Healthcare Industry News:  thymosin beta 

Biopharmaceuticals Wound Care

 News Release - September 11, 2007

RegeneRx Receives U.S. Patent for Wound Healing Technology

BETHESDA, Md.--(HSMN NewsFeed)--RegeneRx Biopharmaceuticals, Inc. (Amex:RGN ; announced today that a U.S. patent related to wound healing has been issued by the U.S. Patent and Trademark Office. The patent claims are based on a significant body of data developed by the National Institutes of Health and include numerous claims relating to thymosin beta 4 (TB4), its analogues, related compounds, fragments and other variants.

TB4's wound healing properties are the subject of four RegeneRx-sponsored Phase 2 clinical trials in chronic pressure ulcers; venous stasis ulcers; epidermolysis bullosa, a difficult-to-heal skin blistering disease and orphan indication; and diabetic patients undergoing corneal surgery. The Company is also sponsoring a Phase 1 clinical trial in healthy volunteers to assess the safety of its injectable formulation for use in heart attack patients.

"We are very pleased to receive this important patent. It not only addresses our current product development efforts, but also covers future business opportunities while protecting us against others using our technology in related areas. We look forward to the issuance of additional patents in the U.S. and abroad in the coming months," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Currently, RegeneRx is developing TB4, a 43 amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that TB4 may prove efficacious for multiple indications; therefore, RegeneRx is developing TB4 as the cornerstone of its therapeutic platform. The technology platform has many potential applications in both the pharmaceutical and consumer products sectors. RegeneRx holds nearly 60 world-wide patents and patent applications related to dermal, ophthalmic, and internal wounds and tissue repair, cardiac and neurological injuries, septic shock and several consumer product areas. RegeneRx is currently sponsoring three Phase 2 chronic dermal wound healing clinical trials, a Phase 2 ophthalmic trial, and a Phase 1A cardiovascular clinical trial as part of its ongoing clinical development program.

The RegeneRx Technology Platform

TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. One of TB4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement. Of the thousands of proteins in cells, actin represents up to 10% of the total protein and, thus, plays a major role in the physiology of the cell. RegeneRx has identified several molecular variations of TB4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the U.S., have published numerous scientific articles indicating that TB4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. In two articles published in the scientific journal, Nature, researchers found that TB4 protects heart tissue following a myocardial infarction and can regenerate coronary vessels in laboratory animals. Abstracts of scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page:

Safe Harbor Statement

The information in this press release may include certain forward-looking statements, including without limitation statements such as "believe," "estimate," "expect," and "target," 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 of TB4 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 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-K. 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.

Source: RegeneRx Biopharmaceuticals

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