April 13, 2011
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") today announced positive new data related to RGN-259, its preservative-free ophthalmic drug candidate. In a second "dry eye" study conducted by Ora, Inc. using their Preclinical CAE? Murine (mouse) Model, four active concentrations of RGN-259 were compared to three control groups, consisting of a negative control (vehicle) and two positive controls (doxycycline and Restasis?). The animals were treated for a total period of nine days following the inducement of moderate, and then severe, dry eye. In the moderate dry eye phase of the study, after six days of treatment, two concentrations of RGN-259 showed a statistically significant reduction in corneal fluorescein staining, a method used to determine the extent of damage to the cornea, which returned to near baseline (normal) levels. After inducement of severe dry eye in the same mice, treatment with RGN-259 for three additional days similarly showed a greater reduction of corneal staining compared to the control groups, although no group achieved statistical significance. This study confirms and expands upon a previous study that also showed a statistically significant reduction of corneal staining back to near baseline levels in a similar animal model. Data from both studies will be presented at the 2011 Association for Research in Vision and Ophthalmology (ARVO) meeting in Ft. Lauderdale on May 3.
"Two different concentrations of RGN-259 were observed to be superior to the positive controls and reduced staining essentially to baseline levels in the standard murine dry eye model. The mechanism of action of wound healing and anti-inflammatory properties of T?4, together with the preclinical data from this and the prior animal study indicate a substantial therapeutic potential in dry eye," stated George Ousler III, vice-president of dry eye at Ora, Inc., Andover, MA.
"The results of this latest animal study will have a significant impact on our clinical program and how we view the path toward development of RGN-259. We believe the two dry eye animal studies, along with previous positive results in humans that showed the ability of RGN-259 to repair non-healing corneal ulcers, with no observed adverse safety events, provide a solid foundation to support commercial development. We have already begun planning a Phase 2 clinical trial focused on developing RGN-259 for the treatment of dry eye," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.