RegeneRx Receives Notice of Allowance on U.S. Patent for Skin Protection and Repair

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company” or "RegeneRx”) announced today that the Company received a notice of allowance from the U.S. Patent and Trademark Office for one of the original patent applications submitted by the National Institutes of Health.

The patent contains claims directed to compositions for topical administration of Thymosin beta 4 (Tß4) to skin and to methods for improving or treating damage to skin, including from radiation or scar tissue, and to methods of regenerating or revitalizing skin tissue.

The patent is set to expire on July 29, 2019.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, 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. Recently, Zacks Small-Cap Research issued a second investment report on RegeneRx that can be downloaded at:

http://scr.zacks.com/show_report.php?t=UkdSWA

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.

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