ROCKVILLE, Md., March 9, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx") has been notified that its joint venture partner and licensee, G-treeBNT Co. Ltd., will receive $7.28 million USD to expand international development of its product candidate, RGN-259 (designated GBT-201).
G-treeBNT will receive a $5.92 million investment from Global Pharmaceutical Industry Development Fund, which was raised in September, 2013 to support selected Korean pharma or bioventure firms developing new drugs for the global market. This specialized fund was created by the Korean Ministry of Health and Welfare and is managed by InterVest which is a leading healthcare venture capital firm in Korea.
G-treeBNT will also receive an additional $1.36 million investment from E&Investment, a Korean venture capital firm. The $7.28 million will be used for development of RGN-259/GBT-201 for dry eye syndrome and neurotrophic keratopathy in the U.S. through a recently created U.S. joint venture between G-treeBNT and RegeneRx, ReGenTree, LLC.
"This very significant investment is directed at U.S. clinical development of RGN-259/GBT-201 through our joint venture, ReGenTree, LLC, and certainly speaks highly of G-treeBNT's status and product opportunities among its Korean peers. This will provide a sizable amount of new capital for the joint venture and should definitely expedite clinical development," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.
"I expect that investment by the Global Pharmaceutical Industry Development Fund through the Korean Ministry of Health and Welfare and InterVest will be a great opportunity to become a global biopharmaceutical company with GBT-201/RGN-259. In the near future G-treeBNT and its U.S. joint venture entity, ReGenTree, will seek to become an outstanding specialty biopharmaceutical company that will be very unique and very strong in a niche worldwide market based on successful development of its proprietary drug development in the U.S. and Pan Asia," stated Won S. Yang, president and chief executive officer of G-treeBNT.
About RGN-259 (GBT-201) for the Treatment of Dry Eye Syndrome
RGN-259 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 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.
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, neural, 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 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.
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 expects to begin Phase IIb and Phase III clinical trials in patients with dry eye syndrome and neurotrophic keratopathy (an orphan indication) this year.
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.
SOURCE RegeneRx Biopharmaceuticals, Inc.