ROCKVILLE, Md., May 13, 2010 (BUSINESS WIRE) --RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that it has been awarded a $3 million grant from the National Institutes of Health's National Heart, Lung and Blood Institute to support and accelerate the clinical development of its novel product candidate RGN-352, an injectable formulation of the novel therapeutic peptide Thymosin beta 4, or TB4, for patients who have suffered an acute myocardial infarction, or AMI, commonly known as a heart attack. The award is being issued under the American Reinvestment and Recovery Act of 2009. The Company is planning to initiate a Phase 2 clinical trial with RGN-352 later this year.

This highly competitive grant award will allow the Company to conduct a number of key scientific activities in parallel that should facilitate the commercial development of RGN-352.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the development of TB4 for tissue and organ protection, repair and regeneration. In published preclinical studies, TB4 has been shown to significantly reduce myocardial scar volume, regenerate myocardial tissue, and improve cardiac function after an ischemic event. Currently, RegeneRx has formulated three product candidates in clinical development: RGN-352, an injectable formulation for systemic delivery to treat cardiovascular diseases, central nervous system diseases, and other medical indications that require administration by injection, that has completed a Phase 1 clinical trial; RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications that is currently in Phase 2; and RGN-137, a topically applied gel for chronic dermal wounds and reduction of scar tissue that is the subject of a Phase 2 clinical trial for the treatment of epidermolysis bullosa. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack, although recent animal research suggests that this formulation may also benefit patients with multiple sclerosis and stroke. RegeneRx has a fourth product candidate, RGN-457, which is an inhaled formulation targeting cystic fibrosis and other pulmonary diseases, in pre-clinical development. These product candidates are based on TB4, a synthetic copy of a 43-amino acid, naturally-occurring peptide that is the subject of an exclusive worldwide license from the National Institutes of Health. In addition to the four pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of TB4 for potential cosmeceutical use. RegeneRx holds over 60 worldwide patents and patent applications related to its product candidates.

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements 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. These forward-looking statements include statements regarding the receipt of grant funding from the NIH and the proposed clinical development of RGN-352. You are urged to consider statements that include the words "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may," "potential" or the negative of those words or other similar expressions words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include our ability to satisfy the terms and conditions of the grant award, as well as the risks and uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in future clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" sections of the annual report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 31, 2009, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

SOURCE: RegeneRx Biopharmaceuticals, Inc.

For RegeneRx:
Lori Smith, 301-208-9191