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RegeneRx Receives Patent for Reversal of Skin Aging in Japan

Tuesday, January 13, 2009

First Patent for Company’s Product Candidates Issued in Japan

Bethesda, MD -- RegeneRx Biopharmaceuticals, Inc. (NYSE Alternext:RGN) announced today that it received notice of patent allowance from the Japanese Patent Office for "Inhibition or Reversal of Skin Aging by Actin-Sequestering Peptides". This patent covers use of thymosin ß4 (Tß4) for promoting improvement of skin conditions including elasticity, and reduction and lightening of age-related skin abnormalities.

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. The Company is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tß4, 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 three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.

RegeneRx Technology Background

Tß4 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 Tß4 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 Tß4’s in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to Tß4’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 Tß4'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 value of patents related to reversal of skin aging, the company’s ability to capitalize on the patent described in this release, the company’s ability to enter into any collaborations with respect to the development or commercialization of its product candidates, and the therapeutic potential of Tß4 for dermal, ophthalmic, and cardiovascular wounds, pulmonary and cosmeceutical 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 although Tß4 and its fragments have 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 the company’s 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 the company 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.

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