RegeneRx's RGN-259 Meets Key Efficacy Objectives in Phase 2 Clinical Trial in Patients with Severe Dry Eye Reported in Current Issue of Cornea
PR Newswire

ROCKVILLE, Md., April 1, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx") today announced that a new medical paper has been published describing the positive effects of Thymosin beta 4 (TB4) in patients with severe dry eye.  The results met key efficacy objectives of the study and the physicians stated that statistically significant differences in both signs and symptoms of severe dry eye were seen at various time points throughout the study.  Of particular note at day 56, the RGN-259-treated group had 35.1% reduction of ocular discomfort compared with vehicle control (P=0.0141), and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108).  Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production.

The physician-initiated, phase 2, randomized, placebo controlled study was published in Cornea, 2015 May;34(5):491-496 and conducted by Drs. Gabriel Sosne and Stephen Dunn at the Kresge Eye Institute, Wayne State University and Michigan Cornea Consultants in Detroit, Michigan, and Chaesik Kim, the biostatistician for the study, who is also affiliated with the Kresge Eye Institute and Wayne State University.  Dr. Sosne serves on RegeneRx's scientific advisory board and RegeneRx contributed RGN-259 and placebo for the study and provided limited financial support.

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 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 Tβ4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK).  RegeneRx was recently allowed by the FDA to move into Phase III clinical trials with RGN-259 for the treatment of patients with NK.  The drug candidate is also being studied in patients with dry eye syndrome in the U.S. and Asia.  RegeneRx, through its U.S. joint venture, ReGenTree LLC, will be developing RGN-259 in the United States.  RGN-352, the Company's Tβ4-based injectable, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar traumatic injuries.  For additional information about RegeneRx please visit

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SOURCE RegeneRx Biopharmaceuticals, Inc.