RegeneRx Provides Update on Clinical Trials in U.S., Korea and China

Aug 06, 2015, 08:30 ET from RegeneRx Biopharmaceuticals, Inc.

ROCKVILLE, Md., Aug. 6, 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 provided an update on the status and timing of the four ophthalmic clinical trials for dry eye syndrome and neurotrophic keratopathy (NK) scheduled to commence in the U.S., Korea, and China this year.  In Korea and China the dry eye trials are being sponsored by RegeneRx's strategic partners in their respective territories.  In the U.S., the dry eye and NK clinical trials are being sponsored by ReGenTree, LLC, a joint venture between RegeneRx and G-treeBNT.  RGN-259/GBT-201 is a sterile, preservative-free ophthalmic eye drop that is being tested in the trials.

Representatives of G-treeBNT and RegeneRx recently met with the U.S. Food and Drug Administration to finalize details of the Phase IIb/III trial in patients with dry eye syndrome, which is being sponsored by ReGenTree, LLC.  Based on the positive outcome of the meeting, ReGenTree is preparing to enroll patients in the U.S. dry eye and NK clinical trials in September 2015. The Phase IIb/III dry eye trial is expected to be completed during the first half of 2016 and the Phase III NK trial is expected to be completed in the second half of 2016, or sooner, depending on the speed of patient accrual for this orphan indication.  Additionally, ReGenTree has successfully completed the manufacturing required for Phase III and RGN-259 will soon be shipped to the contract research organization (CRO) managing the clinical trials in the U.S. 

G-treeBNT recently received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase IIb/III clinical trial for dry eye syndrome in Korea.  Given the immediate focus of the two U.S. trials, G‑treeBNT is considering the best timing of the Korean trial.

The fourth clinical trial, a Phase II dry eye trial in China is awaiting clearance to start enrollment by the Chinese Food and Drug Administration (CFDA).  RegeneRx intends to provide further updates on all trials as appropriate.

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

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 an extensive worldwide patent portfolio covering its products.  RGN-259, the Company's Tβ4-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.  The drug candidate is also being studied in patients with dry eye syndrome in the U.S. and Asia.  RegeneRx, through its U.S. joint venture, ReGenTree LLC, is developing RGN-259 in the United States and expects to initiate a Phase IIb/III trial later this year. RGN-352, the Company's TB4-based injectable, 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.  Forward-looking statements used in this press release relate to, among other things, the expected timing of our clinical trials in the United States, Korea, and China.  There can be no assurance that any proposed 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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