CF101: Phase III data
Top-line data from a double-blind Phase III trial in 237 patients with moderate to severe dry eye syndrome showed that twice-daily oral CF101 missed the primary endpoint of complete clearing of corneal staining at week 24 vs. placebo. OphthaliX also said CF101 missed the secondary endpoints vs. placebo, but could not be reached for details. CF101 was well tolerated. Patients received placebo or twice-daily 0.1 or 1 mg CF101 for 24 weeks. OphthaliX, which made the announcement on Dec. 30, 2013, said it will conduct a retrospective analysis of the Phase III data to determine if there is a correlation between expression levels of ADORA3 and response to CF101. The company said its decision to conduct the analysis is based on positive data reported by partner Can-Fite on Dec. 23, 2013, from a Phase IIb trial of CF101 in rheumatoid arthritis (RA) patients with elevated baseline expression levels of ADORA3 in peripheral blood mononuclear cells (PBMCs). OphthaliX did not disclose when it expects to complete the retrospective analysis. ...