RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") announced today that it has received the clinical study report for its recently completed Phase 2 clinical trial evaluating RGN-259 for the treatment of dry eye syndrome. The following conclusions were highlighted in the report's summary:
"The efficacy of RGN-259 for the topical treatment of the primary signs and symptoms of dry eye was proven with this study by its protective effects to adverse stimuli as well as its enhanced repair at 24-hour recovery after CAE [controlled adverse environment] challenge." "RGN-259 was shown to be safe and very well tolerated." "In this exploratory study with only 35 subjects per group, RGN-259 was shown to have clinically significant effects on dry eye, albeit not in the chosen pre-determined primary endpoints." "The significant protective effect that RGN-259 was shown to have on ocular discomfort and corneal staining in response to adverse stimuli indicate that changes in response to the CAE challenge are effective new endpoints for future clinical trials." "The ability of RGN-259 after one month of treatment to protect the eye from adverse stimuli has obvious clinical significance in the treatment of dry eye. Acceleration in wound repair is the probable mechanism of action behind the significant 24-hour recovery from damage ensued during CAE challenge with regard to central fluorescein corneal staining." "Protection from adverse stimuli, indicated by the dampening of response from baseline to CAE challenge after 28 days of treatment, was also proven in this pilot study. RGN-259 caused significant lowering of scores in ocular discomfort and superior and peripheral corneal staining compared to placebo treatment. These exciting findings have newly defined important primary endpoints for future studies."
"We are pleased the study report confirmed preliminary findings that RGN-259 was safe, well tolerated, and had a clinically relevant and statistically significant effect on the treatment of the primary signs and symptoms of dry eye. In our next study with RGN-259, we intend to specifically focus on these results as we seek to move forward toward developing a novel and effective treatment for dry eye syndrome," stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.