RegeneRx


Contact:

For RegeneRx:
Lori Smith
301-208-9191
las@regenerx.com

RegeneRx Issued Major U.S. Heart Patent

RegeneRx Issued Major U.S. Heart Patent

January 9, 2012 — Rockville, Md.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that it has been issued a patent from the U.S. Patent and Trademark Office claiming methods for treating, preventing, inhibiting or reducing tissue deterioration due to congestive heart failure disease using Thymosin beta 4 (Tβ4), its isoforms and fragments, and important analogs. Patent No. 8,093,214 is projected to expire in July 2027.

About RegeneRx
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development and has an extensive worldwide patent portfolio covering its products.

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on a recently completed Phase 2 clinical trial in patients with dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. We believe the positive results of this Phase 2 exploratory trial reflect RGN-259’s reported mechanisms of action and provide RegeneRx with FDA-approvable endpoints to be targeted in future clinical trials.

RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack. Recent pre-clinical efficacy data suggests that RGN-352 may also benefit patients with multiple sclerosis, stroke and traumatic brain injury. RegeneRx has successfully completed a Phase 1 clinical trial with RGN-352 in which the drug candidate was found to be safe and well-tolerated. In 2010, RegeneRx received a $3 million, three-year development grant from the NIH to support the company's acute myocardial infarction program.

RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a Phase 2 clinical trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue. RegeneRx previously received $675,000 in grants from the U.S. FDA to support this clinical trial.

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. These 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. You are urged to consider statements that include the words “expect,” “estimate,” “will,” “may,” “potential” or the negative of those words or other similar expressions 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 risks related to uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in 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” section of the annual report on Form 10-K for the year ended December 31, 2010, filed with the SEC on March 31, 2011, and subsequent quarterly reports filed on Form 10-Q, 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.

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