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RegeneRx to Begin Human Clinical Trials For Novel Wound Healing Drug RegeneRx to Begin Human Clinical Trials For Novel Wound Healing Drug FDA Allows First Human Testing of Thymosin Beta 4 December 19, 2002 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) announced that the U.S. FDA has accepted its Investigational New Drug Application (IND) allowing the company to begin Phase I human clinical trials for its drug, Thymosin beta 4 (Tß4). The company anticipates initiating the clinical trials early next year to evaluate the safety and efficacy of Tß4 for the treatment of chronic dermal wounds. The IND was filed with the FDA on November 18th. According to J.J. Finkelstein, RegeneRx's President & CEO, "Obviously, this is an important milestone for RegeneRx and we are pleased to be in a position to begin human clinical trials. Even as we prepare to begin the trials, new data has been published by researchers at the UC Irvine and UCLA (Tang YQ, et al, Infection and Immunity, Dec 2002, pp. 6524-6533) indicating that Tß4 has anti-microbial activity that not only augments our wound healing efforts but also may offer additional opportunities for the drug beyond the treatment of chronic wounds. We are very excited that so much additional independent data is being generated that support our efforts." Tß4 is a naturally occurring 43 amino acid peptide and the major actin-sequestering molecule in mammalian cells. As such, it plays a vital role in the regeneration, remodeling, and healing of injured or damaged tissues. Tß4 is found in highest concentration in blood platelets, the first molecules to reach the site of a wound. It has also been shown to influence T-cell differentiation, decrease toxicity induced by endotoxin and chemotherapy, and down-regulate a number of key inflammatory cytokines and chemokines. Tß4 is the first actin-sequestering molecule to be tested for wound healing. It has a significantly different mechanism of action than other potential wound healing agents, including growth factors, and may be delivered topically, virtually eliminating toxicity while allowing easy accessibility for frequent treatment. Numerous recent papers have been published in major scientific journals describing the results of research on Tß4 conducted at the NIH and other institutions. Abstracts of these publications may be found at the company's web site. RegeneRx Biopharmaceuticals, Inc., Bethesda, MD, (www.RegeneRx.com) holds an exclusive worldwide license for Tß4 from NIH for wound healing and is developing it for the potential treatment of a variety of human diseases. The Company holds several patents related to the technology and has numerous patent applications pending. RegeneRx expects to initiate human clinical trials for chronic dermal wounds early next year. Earlier this year, the Company completed a $1.7 million equity investment round that included investment by a major private European pharmaceutical group. 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. |
