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RegeneRx's Tß4 Reported To Accelerate Healing Of Wounds And May Reduce Severity Of Septic Shock RegeneRx's Tß4 Reported To Accelerate Healing Of Wounds And May Reduce Severity Of Septic Shock American Scientist Reports On Research At International Congress Of Immuno-Pharmacology In South Africa September 19, 2001 — Sun City, South Africa It was reported today that Thymosin 4 (Tß4), a molecule originally isolated from the thymus gland, and found in highest concentrations in blood platelets, plays a vital role in the normal healing of wounds and remodeling of damaged tissues. It also now appears Tß4 may be useful for the treatment of septic shock and diseases associated with actin toxicity. Actin toxicity is associated with a variety of clinical situations where cell death, due to infection or trauma, results in the release of large amounts of actin into the bloodstream. These clinical conditions include septic shock, respiratory distress syndrome and certain diseases of pregnancy. In a plenary presentation at the International Congress of Immunopharmacology in Sun City, Pilanesberg, South Africa, Dr. Allan L. Goldstein, Chairman of the Department of Biochemistry and Molecular Biology at the George Washington University Medical School in Washington, D.C., reported that Tß4 significantly reduces the mortality and morbidity of septic shock in rodents following administration of high doses of bacterial endotoxin. Goldstein also reported that in preliminary studies levels of Tß4 were markedly reduced in both the blood of healthy volunteers (following administration of low doses of the same bacterial endotoxin) and in the blood of patients admitted to the emergency room suffering from septic shock. According to Dr. Goldstein, "The results of these studies suggest that the rapid administration of pharmacological doses of Tß4 may be useful in the treatment of septic shock and other clinical indications associated with actin toxicity." From pioneering studies with Tß4 carried out by Drs. Daniel Safer and Vivian Nachmias of the University of Pennsylvania, it is recognized that Tß4 is the major actin-sequestering peptide in mammalian cells. In addition, key experimental studies carried out by Dr. Hynda Kleinman and her colleagues at the National Institutes of Health (NIH) have shown that Tß4 accelerates wound healing and angiogenesis in a wide variety of in vitro and animal studies. Most recently, Dr. Gabriel Sosne et. al. (Exp Eye Res 72:605-608 (2001)) have reported that Tß4 also accelerates the healing and remodeling of corneal injuries, in part, by down-regulating specific inflammatory cytokines. Tß4 represents a new class of wound healing compound. It is neither a growth factor nor a cytokine but, rather, exhibits a number of physiological properties including the ability to sequester and regulate actin, the capability to down-regulate a number of inflammatory cytokines that are present in chronic wounds, and its potent chemotaxis. The regulation of actin (i.e., its polymerization and depolymerization) is a mechanism of action of Tß4 that appears to affect a number of biological processes wherein actin plays a significant role, including septic shock and wound healing. Tß4 is being developed by RegeneRx Biopharmaceuticals, Inc., Bethesda, Maryland (OTCBB: RGRX) under an exclusive world-wide license from the NIH, Bethesda, Maryland. It is anticipated that Phase I clinical trials will begin next year evaluating Tß4 for the treatment of chronic wounds. The information in this press release includes 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. |
