Can-Fite Phase III Fails

Can-Fite BioPharma (TASE:CFBI), (NYSE MKT:CANF) subsidiary OphthaliX Inc. (OTCBB:OPLI) released results from a 24 week, placebo-controlled phase III study involving 237 patients with moderate-to-severe Dry Eye Syndrome who were treated with its licensed drug CF101, an A3 adenosine receptor agonist. The patients were randomized to receive two oral doses of CF101 (0.1 mg or 1.0 mg) or a placebo, for a period of 24 weeks. In the study, CF101 did not meet the primary efficacy endpoint of complete clearing of corneal staining, nor the secondary efficacy endpoints. Nonetheless, CF101 was found to be well tolerated. CF101 is developed by Can-Fite for anti-inflammatory indications. Last week, Can-Fite announced positive data from a Phase II clinical trial in Rheumatoid Arthritis. In addition, Can-Fite is conducting a phase II/III clinical study in patients with Psoriasis. Can-Fite announced positive interim analysis of the Psoriasis study several months ago and patients enrollment in the second segment is ongoing in the United States, Europe and Israel. The final data from this study is expected to be released during 2014. OphthaliX is also developing CF101 for the treatment of Glaucoma and Uveitis. The interim data from the ongoing phase II study in Glaucoma is expected to be released during 2014.