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RegeneRx's Tß4 Stimulates Critical Wound Healing Protein RegeneRx's Tß4 Stimulates Critical Wound Healing Protein Direct Tß4 - Laminin-5 Connection Discovered February 2, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) reported today that a scientific publication in the most recent issue of the journal, Experimental Cell Research, Sosne et. al., 2004, 293: pp. 175-183, presented new data confirming that Thymosin Beta 4 (Tß4) stimulates epithelial cell migration and promotes laminin-5 (LM-5) expression, each an important component of the wound healing process. "The importance of this study is that it provides the first scientific evidence that Tß4 directly increases LM-5 production in human epithelial cells independent of growth factors such as TGF-?. LM-5 plays a key role in maintaining the structural integrity of the skin and is a vital protein needed for proper healing of wounds. Thus, the observation that Tß4 directly increases the production of LM-5, a protein missing or defective in chronic skin disorders such as Epidermolysis Bullosa, is not only of scientific interest, but also very important to the clinical development of Tß4," said Dr. Allan L. Goldstein, Chairman of Biochemistry and Molecular Biology at The George Washington University Medical Center and Chairman and Chief Scientific Advisor of RegeneRx. Epithelial cells are cells that cover the inner and outer surfaces of the body. The proliferation and migration of epithelial cells are necessary components of the wound healing process. Laminin-5 is one of the initial adhesive proteins expressed after wounding, is necessary for proper adhesion of certain types of mammalian cells, and is an important component of the wound healing process. Patients suffering from certain forms of Epidermolysis Bullosa, a rare inherited skin disease resulting in severe blistering and the inability of the skin to effectively repair itself after injury, among other symptoms, produce abnormally low amounts LM-5. The reported study was conducted by Dr. Gabriel Sosne and his colleagues at Wayne State University School of Medicine and Kresge Eye Institute in Detroit, MI in collaboration with Dr. Hynda Kleinman at the National Institutes of Health in Bethesda, MD. This current publication is one of several key studies by Sosne, et. al. illustrating the properties of Tß4 and showing its potential value in the treatment of ocular and dermal wounds and injuries. Tß4 is a naturally occurring 43-amino acid peptide present 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 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 under an exclusive world-wide license from the NIH. The Company holds several 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. |
