RegeneRx


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NIH Scientists Discover How RegeneRx’s Tß4 Promotes Angiogenesis

NIH Scientists Discover How RegeneRx’s Tß4 Promotes Angiogenesis

Researchers Map Critical Region of Thymosin Beta 4 Molecule

September 25, 2003 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX, www.regenerx.com), announced today published findings that its lead therapy, Thymosin Beta 4 (Tß4), a molecule found in high concentrations in blood platelets, plays a critical role in the wound repair process. The September 2003 issue of the Federation of American Societies for Experimental Biology (FASEB) Journal contains a study detailing how Tß4 promotes angiogenesis from a site within the molecule that binds with actin.

“Angiogenesis plays a critical role in tissue growth and wound repair,” according to Dr. Hynda K. Kleinman, senior author of the paper and chief of the Laboratory of Cell Biology at the National Institute of Health (NIH) Dental and Craniofacial Research, Bethesda, Maryland. “It involves a number of key biological processes, such as cell attachment, basement membrane degradation, cell migration, proliferation, and differentiation – all of which are involved in the wound repair process. This latest discovery gives us a better biological understanding of how Tß4 affects the wound healing process.”

“Dr. Kleinman is considered a foremost authority on wound healing and angiogenesis, and has trained many of the leading scientists in these fields,” explained Dr. Allan L Goldstein, Chairman and Chief Scientific Officer at RegeneRx and Chairman of the Department of Biochemistry and Molecular Biology at the George Washington University Medical School, Washington, D.C.

“Dr. Kleinman, Dr. Deborah Philip - a research fellow in Dr. Kleinman’s laboratory who headed the current research - and their colleagues at the NIH have, through the years, made important contributions to confirming the role of Tß4 in the healing and remodeling of mammalian tissues,” he added. “Their discoveries continue to build a significant body of data on the role of Tß4 in wound healing and tissue repair.”

Tß4 is a naturally occurring 43-amino acid peptide that is vital for the repair and remodeling of injured tissues. Tß4 exhibits potent anti-inflammatory properties, is non-toxic, active systemically and topically, and can be produced synthetically at low cost. Unlike other prospective wound treatments, it is not a growth factor.

Research conducted by the NIH and other academic institutions have found that Tß4 effectively repairs dermal and corneal wounds in numerous animal models under a variety of conditions. Previously, NIH reported that Tß4 was effective in accelerating the healing of wounds in normal, aged, diabetic and steroid-suppressed laboratory animals.

RegeneRx Biopharmaceuticals, Inc. is developing Tß4 for the treatment of acute and chronic wounds and for the treatment of a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the NIH. The Company holds several patents related to the technology and has numerous patent applications pending. The Company has initiated human clinical trials with Tß4 for the treatment of chronic dermal wounds.

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 regulatory approval process and the ongoing and prospective development and commercialization of Tß4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of clinical trials, product development and the regulatory approval process, the forward-looking statements contained in this press release 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.

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