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RegeneRx's Tß4 Reduces Lethality and Decreases Inflammatory Mediators in Endotoxin-Induced Sepsis RegeneRx's Tß4 Reduces Lethality and Decreases Inflammatory Mediators in Endotoxin-Induced Sepsis Tß4 Blood Levels Are Lower in Patients with Septic Shock July 14, 2003 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX - www.regenerx.com) reported today that a paper published in the August, 2003 issue of the scientific journal, International Immunopharmacology (Volume 3, Issue 8, pp. 1225-1233) described how Thymosin Beta 4 (Tß4) reduced the lethality of endotoxin-induced septic shock in animal models. The work was performed at The George Washington University Medical School (GWUMS), Washington, D.C. and the Critical Care Medicine Department, Warren G. Magnuson Clinical Center, The National Institutes of Health, Bethesda, Maryland. Tß4 is being commercially developed by RegeneRx Biopharmaceuticals, Inc. Dr. Allan L. Goldstein, Professor and Chairman of the Department of Biochemistry and Microbiology at GWUMS and Chairman and Chief Scientific Advisor to RegeneRx noted that, "These studies show that Tß4 blood levels are significantly reduced in animals with endotoxin-induced sepsis. The administration of Tß4 within 2-4 hours after the onset of sepsis significantly reduced mortality rates (p<0.024) and lowered blood levels of a number of inflammatory cytokines. Moreover, in human subjects given low doses of endotoxin, and in patients with septic shock, significant decreases in blood levels of Tß4 were noted. The results of this study are very exciting and indicate that Tß4 may have important utility in the treatment of septic shock and in other disorders associated with actin toxicity." Septic shock is often associated with abdominal and pelvic infection resulting from trauma or surgery and with septicemia caused by gram-negative bacteria. Sepsis is the presence of pathogenic organisms or their toxins in the blood or tissues that commonly results in septicemia, which may progress to septic shock. Actin toxicity may result when large amounts of actin are released as cells are damaged during the sepsis cascade, releasing actin into the blood and causing damage to tissues and organs. This damage can become severe, lead to end organ failure and, ultimately, cause death. Tß4 is a naturally occurring 43-amino acid peptide that regulates actin, down-regulates certain inflammatory cytokines, and promotes wound healing. A key mechanism of action is Tß4's ability to regulate actin, the cell-building protein and a vital component of the cytoskeleton. It 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 Biopharmaceuticals, Inc., Bethesda, MD, holds exclusive patents related to the use of TB4 and other acting regulating molecules for treatment of patients with septic shock and indications which may result from actin toxicity. The company began Phase 1 clinical trials in March 2003 specifically to evaluate Tß4 for the treatment of chronic dermal wounds. 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 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 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. |
