RegeneRx Receives $500,000 Milestone Payment With Enrollment of First Patient in U.S. Phase 2b/3 Dry Eye Trial

Sep 30, 2015, 13:54 ET from RegeneRx Biopharmaceuticals, Inc.

ROCKVILLE, Md., Sept. 30, 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 announced that it has received a milestone payment of $500,000 from ReGenTree, LLC, its U.S. joint venture with G-TreeBNT Co. Ltd., after enrollment of the first patient in a U.S. ophthalmic clinical trial sponsored by ReGenTree.  ReGenTree recently began enrolling patients in a Phase 3 trial for neurotrophic keratopathy (an orphan indication) and a Phase 2b/3 trial for dry eye syndrome, both in the U.S.  RegeneRx received an earlier payment of $500,000 when the joint venture was created this year to develop RGN-259 (designated GBT-201 in Korea). 

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4).  In two 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.  Data from these trials, as well as a previous clinical trial of RGN-259 in patients with neurotrophic keratopathy (NK), reflect RGN-259's mechanisms of action, support the "protective" effects of RGN-259, and provide FDA-approvable clinical endpoints targeted in the current dry eye trial.

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.  RegeneRx has Phase 3 clinical trials with RGN-259 for the treatment of patients with NK.  The drug candidate is also being 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 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 initiated 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 timing of completion of clinical trials in the United States and the potential benefits to RegeneRx of such trials; status of other clinical assets; and scope of patents and patent applications. There can be no assurance that any clinical trial will 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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