RegeneRx Announces Completion of Patient Enrollment In Phase 2b/3 U.S. Dry Eye Trial

Jan 29, 2016, 08:33 ET from RegeneRx Biopharmaceuticals, Inc.

ROCKVILLE, Md., Jan. 29, 2016 /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 U.S. joint venture with G-treeBNT, ReGenTree LLC, has completed enrollment of its Phase 2b/3 dry eye trial in the U.S.  The trial is testing RGN-259 (Thymosin beta 4), a sterile, preservative-free eye drop developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders. 

The co-primary endpoints are assessments of total corneal staining and reduction of ocular discomfort in patients using RGN-259 compared to those using placebo.  Patients will use the eye drops 4 times daily for 28 days and be assessed periodically throughout the trial and at completion of treatment.  There will be numerous secondary endpoints that will also be evaluated pursuant to the trial protocol.

"Completion of enrollment for the dry eye study marks a key milestone.  Treatment and patient follow-up should be completed in February with data analysis shortly thereafter.  Everyone involved in the study is looking forward to the efficacy analysis and toward commercial development of RGN-259 for this underserved market.  Positive results should also have a significant impact in the development cycle for our product candidate in Asia, Europe, and other markets throughout the world, as well as in its development for other ocular indications," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

About ReGenTree, LLC

ReGenTree, LLC is a newly created U.S. joint venture company owned by G-treeBNT Co., Ltd., a bio venture company in Korea and RegeneRx Biopharmaceuticals, Inc., a clinical stage drug development company in the U.S. ReGenTree is developing a novel therapeutic peptide, RGN-259 (designated GBT-201 in Korea), in the U.S. for ophthalmic indications.

G-treeBNT holds a major equity stake in ReGenTree and is responsible for conducting and funding all clinical trials and product development.  RegeneRx also holds a significant equity stake in the joint venture in addition to a royalty on future sales of any product developed by the venture, and has contributed all of its related intellectual property and non-clinical and clinical data generated to date.  The three-member ReGenTree board of directors includes one member each from the two founding companies and one independent director.

ReGenTree seeks to become a top pharmaceutical company specializing in ophthalmology. It is currently conducting a Phase 2b/3 and a Phase 3 clinical trial in the U.S. to develop treatments for dry eye syndrome and for neurotrophic keratopathy (a rare disease with orphan designation by the U.S. FDA) with RGN-259/GBT-201. RGN-259/GBT-201 is a sterile, preservative-free eye drop formulation using Blow-Fill-Seal technology and the novel compound, thymosin beta 4 (Tβ4), as its active pharmaceutical ingredient.

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 Tβ4-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 2b/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 2016.  RGN-259 is also under development in Asia through RegeneRx's two Asian partnerships.  RGN-352, the Company's Tβ4-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 neurological pathologies such as peripheral neuropathy.  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 expected timing of initiation and completion clinical trials in the United States and the potential benefits to RegeneRx of such trials. There can be no assurance that any proposed clinical trial will be completed within the estimated timeframe or that positive results from any clinical trials by the Company or its collaborators, in the U.S. or any other country, will result in subsequent clinical confirmation, regulatory approval in the U.S. or elsewhere, 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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