Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

RegeneRx Biopharmaceuticals, Inc.Dec 23 2010

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex: RGN) ("the Company" or "RegeneRx") announced today that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease. The double-blind, placebo-controlled, investigator-sponsored trial is expected to enroll a total of 20 patients over the next several months, with data reported later in 2011. RGN-259 is a sterile, preservative-free topical eye drop formulation of the novel therapeutic peptide Thymosin beta 4, or Tβ4.

The clinical trial is being conducted under a physician-sponsored IND in Detroit, Michigan. Steven Dunn, M.D., the principal investigator in this study, is an ophthalmologist and corneal specialist who previously treated a group of patients with recalcitrant neurotrophic keratitis with RGN-259. In a group of six such patients, Dr. Dunn reported substantial healing within the treatment period or follow-up. His results have been published in the Archives of Ophthalmology and the Annals of the New York Academy of Sciences. Gabriel Sosne, M.D., Associate Professor of Ophthalmology at Wayne State University School of Medicine, a member of RegeneRx's Scientific Advisory Board, has spent a number of years conducting research with Tβ4 and is an investigator in the trial.

"The first patient is an important milestone in the use of RGN-259 for the treatment of dry eye. Drs. Dunn and Sosne have played critical roles in developing RGN-259 for a number of potentially significant ophthalmic indications, and we are optimistic that their work in this study will continue the significant progress seen over the past few years. A successful Phase 2 dry eye trial, in addition to the positive dry eye animal study announced early last month, would be strong evidence of RGN-259's capabilities for the treatment of dry eye and other ophthalmic conditions," stated J.J. Finkelstein, president and CEO of RegeneRx Biopharmaceuticals.