RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) informed stockholders at its 2001 Annual Meeting that it is concentrating its efforts on the development of Thymosin Beta 4 (Tß4) for the treatment of chronic wounds in several clinical areas including chronic pressure sores, diabetic ulcers, eye injuries, and smaller orphan indications. The company estimates that the total market size for such products is well over $7 billion annually in the U.S. According to the company, there are few products that have made a significant impact on chronic wounds, including much publicized growth factors and synthetic skins, although there are a number of firms working on wound healing products. “Any product that can significantly improve the healing process at a reasonable cost will undoubtedly receive strong market acceptance by patients, physicians and insurance companies,” according to Dr. Allan L. Goldstein, founder and Chairman of RegeneRx.

“We believe Tß4 will have a significant impact on the treatment of chronic wounds and other related indications,” said Dr. Goldstein. “This compound represents a new type of wound healing product that has been shown to positively affect several aspects of the wound healing cascade including regulation of actin, anti- inflammation and angiogenesis. At the NIH, researchers have had excellent (and statistically significant) results in both dermal and corneal wound healing in small animals. Based on the results to date, we very much look forward to initiating human clinical trials as soon as possible.”

Impaired wound healing is a problem for the elderly, diabetics, immobilized individuals, and those with burns and inherited skin diseases. The cost of treating all chronic wounds is estimated at over $7 billion per year in the U.S. and is expected to increase 10% annually. Of the 14 million diabetics in the United States, an estimated 1.5 million suffer from impaired healing. The incidence of pressure ulcers is even greater with 5 million in the acute care setting, 1.2 million in the long-term health care setting, and 1.1 million in the home health setting. At present, the cost of treating a single pressure ulcer can be as high as $50,000, and may require several months or even years to heal.

Tß4 is a 43 amino acid peptide which exhibits a number of physiological properties not seen with other wound healing drugs and growth factors under development. The actions include the ability of Tß4 to sequester and regulate actin – a protein needed to form and maintain the structure of the skin and facilitate its repair – as well as by stimulating the formation of new blood vessels (angiogenesis) and reducing inflammation, all of which play important roles in wound healing and the remodeling process.

RegeneRx Biopharmaceuticals, Inc. is a development stage biopharmaceutical company focusing on products to treat a variety of human diseases. The company hopes to begin Phase I wound healing clinical trials during 2001/2002 and is presently working toward that goal.

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 and commercialization of Tß4 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 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 Annual Report on Form 10-KSB for the year ended December 31, 2000. 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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