RegeneRx Biopharmaceuticals, Inc. (Pink Sheets: RGRX), announced today that it has signed an exclusive licensing agreement with the National Institutes of Health (NIH) for Thymosin Beta 4 (Tß4) a compound which has shown exciting potential in the field of wound healing. For the past several years the NIH's Institute of Dental and Craniofacial Research (NIDCR) has been exploring the vital role of Tß4 in the regeneration, remodeling, and healing of wounds in animal models. According to a paper published in The Journal of Investigative Dermatology, entitled "Thymosin Beta 4 Accelerates Wound Healing," the authors conclude that, "These results suggest that Tß4 is a potent wound healing factor with multiple activities that may be useful in the clinic."

According to Dr. Allan L. Goldstein, founder and Chairman of RegeneRx, "We are very pleased to have the opportunity to commercialize Tß4 for tissue repair and wound healing. Tß4 represents a unique class of therapeutics being developed to speed the healing of injured tissues, accelerate the growth of blood vessels and reduce inflammation. We believe it offers a unique approach to quicker and more complete healing in people with chronic pressure sores, as well as other clinical indications."

Under the NIH license, RegeneRx received exclusive world-wide rights to Tß4 with certain milestone payments and royalties due upon commercial sales. In 1998, the NIH filed a world-wide patent application covering this and other areas of interest. The Company hopes to begin Phase I clinical trials during 2001 and is presently working with the NIH toward that goal. The Company and NIH have also met with the U.S. FDA for a pre-IND meeting related to initiation of human clinical trials.

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, (more) 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.

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 NIH 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.

RegeneRx is a development stage biopharmaceutical company focusing on products to treat a variety of human diseases.

The information in this press release includes 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, 1999. 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.

Back To 2001 Press Release Archives