Fragment of RegeneRx?s T?4 Inhibits Activation of Liver Cells Responsible Fibrosis & Scar Formation

In Vitro Studies Have Important Clinical Implications

ROCKVILLE, Md.--(BUSINESS WIRE)--Apr 11, 2011 - RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) has announced that researchers have found that a fragment of Tβ4 has the ability to inhibit a type of liver cell responsible for fibrosis and scar formation by blocking the binding of AKT to actin. AKT is an important enzyme that regulates cell death; actin is responsible for cell contraction and movement. The molecule responsible for this activity is a seven amino acid fragment of Tβ4 known to be the acting binding domain of Tβ4.

According to the researchers these data make possible the development of a novel therapeutic that can specifically identify and target cells responsible for the excessive scarring seen in liver diseases such as cirrhosis, as well as potential pathologies of the lungs, kidneys and other organs.

The research team was led by Dr. Marcos Rojkind of the Department of Biochemistry and Molecular Biology at The George Washington University School of Medicine. The research results will be reported at the annual meeting of the American Society for Investigative Pathology held with the Federation of American Societies of Experimental Biology (FASEB) on Tuesday, April 12, 2011.

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

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 product candidates.

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 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”), 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, 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.

Contact: For RegeneRx:
Lippert/Heilshorn & Associates, Inc.
Kim Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com

 

 

Posted: April 2011

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