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Clinical Results with RegeneRx's Ophthalmic Drug Candidate Subject of Oral Presentation at 2009 ARVO Meeting

RGN-259 Had Positive Results in Four Patients with Non-Healing Corneal Ulcers

BETHESDA, Md.--(BUSINESS WIRE)--Feb 23, 2009 - REGENERX BIOPHARMACEUTICALS, INC. (NYSE Alternext US:RGN) announced today that an oral presentation entitled “The Use of Thymosin Beta 4 to Promote Healing of Neurotrophic Corneal Ulcers” will be presented at the 2009 Association for Research in Vision and Ophthalmology (ARVO) on Tuesday, May 5, at 3:45 p.m. ET in Ft. Lauderdale, Florida. The presentation will report on the healing effects of RGN-259 eye drops in patients with non-healing corneal ulcers. Dr. Gabriel Sosne, Associate Professor of Ophthalmology at Wayne State University School of Medicine and a member of RegeneRx's Medical and Scientific Advisory Board will be presenting the clinical data.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. RegeneRx is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides and is currently sponsoring multiple clinical trials in dermal and ophthalmic wound healing and protection of the heart after an acute myocardial infarction.

RegeneRx Technology Background

Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of Tβ4 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 Tβ4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to Tβ4's effects in the eye have been published in Investigative Ophthalmology and Visual Science, Experimental Cell Research, and Experimental Eye Research, among others. Abstracts of these and other scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page:

Forward-Looking Statements

This press release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Examples of such forward-looking statements include statements concerning the wound healing effects of RGN-257 in ophthalmic indications, including non-healing neurotrophic keratitis ulcers, the safety and efficacy of RGN-259, the company's ability to enter into any collaborations with respect to the development or commercialization of any of its product candidates, and the therapeutic potential of Tβ4 for dermal, ophthalmic, and cardiovascular wounds and pulmonary indications. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that the compassionate use results were based on a very small number of patients and such results may not be observed in a larger patient population, although Tβ4 has demonstrated potential therapeutic benefit, the company's product candidates may not demonstrate safety and/or efficacy in clinical trials, the risk that the company or its collaborators will not obtain approval to market the company's product candidates in the U.S. or abroad, the risks associated with the company's need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to its product candidates, the risks associated with protecting the company's intellectual property, or that the company will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in the company's quarterly report on Form 10-Q for the period ended September 30, 2008, and other filings it makes with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. The company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.


Contact: RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelstein, 301-280-1992



Posted: February 2009