic administration. RegeneRx is also developing novel peptides for the cosmeceutical industry based on its experience with TÎ²4 and its biological activities in the skin.
RegeneRx Technology Background
TÎ²4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class, multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, and collagen deposition, while down-regulating inflammation. RegeneRx has identified several molecular variations of TÎ²4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the world, have published numerous scientific articles indicating TÎ²4’s in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to TÎ²4’s mechanisms of action may be viewed at RegeneRx’s web page: www.regenerx.com.
SOURCE: RegeneRx Biopharmaceuticals, Inc.