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First Injectable use of RGN-352 Tested in Humans
BETHESDA, MD, USA | July 03, 2008 | REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) (www.regenerx.com) announced today that it has completed enrollment and dosing of 40 healthy subjects for its Phase IA clinical trial testing RGN-352, an injectable formulation of TB4 for potential use in treating acute myocardial infarction patients (AMI or heart attack). The trial includes four groups of ten subjects each to assess the safety of escalating doses of RGN-352 injected into the blood stream. To date, there have been no significant drug-related adverse events. A final analysis and report will be completed after 28 days of follow-up of the last subject.
RegeneRx expects to initiate the second part of Phase I with a Phase IB trial in the 3rd quarter 2008 after submitting a IA report to the FDA. The IB trial design is similar to IA; however, the 40 subjects will be dosed once daily for 14 days, rather than given only a single dose, and will undergo a 28-day and a 6-month follow-up.
"We have reached an important milestone with the completion of enrollment and dosing of the Phase IA trial. RGN-352 appears to be safe in single doses at low, medium, and high concentrations. This is an exciting and positive step as we prepare for the IB phase of the trial. This trial is intended to provide the safety data for Phase II clinical trials that are being planned to evaluate RGN-352 for the treatment of patients immediately after an AMI and also to support other potential uses of RGN-352 in medical indications where short-term systemic administration of the drug candidate may be warranted," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.
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 TB4, 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 and is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase IA parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.
RegeneRx Technology Background
TB4 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, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of TB4 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 U.S., have published numerous scientific articles indicating TB4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to TB4's cardio-protective effects have been published in Nature and Circulation. Abstracts of these and other scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
SOURCE: RegeneRx Biopharmaceuticals, Inc. |
