RegeneRx Partner Submits Phase IIB/III IND to Korean Health Authority for RGN-259 for the Treatment of Dry Eye Syndrome

ROCKVILLE, Md., Dec. 29, 2014 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx") announced that its strategic partner, G-treeBNT Co. Ltd., has filed an IND with the Korean Ministry of Food and Drug Safety (MFDS) for a Phase IIB/III clinical trial with RGN-259 (designated GBT-201 in Korea and the licensed Pan Asia territory) for the treatment of patients with dry eye syndrome.

"We are pleased G-treeBNT has filed an IND this year with MFDS as they stated they would last March when we entered into the partnership.  Moreover, they have assembled an extremely experienced team of pharmaceutical professionals who have accomplished quite a bit in a short period of time in order to file the IND.  We look forward to initiation of the trial in Korea in 2015, followed by other countries in Asia," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

"Our goal with GBT-201, a preservative-free eye drop (with Thymosin beta 4 as the active ingredient) for the treatment of dry eye syndrome, is to become a market leader within 3-4 years.  The global market for dry eye prescription medications was approximately $1.1 billion as of 2013, and we are devoting substantial resources to enter this market space by creating significant value with GBT-201, which is unique among approved products and product candidates for this indication.  The market demand for a new drug with an innovative mechanism of action is very high," stated Won S. Yang, president and chief executive officer of G-treeBNT.

G-treeBNT received exclusive development and commercialization rights in March 2014 from RegeneRx for RGN-259 (GBT-201) for dry eye syndrome in 28 Asian and Pacific Rim countries including Korea, Japan and Australia.  RegeneRx will receive royalties and milestone payments upon commercialization in the territory.

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

RGN-259 (GBT-201) is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4). Based on two U.S. Phase II 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 results from these trials reflect RGN-259's mechanisms of action, appear to support the "protective" effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials.

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 strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the EU, and has an extensive worldwide patent portfolio covering its products. RGN-259, the Company's ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK), which is a primary focus of RegeneRx's clinical development efforts in the U.S. RegeneRx was recently allowed by the FDA to move into Phase III clinical trials with RGN-259 for the treatment of patients with NK. 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 filed an IND for a Phase IIB/III 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. Such forward-looking statements include statements concerning the anticipated timing of the initiation by G-treeBNT of a clinical trial of RGN-259 in Korea, G-treeBNT's goals with respect to marketing RGN-259 and the potential market demand for such  product candidate; product competition, research and clinical development and future commercialization of the Company's drug candidates; the design and length of clinical trials; and other regulatory interaction in the U.S., Korea, and other licensed territories.  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. There can also be no assurance that any clinical trial undertaken by RegeneRx or its licensees will be commercially successful or that the FDA, MFDS or other government agency will not have additional comments, restrictions, or guidance revisions regarding future clinical development or drug applications. 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, 2013, 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.

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SOURCE RegeneRx Biopharmaceuticals, Inc.

Related Links

http://www.regenerx.com