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Tß4 Significantly Reduced In Old Animals After Corneal Injury Tß4 Significantly Reduced In Old Animals After Corneal Injury New Relationship between Aging and Slower Wound-Healing Identified April 26, 2004 — Bethesda, Md It was reported today at the Association of Research in Vision and Ophthalmology (ARVO) annual meeting in Ft. Lauderdale, Florida that the expression of Tß4 after corneal (outer segment of the eye) wounding was "markedly blunted" in aged animals compared to younger animals. Tß4 is a naturally occurring molecule being developed for dermal, ocular and other wound-healing indications by RegeneRx Biopharmaceuticals, Inc., Bethesda, Maryland, (OTCBB:RGRX) (www.regenerx.com). Dr. Gabriel Sosne and his colleagues at Wayne State University and Kresge Eye Institute in Detroit, Michigan, found that Tß4 levels in young corneas were 2.5 times higher immediately after wounding (peaking at 3 times higher 24 hours after wounding) than in the aged corneas. According to Dr. Sosne, the lead investigator in the study, "This is the first study to demonstrate the presence of Tß4 in corneas after wounding. In this model, young and aged corneas differ in the rates of healing. Since Tß4 is known to promote corneal wound healing, our findings herein suggest a possible relationship between corneal Tß4 levels and rates of re-epithelialization [repair of the outer surface of the eye]." Dr. Allan Goldstein, Chairman of Biochemistry and Molecular Biology at the George Washington University School of Medicine in Washington, DC and Chief Scientific Advisor to RegeneRx stated, "From another perspective, it seems this observation would support the theory that as we age our bodies respond less vigorously than when younger. Not only is Dr. Sosne's finding of a relationship between levels of Tß4 and rates of healing in the cornea among young and aged animals important, but also it is consistent with other studies related to dermal wound healing." 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 numerwous 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. |