RGN Regenerx Biopharmaceuticals

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the Company” or “RegeneRx”) announced that scientists have identified a long sought-after extracellular signaling pathway and receptor for thymosin beta 4 (Tβ4). The observation that Tβ4 increases cell surface ATP (energy produced by cells), could explain its ability to protect and regenerate tissue after ischemic injury and hypoxia (oxygen deficiency). The paper, published in the FASEB Journal, November 24, 2010, also highlights Tβ4’s ability to activate specific molecules on the surface of human endothelial cells that are involved in vascular reactivity, apoptosis (natural cell death) and secretion of cytokines (immunoregulatory molecules). The data further elaborate Tβ4’s involvement in other diverse biological activities such as cell migration, inflammation, and angiogenesis.

“This group has found the key to addressing the multiplicity of activities of Tβ4. Since there are several molecules, called antagonists that could block this receptor, the paper will likely open up a large number of areas of research on Tβ4 to explore this activity at the cellular level. It is an important paper and the first identification and characterization of a Tβ4 receptor,” stated Allan L. Goldstein, Ph.D., Professor of Biochemistry and Molecular Biology at The George Washington University School of Medicine and Founder and Chief Scientific Advisor of RegeneRx.

The paper, Regenerative Protein Thymosin β-4 is a Novel Regulator of Purinergic Signaling, was published in the FASEB Journal, November 24, 2010. The research was conducted by Drs. Kevin Freeman, Brian Bowman and Bruce Zetter of the Vascular Biology Program and Department of Surgery at The Children’s Hospital and Harvard Medical School. The researchers have no affiliation with RegeneRx.

About RegeneRx Biopharmaceuticals, Inc.

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-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. The company has initiated a Phase 2 clinical trial and expects to enroll the first patient by early 2011 at approximately 25 clinical sites in the U.S., Israel, and Russia. RegeneRx is also supporting a Phase 1/2 physician-sponsored clinical trial in patients with multiple sclerosis that is expected to begin in 2011. RegeneRx recently received a $3 million, three-year development grant from the NIH to support the company’s acute myocardial infarction program.

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on recent human clinical data, RegeneRx is currently supporting a physician-sponsored Phase 2 dry eye study with RGN-259. Previously, seven patients with non-healing corneal ulcers were treated with RGN-259 under compassionate use INDs. Five had complete healing and two had substantial healing of their wounds. Three additional patients with corneal defects, called punctate keratitis, had no evidence of healing although they did report reduction in eye inflammation and increased comfort.

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.

In addition to the pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds numerous patents and patent applications worldwide related to its products and holds an exclusive worldwide license from the National Institutes of Health, as well as other licenses related to Tβ4. The Company recently received $733,438 in funding under the Patient Protection and Affordable Care Act to support each of 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. You are urged to consider statements that include the words “believe,” “plan,” “expect,” “intend,” “could,” “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 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 non-clinical or 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, 2009, filed with the SEC on March 31, 2010, and the quarterly report on Form 10-Q for the quarter ended September 30, 2010, 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.

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