ROCKVILLE, Md., March 25, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or the "Company") has received an initial payment of $500,000 from ReGenTree, LLC, its U.S. joint venture with G-TreeBNT Co. Ltd., pursuant to a license of RGN-259 for ophthalmic indications to ReGenTree. RegeneRx expects to receive a second payment of $500,000 later this year upon enrollment of the first patient in a U.S. ophthalmic clinical trial sponsored by ReGenTree. ReGenTree is planning a Phase III trial for neurotrophic keratopathy (an orphan indication) and a Phase II trial for dry eye syndrome in the U.S., both to begin later this year.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (Tβ4). In 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 subsequent 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 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 ReGenTree, LLC
ReGenTree is a newly created U.S. joint venture company owned by RegeneRx Biopharmaceuticals, Inc. and G-treeBNT Co. Ltd. specifically to develop RGN-259 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 II and Phase III clinical trials in patients with dry eye syndrome and neurotrophic keratopathy (an orphan indication), respectively, this year.
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 GBT-201 (RGN-259) in Korea, G-treeBNT's goals with respect to marketing GBT-201 in Korea 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, start-date, 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.