RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) announced that it has filed an Investigational New Drug Application (IND) with the U.S. FDA requesting permission to begin a Phase 1 human clinical trial for Thymosin beta 4 (Tß4). If the FDA allows the IND to become effective, the company anticipates initiating the clinical trial early next year to evaluate the safety and efficacy of Tß4 for the treatment of chronic dermal wounds.

According to J.J. Finkelstein, RegeneRx's President & CEO, "We have been diligently working toward this goal over the past several years and look forward to the initiation of the first human clinical trials with Tß4. Our focus will be to determine whether the results obtained by the National Institutes of Health (NIH) and other institutions using Tß4 to effectively repair dermal and ocular wounds in various animal models can be replicated in humans. Tß4 has been shown to significantly accelerate wound healing in normal, diabetic, steroid-suppressed, and aged animals."

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 by the end of this year. Earlier this year, the Company completed a $1.7 million equity investment round that included investment by a major private European pharmaceutical group.

Filing of an IND is required prior to initiation of human clinical trials in the U.S. Once the FDA allows the IND to go into effect, clinical trials may be initiated. Typically, clinical evaluation involves a three stage process to assess safety and efficacy, after which the sponsor may file a New Drug Application (NDA) requesting FDA approval for commercial marketing.

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.

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