Researchers Find RegeneRx's TB4 Inhibits Activation of Key Inflammatory Molecule - NFkB

BETHESDA, Md.--(BUSINESS WIRE)--Jan 23, 2007 - RegeneRx Biopharmaceuticals, Inc. (Amex:RGN) (www.regenerx.com) reported today that researchers at the Wayne State University School of Medicine and the Kresge Eye Institute in Detroit, Michigan, found that thymosin beta 4 (TB4) inhibits the activation and nuclear translocation of the transcription factor NFkB, (pronounced: N-F-kappa-B), widely implicated as a major regulator of inflammatory response. The research team, headed by Gabriel Sosne, M.D., Assistant Professor of Ophthalmology and Anatomy/Cell Biology at the Kresge Eye Institute, of the Wayne State University School of Medicine, published their latest findings in Experimental Eye Research, January 23, 2007. Dr. Sosne is a member of RegeneRx's Medical and Scientific Advisory Board.

"The discovery and identification of novel agents that can mitigate the adverse host inflammatory/immune responses to diseases and injuries would be a major therapeutic breakthrough and could have significant cost benefits as well," according to Dr. Sosne. "Emerging evidence from our laboratory shows that TB4 has significant potential for development as a drug candidate in indications where an over-active immune response may exacerbate the original injury and/or be detrimental to the patient's recovery. Since NFkB activation and translocation are involved in such a wide array of inflammatory-based entities, these findings may also help us better understand how TB4 regulates physiological processes such as wound repair, suppressing inflammation and inhibiting apoptosis."

Inflammation is part of the host immune response to tissue injury and is linked to a wide spectrum of potentially debilitating diseases including diabetes, asthma, inflammatory bowel disease, rheumatoid arthritis, cardiovascular disease, the common cold, cancer and HIV/AIDS, as well as traumatic injuries associated with the brain and spinal cord. The increasing prevalence, economic burden, morbidity, and mortality from these and other inflammatory-related diseases and injuries are major public health issues.

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, ocular, 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 and has additionally targeted ophthalmic and cardiac trials in 2007 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 (heart attack) 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: www.regenerx.com.

Safe Harbor Statement

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 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-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.

Contact

RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelstein, 301-280-1992
jjfnk@regenerx.com

Posted: January 2007

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