Contact Information: At RegeneRx: At the Financial |
RegeneRx's Tß4 Reported to Inhibit Human Corneal Apoptosis (Cell Death) RegeneRx's Tß4 Reported to Inhibit Human Corneal Apoptosis (Cell Death) Study Identifies Possible Role for Tß4 After LASEK Surgery March 24, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) reported today that a scientific publication in the April issue of the journal, Investigative Ophthalmology and Visual Science, Sosne et. al., 2004 Apr;45(4):1095-100, presented new data indicating that Thymosin Beta 4 (Tß4) prevents apoptosis (cell death) in human corneal epithelial cells exposed to ethanol in vitro. Ethanol is used during LASEK (laser-assisted subepithelial keratectomy) surgery to correct refractive disorders of the eye and has been reported to induce apoptosis. It has been estimated that such disorders affect over 120 million people. Dr. Sosne and his colleagues found that, "Tß4 plays an anti-apoptotic role under conditions of epithelial cell challenge with an external stress such as exposure to ethanol." According to Dr. Sosne, "Alcohol is cytotoxic, so a major concern with the use of ethanol in the cornea is continued viability of the epithelium (outer surface of the cornea) post-procedure as it relates to wound healing and visual rehabilitation. This is especially relevant to LASEK..." "We hypothesize that Tß4 will significantly enhance epithelial cell survival in corneas receiving LASEK by inhibiting the initiation of apoptosis. In this study we provide evidence to support this hypothesis…Because survival of the epithelial cells contained in the flap are critical to uneventful post-operative healing and successful vision correction after LASEK, our results suggest that Tß4 may potentially be useful therapeutically following laser vision correction," according to Dr. Sosne. Dr. Sosne concluded that, "An agent that promotes corneal re-epithelialization, wound healing and cell survival after trauma or surgery without adverse side effects would be a major clinical advance." 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. 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. |
