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Researchers Report New Data on TB4's Ability to Reduce Heart Attack Damage
[June 06, 2011]

Researchers Report New Data on TB4's Ability to Reduce Heart Attack Damage


ROCKVILLE, Md. --(Business Wire)--

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") has announced that researchers have shown that Tß4 has more extensive beneficial effects on the myocardium after heart attack than previously reported. The research team also confirmed previous reports that Tß4 activates the Akt survival kinase and protects cardiac muscle cells from apoptosis (programmed cell death), that the infarct sizes were smaller and cardiac function significantly improved in mice receiving Tß4, and that Tß4-treated mice had a significant reduction in cardiac fibrosis (scarring) due to the reduction of collagen expression.

For the first time in a myocardial infarction model, researchers showed that Tß4 suppresses NF-?B, a protein complex that regulates the expression of inflammatory molecules that cause damage during and after a heart attack. Previously published research showed that Tß4 suppresses NF-?B after damage in the eye.

The research was conducted by Sudhiranjan Gupta, Ph.D. and his colleagues in the Division of Cardiology, Cardiovascular Research Institute, Texas A&M Health Science Center, Temple, Texas, and Departments of Stem Cell and Regenerative Medicine and Molecular Cardiology, Lerner Research Institute, Cleveland Clinic, Cleveland Ohio. The research was published in PLoS ONE, May 2011, Vol 6, Issue 5, 1-10.

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 product candidates.

RGN-259 is a sterie, 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 and has completed to animal studies showing RGN-259's positive effects on dry eye symptoms. 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-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications. 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 at approximately 20 clinical sites in the U.S., Israel, and Russia, although this trial is currently on an FDA-imposed clinical hold. RegeneRx recently 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.


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 "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 current clinical trials or 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 (News - Alert)"), 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.


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