RegeneRx Receives IND to Begin Cardiovascular Clinical Program

Phase 1 Trial with Novel Cardio-Protective Drug Candidate Cleared for Initiation by FDA

BETHESDA, MD, USA | May 2, 2007 |
REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) (www.regenerx.com) announced today that it has been cleared by the FDA to begin a double-blind, placebo-controlled phase 1A clinical trial for Thymosin beta 4 (TB4) in forty healthy volunteers using an intravenous (IV) route of administration. The purpose of the phase 1A trial is to determine if a single dose of TB4, administered by the IV route, is safe at various escalating dose levels. Upon an acceptable safety assessment and subsequent FDA clearance, it will be followed by a 1B trial where TB4 will be administered over multiple IV doses at escalating levels in the same subject population.

These phase 1 studies are broadly designed to support planned phase 2 clinical trials where the systemic administration of TB4 is warranted and, in particular, a follow-on phase 2 cardiovascular trial designed to evaluate safety and efficacy of TB4 in patients after an acute myocardial infarction or heart attack. Phase 2 trials will be designed to reproduce the cardio-protective, functional and survival data seen in animal models following administration of TB4 after permanent blockage of a main coronary artery, previously published in two Nature articles and reported in other studies.

"We are very excited that we are able to initiate clinical trials for our cardiovascular program with our TB4 drug candidate. Obviously, acute myocardial infarction and other forms of ischemic heart disease are very important medical indications with high mortality, morbidity and cost and ones in which we hope to have a positive impact with TB4. This effort also allows us to expand our technology platform in other relevant clinical areas benefiting from the systemic delivery of TB4," 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 molecules to accelerate tissue and organ repair. Currently, RegeneRx is developing TB4, a 43 amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that TB4 may prove efficacious for multiple indications; therefore, RegeneRx is developing TB4 as the cornerstone of its therapeutic platform. The technology platform has many potential applications in both the pharmaceutical and consumer products sectors. RegeneRx holds nearly 60 world-wide patents and patent applications related to dermal, ocular, and internal wounds and tissue repair, cardiac and neurological injuries, septic shock and several consumer product areas. RegeneRx is currently sponsoring three Phase 2 chronic dermal wound healing clinical trials and has been cleared by the FDA to initiate ophthalmic and cardiovascular clinical trials as part of its ongoing clinical development program.

The RegeneRx Technology Platform

TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. One of TB4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement. Of the thousands of proteins in cells, actin represents up to 10% of the total protein and, thus, plays a major role in the physiology of the cell. 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 that TB4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. In two articles published in the scientific journal, Nature, researchers found that TB4 protects heart tissue following a myocardial infarction (heart attack) and can regenerate coronary vessels in laboratory animals. Abstracts of scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.

Safe Harbor Statement

The information in this press release may include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements concern the Company's current expectations regarding future events, including the ongoing and prospective development of TB4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of product development and the regulatory approval process, the forward-looking statements are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its most recent Annual Report on Form 10-KSB. The Company assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company.


SOURCE: RegeneRx Biopharmaceuticals, Inc.

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