RegeneRx Updates on U.S. Ophthalmic Clinical Trials

21 Oct, 2015, 08:52 ET from RegeneRx Biopharmaceuticals, Inc.

ROCKVILLE, Md., Oct. 21, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or the "Company"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today is providing an update on the status of its ophthalmic clinical program in the U.S.

On September 16, ReGenTree, LLC, a U.S. joint venture owned by G-treeBNT Co., Ltd, and RegeneRx specifically created to develop RGN-259 in the U.S. for ocular disorders, began enrollment and treatment of patients with dry eye syndrome (DES) and neurotrophic keratopathy (NK) in two separate clinical trials.  The DES trial is a Phase 2b/3 study, being conducted by Ora Inc., an established contract research organization specializing in the field of ophthalmology, at several sites in New England.  The NK trial is a Phase 3 trial, also being conducted by Ora Inc., at eight sites in the Eastern U.S., including several major medical centers. Both clinical trials are randomized, double-masked, placebo-controlled studies.

To date, the DES trial has enrolled over 125 of 350 patients or just over 33%.  The NK trial, a smaller study in an orphan population, has enrolled several patients thus far with a goal of 46.  Both trials are progressing as planned and are expected to be completed in early 2016 with results reported as soon as practicable thereafter.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, 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 worldwide patents and patent applications 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 has Phase 3 clinical trials with RGN-259 for the treatment of patients with NK.  The drug candidate will also be tested in patients with dry eye syndrome in the U.S. and Asia.  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.

About RGN-259

RGN-259 (designated GBT-201 in Korea) is a sterile, preservative-free eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4). Based on U.S. Phase 2 clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures.  The data from these trials, as well as a recently completed clinical trial of RGN-259 in patients with neurotrophic keratopathy, reflect RGN-259's mechanisms of action, support the "protective" effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials.  Dry eye syndrome is a multifactorial disease and it is well known that TB4 promotes cell migration and proliferation, modulates cytokines and/or chemokines related to inflammation, matures stem cells, and stimulates cell survival, all of which are believed to be important for effective treatment of DES.

About ReGenTree LLC

ReGenTree is a newly created U.S. joint venture company owned by G-treeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259/GBT-201 in the U.S. for ophthalmic indications.  ReGenTree licensed the rights to RGN-259 from RegeneRx in January of 2015 and is initiating Phase 2b/3 and Phase 3 clinical trials in patients with dry eye syndrome and neurotrophic keratopathy (an orphan indication) in September 2015.  Results from the trials are expected in March/April 2016.  RegeneRx retains a significant minority interest in the joint venture, along with a royalty on commercial sales, and is represented on the board of ReGenTree.  Certain commercial and financial transactions require RegeneRx approval.  G-treeBNT is responsible for operations of the venture and all funding required for clinical development of RGN-259/GBT-201 in the U.S.

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 expected procedure, timing and results of clinical trials in the United States and the potential benefits to RegeneRx of such trials. There can be no assurance that any clinical trial will start or complete within the estimated timeframe or that positive results from any clinical trial 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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http://www.regenerx.com