RegeneRx Joint Venture Posts Results of Severe Dry Eye Trial On ClinicalTrials.gov

ROCKVILLE, Md., Dec. 23, 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 that its joint venture with G-treeBNT, ReGenTree LLC, has posted final results from the first placebo-controlled, double-masked, exploratory Phase 2 clinical trial using RGN-259 eye drops in patients with severe dry eye on www.clinicaltrials.gov (search "thymosin and severe dry eye"), which were previously published earlier this year in the medical journal, Cornea; May 2015;34:491-496. 

The data demonstrated statistically significant improvements of corneal damage and ocular discomfort (signs and symptoms) in patients with severe dry eye, meeting the trial's key efficacy objectives.  Moreover, improvements were seen at 28 days after cessation of treatment, supporting durability of the treatment.  Other improvements seen in the trial included tear film breakup time and increased tear volume production.  There were no adverse events. 

The pilot study was conducted in 9 patients (18 eyes) with severe dry eye, mostly associated with graft vs. host disease (GvHD) and Sjogren's syndrome, at Kresge Eye Institute of Wayne State University School of Medicine and Michigan Corneal Consultants in Detroit Michigan.  It should be noted that severe dry eye is not the target of the currently ongoing Phase 2/3 clinical trial in the U.S. being sponsored by ReGenTree LLC, in patients with moderate to severe dry eye, which represents the largest segment of the dry eye population.

"TB4 [the active ingredient in RGN-259 eye drops] is proving to be an effective treatment for dry eye in humans.  It improves the signs and symptoms in patients with severe dry eye and is relatively fast and long acting compared with other treatments in current use.  Future trials will need to include a larger cohort of patients and test additional doses for efficacy," according to the authors of the publication.

About Severe Dry Eye and RGN-259

Severe dry eye can have a significant impact on the patients' quality of life and may result in corneal ulcers and serious visual impairment. Conventional treatments using artificial tears and ointment, serum tears, and punctal occlusion have been of limited value in managing these problems. The inflammatory character of dry eye has led to the evaluation of various immunosuppressive and anti-inflammatory agents, none of which has led to the resolution of severe dry eye and surface healing problems. The introduction of a therapeutic agent that could reduce inflammation and accelerate ocular surface healing would reduce the risk and incidence of corneal morbidity in these patients susceptible to the disease and would result in an improvement in vision, lessening of light sensitivity, and greater comfort. RGN-259 (active ingredient: thymosin beta 4) has been shown to have a positive effect on epithelial migration and healing as well as an anti-inflammatory effect through a number of different pathways in the laboratory and in patients with diabetic and neurotrophic corneal defects. These features make RGN-259 a promising therapeutic agent for management of dry eye problems in general and in patients with GvHD, specifically.

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

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 and its constituent fragments, 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 the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.  RGN-259, the Company's TB4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK).  In September 2015, RegeneRx, through its U.S joint venture, ReGenTree LLC, initiated a Phase 2/3 clinical trial in patients with dry eye syndrome and a Phase 3 clinical trial in patients with NK.  Both trials are being conducted in the U.S. and are estimated to be completed in early 2016.  RGN-259 will also be tested in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships.  RGN-352, the Company's TB4-based injectable formulation, is a Phase 2-ready drug candidate designed 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.  There can be no assurance that any current or future clinical trial will replicate previous animal or clinical data or result in approved products or future value.  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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