RegeneRx joint venture retains Ora to carry out RGN-259/GBT201 clinical trials in U.S.

RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx") today announced its U.S. joint venture with G-treeBNT (ReGenTree LLC) has retained Ora, Inc. to conduct a phase 3 clinical trial for the orphan disorder, neurotrophic keratopathy (NK), and a 2b/3 dose-response, confirmatory trial for dry eye syndrome (DES) in the U.S. Both trials will be testing ReGenTree's preservative-free eye drops, RGN-259/GBT201, this year. Each of these eye disorders was being targeted by RegeneRx prior to entering into the joint venture.

Earlier clinical trials with RGN-259 (thymosin beta 4 ophthalmic solution) have demonstrated the drug candidate's ability to significantly improve both signs and symptoms of DES and identified co-primary endpoints to be targeted in the DES trials. Results of a small physician-sponsored phase 2 clinical trial in patients with severe dry eye were recently published in Cornea (2015 May;34(5):491-496) demonstrating statistically significant improvements in patients' signs and symptoms. Positive results with RGN-259 have also been seen in patients with chronic neurotrophic keratopathy, a degenerative disease of the corneal epithelium resulting from impaired corneal innervation that may cause ulceration and perforation of the cornea.

Ora is a recognized leader in ophthalmic product development and has developed a Controlled Adverse Environment (CAE^®) model for dry eye allowing rapid recruitment, treatment and evaluation of patients with DES. Ora has significant experience with RGN-259 having previously conducted a 72-patient phase 2 dry eye trial with the drug candidate on behalf of RegeneRx.