OphthaliX to Retrospectively Analyze Phase III Dry Eye Syndrome Study Data Based on A3 Adenosine Receptor Biomarker
Tuesday 31 December 2013
PETACH TIKVA, Israel, Dec. 31, 2013 /PRNewswire/ -- Can-Fite BioPharma Ltd. (TASE: CFBI), (NYSE MKT: CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today the following:
The Company's subsidiary, OphthaliX Inc. (OTCQB: OPLI), will conduct a retrospective analysis of its Phase III Dry Eye Syndrome study data to determine if there is a correlation between the A3 adenosine receptor ("A3AR") biomarker and patients' response to CF101. This analysis will be conducted as a result of recent positive data from the Phase IIb Rheumatoid Arthritis study where patients have been enrolled based on the presence of this biomarker.
In order to perform the retrospective analysis, blood samples will be collected from patients who participated in the Phase III Dry Eye Syndrome study and analyzed for the expression of the biomarker.
As previously announced, Can-Fite was recently granted a U.S. patent for the utilization of the A3AR as a biomarker to predict patients' response to CF101 in autoimmune inflammatory indications.
Can-Fite's platform technology is based on the development of small molecule orally bioavailable drugs, in particular, ligands that bind to the A3AR, which is known to be over-expressed in inflammatory cells. The correlation between A3AR expression levels prior to treatment with CF101 and patients' response to the drug suggest that the A3AR may be a predictive biomarker to be analyzed prior to CF101 treatment. As such, and based on past Phase IIa clinical data in Rheumatoid Arthritis patients suggesting a direct, statistically significant correlation, Can-Fite developed a simple blood assay to test the expression level of such a biomarker, which is the subject of the patent. Most currently, all potential patients for Can-Fite's Phase IIb clinical trial in Rheumatoid Arthritis were tested for such A3AR biomarker prior to treatment and only those with an A3AR over-expression were enrolled in the trial.
"Following the successful data from our recent Phase IIb Rheumatoid Arthritis study where the utilization of the specific biomarker has been validated, we decided to retrospectively analyze its presence in the patient population of the Phase III Dry Eye Syndrome study to better understand the potential of CF101 for this indication." stated Pnina Fishman, Chief Executive Officer of Can-Fite.
About CF101
CF101 is a small molecule orally bioavailable drug which binds with high affinity and selectivity to the A3AR, which is known to be over-expressed in inflammatory cells. The correlation between A3AR expression levels prior to treatment and patients' response to CF101 suggests that the A3AR may be utilized a predictive biomarker to be analyzed prior to patients' treatment. CF101 is currently being developed for the treatment of Rheumatoid Arthritis and other inflammatory indications, including Psoriasis, for which positive data from an interim analysis of an ongoing Phase II/III study was recently released by the Company.
