RegeneRx


Contact:

RegeneRx:
J.J. Finkelstein
jjfnk@regenerx.com
301.280.1992

RegeneRx, State of Maryland, and University of Maryland, Baltimore Partner to Develop Novel Treatment for Cardiac Reperfusion Injury

RegeneRx, State of Maryland, and University of Maryland, Baltimore Partner to Develop Novel Treatment for Cardiac Reperfusion Injury

September 18, 2007 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (AMEX: RGN) (www.regenerx.com) announced today that it is partnering with the University of Maryland, Baltimore (UMB) and the State of Maryland, through the Maryland Industrial Partnerships (MIPS) program, to develop a novel pharmaceutical product specifically aimed at preventing reperfusion injury associated with cardiac ischemia (heart attack). The State of Maryland is contributing $100,000 of the $232,000 per year to the project at UMB, with an agreement to provide second year funding upon successful completion of the first year’s goals. RegeneRx is contributing approximately $54,000 and retains the right to exclusively license all intellectual property developed under the project.

Reperfusion injury is an event associated with unblocking an artery causing heart attack or stroke. The artery may be opened via clot-busting drugs or angioplasty, a process to mechanically unblock the artery. Reperfusion injury is not completely understood, however it is thought that the unblocking of an artery, which allows blood to again circulate through the damaged vessel and to the site of damage, creates a cascade of events that can further injure already damaged or “at risk” tissue. Therefore, new drugs to eliminate or reduce this potential damage are of high priority.

On September 13, 2007, The New England Journal of Medicine published a review article entitled, “Myocardial Reperfusion Injury.” The authors noted the potential severity of reperfusion injury and its adverse affect on clinical outcome after heart attack, including patient mortality. They noted that new developments in identifying the pathways that can target the known mediators of lethal reperfusion injury, and the ability to influence those pathways, have generated renewed interest in the reperfusion phase as a target for new pharmaceutical therapies. The RegeneRx/University of Maryland project is specifically aimed at that goal.

“We are very excited about this project. It complements our TB4 cardiovascular efforts and may eventually offer a second, synergistic cardiovascular drug candidate that works at a different point in the treatment of patients following a heart attack. We look forward to the results of the work at the UMB over the coming twenty-four months and are please we can leverage our own research funds with those from the State of Maryland through their MIPS program,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer.

“This project serves the MIPS mission, which is to utilize the resources of Maryland’s universities to address significant research problems,” says Martha Connolly, director of MIPS. “We are delighted that RegeneRx and UMB are working together to develop a potentially life-saving product.”

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, ophthalmic, 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, a Phase 2 ophthalmic trial, and a Phase 1A cardiovascular clinical trial 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 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.

About MIPS (www.mips.umd.edu)
The MTECH Maryland Industrial Partnerships Program, an initiative of the A. James Clark School of Engineering’s Maryland Technology Enterprise Institute, brings university innovation to the commercial sector by supporting university-based research projects to help Maryland companies develop technology-based products.

Safe Harbor Statement
The information in this press release may include certain forward-looking statements, including without limitation statements such as “believe,” “estimate,” “expect,” and “target,” 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-K. 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.

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