New Publication Elaborates on TB4's Effects on Dry Eye Syndrome and Other Potential Ophthalmic Disorders

Aug 12, 2015, 09:13 ET from RegeneRx Biopharmaceuticals, Inc.

ROCKVILLE, Md., Aug. 12, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced a new peer-reviewed publication describing Thymosin beta 4's (TB4) effects on dry eye syndrome and its potential value for the treatment of other ophthalmic disorders. The authors of the paper explained how TB4's reported mechanisms of action help alleviate the signs and symptoms of dry eye by promoting stem cell recruitment and cell migration, reducing inflammation and apoptosis, enhancing cytoprotection, and promoting gene expression.  These multiple activities are responsible for a potential paradigm shift in the treatment of dry eye disorders.  Current treatments aim to keep the eye moist and let the natural repair process function, which can take months, if at all.  RGN-259, TB4 formulated as a sterile, preservative-free eye drop, is designed to protect and repair the injured dry eye and improve the rate and degree of healing.  It is currently in late clinical trials.

The authors also addressed additional ocular disorders that may be improved with TB4 treatment.  These are based on the defined mechanisms of action of the molecule in the eye and include blepharitis, graft vs. host disease, limbal stem cell deficiency, and following eye surgery such as post-refractive surgery.

The paper was authored by Drs. Gabriel Sosne and Hynda K. Kleinman and published in the scientific journal, IOVS, 2015 Aug; 56(9):5110-7.  Both researchers are consultants to RegeneRx Biopharmaceuticals, Inc.

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

RegeneRx is focused on the development of a novel therapeutic peptide, TB4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the U.S., and has an extensive worldwide patent portfolio covering its products.  RGN-259, the Company's TB4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK).  RegeneRx was recently allowed by the FDA to move into Phase III clinical trials with RGN-259 for the treatment of patients with NK and dry eye syndrome.  The drug candidate is also being studied in patients with dry eye syndrome in Asia.  RegeneRx, through its U.S. joint venture, ReGenTree LLC, is developing RGN-259 in the United States and expects to initiate U.S. clinical trials this quarter. RGN-352, the Company's TB4-based injectable drug candidate, is Phase 2-ready and developed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar traumatic injuries.  For additional information about RegeneRx please visit www.regenerx.com.

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. Any 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.  Forward-looking statements used in this press release relate to, among other things, the potential ophthalmic indications for RGN-259 and clinical trials related thereto. There can be no assurance that any ophthalmic clinical trial will start within the estimated initiation timeframe or be completed within the estimated timeframe or that positive results from any clinical trials or research by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value.  There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country.  Please view these 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, 2014, 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 specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

SOURCE RegeneRx Biopharmaceuticals, Inc.



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