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Researchers Show How TB4 Protects Human Stem Cells

First Study with Human Stem Cells Elaborates TB4’s Mechanism of Action

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ROCKVILLE, Md.--Jan. 6, 2010--(BUSINESS WIRE)--RegeneRx Biopharmaceuticals, Inc. (OTCBB: RGRX) (“the Company” or “RegeneRx”) reported that a team of cardiovascular researchers in China have shown that Tβ4 can protect endothelial progenitor cells (EPCs or stem cells) derived from the blood of healthy human volunteers. This is the first report of apoptosis inhibition by Tβ4 in human EPCs and demonstrates that Tβ4 acts not only by recruiting stem cells, but also by promoting their survival and allowing greater numbers of stem cells to reach injured tissue.

Previously, two American groups, led by Dr. Gabriel Sosne (Wayne State University) and Dr. Deepak Srivastava (Gladstone Cardiovascular Institute - University of California, San Francisco) published similar cell survival activities in several animal models in the eye and heart, respectively. This current study is the first to translate and extend these observations to human stems cells and to identify other key molecules and pathways involved in protecting cells from apoptosis (cell death) after injury. The work was performed by researchers in the Department of Cardiology, Biomedical Research Center, Zhejiang University, Zhejiang Province, China and published in the Journal of Cell Physiology, December 30, 2010 [Epub ahead of print].

“Preventing the death of EPCs by culturing cells with Tβ4, as shown in this study, is important in explaining how Tβ4 prevents damage and induces tissue regeneration after injury to the heart,” stated Allan L. Goldstein, Ph.D., Professor of Biochemistry and Molecular Biology at The George Washington University School of Medicine in Washington, DC and RegeneRx’s chief scientific advisor. “Since these data were generated using human cells, rather than animal cells, we believe it further supports the potential of using Tβ4 to recruit, protect and increase the viability of stem cells necessary for tissue regeneration after injury in humans.”

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 preclinical 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 current 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, 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.

Contact: For RegeneRx:
Lippert/Heilshorn & Associates, Inc.
Kim Golodetz, 212-838-3777
Bruce Voss, 310-691-7100


Posted: January 2011