RegeneRx Korean Licensee Receives Government Approval to Conduct Phase 2b/3 Clinical Trial in Patients with Dry Eye Syndrome

Jul 17, 2015, 11:00 ET from RegeneRx Biopharmaceuticals, Inc.

ROCKVILLE, Md., July 17, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, was informed today by its licensee, GtreeBNT Co. Ltd. (Gtree), headquartered in Gyeonggi-do, South Korea, that it has received approval from the Ministry of Food and Drug Safety (MFDS) in Korea to conduct a Phase 2b/3 clinical trial in patients with dry eye syndrome (DES).

The Phase 2b/3 clinical trial will be a multicenter, randomized, double-masked study that will be conducted in approximately 360 patients with DES.  The trial will evaluate the efficacy and superiority of GBT-201 compared to placebo.  GBT-201/RGN-259 is a sterile, preservative-free eye drop designed to treat eye disorders such as DES and neurotrophic keratopathy (NK), among others.  According to Gtree, it is the first pharmaceutical company in Korea to reach Phase 3 clinical trial status for a new drug for the treatment of DES.

"Approval to initiate the Korean dry eye study represents a significant milestone for GBT-201/RGN-259.  The Gtree team has been working very hard to prepare for this clinical trial, and we have been working closely with them to help expedite this effort.  Patient enrollment is targeted for the end of September, and we look forward to receiving notice when the first patient is enrolled," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

About RGN-259 (GBT-201) for the Treatment of Dry Eye Syndrome

RGN-259 (designated GBT-201 in Korea) is a sterile, preservative-free topical 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 NK, 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 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 TB4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy.  RegeneRx was recently allowed by the FDA to move into Phase 3 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 2b/3 trial later this year.  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 G-treeBNT Co. Ltd.

G-treeBNT recently entered the biopharmaceutical industry through carefully selected strategic alliances with distinguished leading bio-venture companies in the US and EU.  The strategic alliance with RegeneRx was the first strategic investment in its mission to create a multi-national biopharmaceutical company. Currently the company is developing GBT-201, its first drug candidate for dry eye syndrome in 28 Asian and Pacific Rim countries, has recently received an IND for a Phase 2b/3 clinical trial in Korea, and has assembled an accomplished pharmaceutical team to carry out its mission.

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 and Korea. 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.



RELATED LINKS

http://www.regenerx.com