Tβ4 therapy for ocular disorders closer to reality

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (www.regenerx.com) announced today that Tβ4, a synthetic version of a naturally occurring peptide that is the basis for the company's product candidates, will be the subject of three poster presentations at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) to be held in Fort Lauderdale, Florida from May 2-6, 2010. The presentations will review results of research performed using Tβ4 in the field of ophthalmology and will describe potential uses of Tβ4, including for the first time, as a drug embedded in a bandage contact lens.

“A Randomized, Double-Mask, Placebo-Controlled, Dose-Response, Phase 2 Study of the Safety and Efficacy of Thymosin beta 4 in the Treatment of Diabetic Patients' Corneal Wounds Resulting from Epithelial Debridement During Vitrectomy”

In the first presentation, "Developing a Bandage Contact Lens Delivery System for Controlled Release of Thymosin Beta 4 to the Corneal Epithelium," Dr. Gabriel Sosne and his research team at Wayne State University School of Medicine in Detroit, Michigan will describe research performed to evaluate the potential for extended release of Tβ4 for more than 100 hours. The researchers concluded that a bandage contact lens delivery system would be a novel, feasible and potentially useful way to promote direct application and extended release of Tβ4 to the surface of the eye. Dr. Sosne is Associate Professor of Ophthalmology at Wayne State University School of Medicine, Department of Ophthalmology and Anatomy/Cell Biology in Detroit, Michigan. He is also a member of RegeneRx's scientific advisory board.

The second presentation, "Antioxidative Effect of Thymosin Beta 4 for Porcine Trabecular Meshwork," will discuss results of research that was designed to evaluate the antioxidative effect of administering Tβ4 to trabecular meshwork cells in a pig model. These cells make up tissue inside the anterior (front) part of the eye that is responsible for draining most of the fluid from the eye. The degree of fluid drainage and oxidative stress may be associated with increased intraocular pressure and glaucoma, which can injure the optic nerve. The researchers in this study determined that extracellular Tβ4 has an antioxidative effect for hydrogen peroxide in the porcine trabecular meshwork cells. These findings may be relevant to reducing oxidative stress in these cells, which could potentially reduce the damage to the eye from glaucoma. The research was conducted at the departments of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine in Kyoto, Japan and Kumamoto University Graduate School of Medicine in Kumamoto, Japan.

A third presentation, "A Randomized, Double-Mask, Placebo-Controlled, Dose-Response, Phase 2 Study of the Safety and Efficacy of Thymosin beta 4 in the Treatment of Diabetic Patients' Corneal Wounds Resulting from Epithelial Debridement During Vitrectomy," will report on the clinical results from the company's Phase 2 clinical trial of its product candidate RGN-259 in patients with corneal wounds. The particular patients for whom results will be reviewed were those patients who received either the lowest dose of Tβ4 or placebo in the trial. The study was closed by RegeneRx after enrollment of the low-dose cohort due to slow patient accrual, in addition to emerging proof-of-concept data generated in compassionate-use clinical trials in patients with non-healing eye ulcers. As previously reported, the research team observed no serious adverse events following administration of RGN-259 and no statistical differences in the time to wound healing when comparing Tβ4 to placebo. The researchers did note that there appeared to be increased thickening of the corneal epithelium and reduced inflammation (cell and flare) seen in Tβ4-treated patients. These observations would be indicative of corneal re-epithelialization and wound healing and are consistent with known cell migratory and anti-inflammatory properties of Tβ4. The principal investigator of the study was Dr. Benni H. Jeng, Chief, Department of Ophthalmology at the San Francisco General Hospital and Associate Professor and Co-Director, Cornea Service, University of California San Francisco Department of Ophthalmology and Francis I. Proctor Foundation.

"Taken together, the rapidly progressing research advancements in the eye with Tβ4 are bringing the goal of making Tβ4 a novel therapy for a number of ocular disorders closer to reality," commented Dr. Sosne.