G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

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.


RegeneRx Biopharmaceuticals, Inc.


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