RegeneRx Enrolls First Subject In RGN-352 Phase IB Clinical Trial, Reducing Cardiac Damage In Patients After An AMI

Main Category: Cardiovascular / Cardiology
Article Date: 23 Sep 2008 - 7:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced today that it has enrolled the first subject in its Phase IB clinical trial in which RGN-352 is being tested in 40 healthy subjects. RGN-352 is an injectable formulation of Tβ4 being developed to reduce cardiac damage in patients after an acute myocardial infarction (AMI or heart attack), as well as for other potential systemic uses. The double-blind, placebo-controlled dose-escalating trial includes four groups of ten subjects each to assess the safety of multiple doses at escalating concentrations of RGN-352 injected into the blood stream. Each person will have a 28-day post-treatment assessment with a 6-month follow-up.

Previously, RegeneRx completed a Phase IA trial in which a single dose of RGN-352, escalating over increasing concentrations, was deemed to be safe and well-tolerated.

"We are pleased to begin the last part of our Phase I program to evaluate RGN-352 administered over a period of 14 days at escalating dose concentrations. We believe that the Phase I trial will provide strong safety and pharmacokinetic data and help us design Phase II trials to evaluate RGN-352 for the treatment of patients after an AMI (acute myocardial infarction), as well as for other potential indications," stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.

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 Tβ4, 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 I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 to reduce cardiac damage in patients after acute myocardial infarction, in addition to other systemic indications.

RegeneRx Technology Background

Tβ4 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 Tβ4 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 Tβ4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to Tβ4's cardio-protective effects have been published in Nature and Circulation. Abstracts of these and other scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page: http://www.regenerx.com.

Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may" or other similar expressions and include statements regarding the safety and efficacy of RGN-137, RGN-259 and RGN-352 and the status and prospects of any ongoing pre-clinical studies and clinical trials, including the Phase I clinical trial related to RGN-352. Actual results may differ materially from those indicated or implied by such forward-looking statements because the Company's product candidates may not demonstrate safety and/or efficacy in current or future clinical trials or as a result of various important factors described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" sections of the annual report on Form 10-K for the year ended December 31, 2007 filed with the SEC on March 28, 2008 and other periodic reports filed with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.