Chinese FDA accepts Lee's IND for Phase 2 dry eye study

RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("RegeneRx") and Lee's Pharmaceutical Holdings Ltd. ("Lee's") today jointly announced that the Chinese FDA has accepted a Phase II IND for RGN-259 (thymosin beta 4-based, preservative-free eye drops) to be tested in patients with moderate to severe dry eye syndrome in China.

Lee's Pharmaceutical Holdings Ltd., headquartered in Hong Kong, is the sponsor of the clinical trial. RGN-259 is one of several product candidates licensed to Lee's by RegeneRx in China, Hong Kong, Macau and Taiwan. On 17^th June 2014, Lee's received the official CFDA Acceptance Notice (No. CXHL1400799X) for its application to conduct the Phase II trial, which aims to assess the safety and efficacy of RGN-259.

"Keratoconjunctivitis sicca," commonly known as dry eye syndrome, affects a great number of people in China and can lead to severe consequences such as cornea damage and ocular inflammation. There is clearly an unmet medical need in this area. RegeneRx demonstrated in its Phase II study that RGN-259 is a promising agent in alleviating dry eye syndrome by addressing the underlying pathology with a unique mechanism of action.

"We're pleased with the acceptance of review by the CFDA for this important application," said Dr. Benjamin Li, CEO of Lee's. "The successful submission of Tβ4 highlights Lee's research & development capability in developing its product pipeline focused on ophthalmic therapeutic area. We are looking forward to moving the registration process forward and expect to initiate the clinical trial in China in Q1 2015."

"We're very pleased that the Chinese FDA has accepted Lee's IND for a Phase 2 dry eye study. Showing strong safety and efficacy results in China will not only be important to future commercialization in that country, but also validate our results in the U.S. and extend the opportunities for this product throughout the world," stated J.J. Finkelstein, RegeneRx's president & CEO.