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RegeneRx's Drug Subject of First Issued Patent for Wound Healing RegeneRx's Drug Subject of First Issued Patent for Wound Healing March 18, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) reported today that the first patent related to Thymosin beta 4 (Tß4) wound healing technology licensed from the National Institutes of Health in Bethesda, Maryland, has been issued by Australia. The patent, filed in 1999, claims numerous compositions, uses and processes related to the Company's intellectual property. Similar patent applications have been submitted throughout the world, along with over a dozen patent applications regarding diverse properties, uses and compositions related to RegeneRx's technology that go far beyond wound healing. According to J.J. Finkelstein, RegeneRx's President and CEO, "Since initiating development of Tß4 in the late 1990's, it has been our goal to invest heavily in expanding and protecting our intellectual property portfolio. The possibility that Tß4 has many applications as a therapeutic and diagnostic agent requires construction of a comprehensive I.P. portfolio to allow full development of these possibilities. We expect and believe that this Australian patent is only the first of a series of patents to be issued over the coming months and years." Tß4 is a 43-amino acid peptide that occurs naturally in virtually all human cells. It represents a new class of wound healing drug and is different from other wound repair factors, such as growth factors, in that it promotes endothelial cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and has a very low molecular weight, allowing it to diffuse relatively long distances through tissues. A key mechanism of action is Tß4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. Additionally, it has recently been reported that Tß4 directly influences the production of laminin-5, a protein necessary for proper adhesion of certain types of mammalian cells and an important component of the wound healing process. Tß4 has been the subject of a significant amount of research at the NIH and a number of other academic institutions, and has been reported to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of conditions. RegeneRx is a biopharmaceutical company developing Tß4, under an exclusive worldwide license from the NIH, as a platform technology for the treatment of acute and chronic wounds and for the treatment of a variety of human diseases involving tissue and organ repair. The Company holds several earlier patents related to the technology and has numerous world-wide patent applications pending. RegeneRx successfully completed Phase I human clinical trials with Tß4 for the treatment of chronic dermal wounds and expects Phase II trials to begin in the second quarter of 2004. 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 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 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. |
