Contact:

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

RegeneRx Biopharmaceuticals, Inc. (AMEX:RGN) (www.regenerx.com) announced that it has filed an Investigational New Drug Applications (IND) with the U.S. FDA requesting permission to begin a Phase 1A human clinical trial for Thymosin beta 4 (TB4) in healthy volunteers using an intravenous (IV) route of administration that will be tested in patients with ischemic cardiovascular disease in Phase 2. The company may initiate the study 30 days after filing an IND if it does not otherwise hear from the agency.

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. This study will be followed by a 1B trial where TB4 will be administered over multiple doses at escalating levels. The Phase 1 studies are designed to support Phase 2 clinical trials where IV (systemic) administration of TB4 may be warranted and, in particular, a follow-on Phase 2 cardiovascular trial currently being designed to evaluate safety and efficacy of TB4 in patients with ischemic heart injury, such as a heart attack.

The Phase 2 trial will expand upon the cardioprotective, functional and survival data seen in animal models following administration of TB4 after an acute myocardial infarction (heart attack) published in two Nature articles and reported in other non-published studies. The company's cardiovascular clinical program is based upon data first reported by Dr. Deepak Srivastava and his colleagues at the University of Texas Southwestern Medical School in Dallas and, more recently, confirmed and elaborated by Dr. Paul Riley and his colleagues at University College, London Institute of Child Health. Dr. Srivastava is now Director of the Gladstone Cardiovascular Institute in San Francisco and a member of the company's medical and scientific advisory board.

"We look forward to the initiation of the first clinical trials using a systemic administration of our TB4 drug candidate in preparation for treating cardiovascular patients who have a heart attack. Annually in the U.S. over one million people are victims of heart attacks and millions more suffer from chronic heart failure. Ischemic heart disease is the leading cause of death worldwide. Obviously, these are important medical indications and we are, therefore, eager to initiate our cardiovascular clinical program and fully capitalized on the properties of TB4," said 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 additionally targeted ophthalmic and cardiac trials in 2007 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-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.

SOURCE: RegeneRx Biopharmaceuticals, Inc.

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