RegeneRx


RegeneRx Enters Into Research & Development Agreement with National Institutes of Health

RegeneRx Enters Into Research & Development Agreement with National Institutes of Health

May 22, 2001 — Bethesda, Md

RegeneRx Biopharmaceuticals, Inc. (OTCBB: RGRX), announced today that it has entered into a Materials Cooperative Research & Development Agreement (Materials-CRADA) with the National Institutes of Health (NIH) in Bethesda, Maryland. The Materials-CRADA is a continuation of a collaboration between the company and the NIH’s National Institute of Dental and Craniofacial Research (NIDCR) related to Thymosin Beta 4 (Tß4), a compound which has shown exciting results in the field of wound healing. In February, 2001, RegeneRx secured an exclusive world-wide license from NIH for Tß4.

Under the new Materials-CRADA, the Company will provide significant quantities of Tß4 to NIDCR for continued research and development. In return, the Company retains the right to secure an exclusive license related to any patents filed by NIH on new discoveries related Tß4. According to Dr. Allan L. Goldstein, founder and Chairman of RegeneRx, “I am very pleased to continue what has been a very productive collaboration with Dr. Kleinman and her colleagues at NIDCR. As we progress with development of Tß4, the complementary work being performed at NIDCR will allow us to further define and, perhaps, expand the uses of our product.”

Tß4 is a synthetic version of a natural peptide found in highest concentrations in blood platelets, the first cells to enter wounds after tissue injury. Studies at the NIDCR have shown that Tß4 stimulates angiogenesis (formation of new blood vessels) and is effective in rapidly healing injured tissues in rodents and other mammals. Tß4 has a number of important properties that distinguish it from other wound healing drugs on the market or under development in this area. Unlike growth factors and cytokines, Tß4 regulates the actin molecule in most mammalian cells. Actin comprises up to 10% of the protein of non-muscle cells and, as such, plays a central role in cell structure and in the healing of injured or damaged tissue.

Impaired wound healing is a problem for the elderly, diabetics, and immobilized individuals. The cost of treating all chronic wounds is estimated at $5 to $7 billion per year and is expected to increase 10% annually. It is estimated that of the 14 million diabetics in the United States, some 1.5 million suffer from impaired healing problems. The incidence of pressure ulcers is even greater with 4.9 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 pressure ulcer can be as high as $50,000 and require several months or even years to heal.

RegeneRx is a development stage biopharmaceutical company focusing on products to treat a variety of human diseases. The Company is completing pre-clinical work related to Tß4 prior to filing an IND scheduled for later this year or early 2002.

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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