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Scientists Show Tß4 Can be Chemically Integrated Into Fibrin Scientists Show Tß4 Can be Chemically Integrated Into Fibrin Published Findings Extend Tß4 ’s Potential Therapeutic Role August 17, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced that its wound healing drug candidate, Tß4, can be chemically integrated into fibrin and fibrinogen. This would potentially allow Tß4 to be combined with clotting agents and medical-grade adhesives, such as fibrin glue -- commonly used during surgery to close wounds -- to further improve or accelerate the healing process. The study was published in today’s issue of Biochemistry, a publication of the American Chemical Society (Vol. 43, Issue 33, pages 10748-10756). “This research has opened new and additional doors for the possible use of Tß4 to accelerate the healing of acute wounds associated with surgery, or even possibly those incurred on the battlefield. While clinical trials would have to be performed to establish the efficacy of Tß4 incorporated into fibrin glue, we have now identified the specific sites of integration and successfully combined the two proteins,” according to Dr. Allan Goldstein, one of the authors of the study and Chief Scientific Advisor to RegeneRx. Dr. Goldstein, who also chairs the department of biochemistry and molecular biology at The George Washington University Medical School, Washington, D.C. added, “This is a very important study as it provides the first scientific evidence supporting the feasibility of combining Tß4 and fibrin to potentially accelerate and improve the wound healing process.” Tß4 is a naturally occurring 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, and down-regulates a number of inflammatory cytokines and chemokines. 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. It has also recently been reported that Tß4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissues. Researchers at the National Institutes of Health (NIH), and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that Tß4 is effective in accelerating dermal and corneal wounds in several 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 over forty 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 be initiated shortly. Recently, Tß4 was designated an “Orphan Drug” by the U.S. FDA, thus extending the period of market exclusivity and allowing the company to be eligible for FDA grants, among other benefits. 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 regulatory approval process and 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 clinical trials, 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. |
