Can-Fite BioPharma Ltd. announced that its anticipated clinical milestones for calendar year 2016. In the first quarter of 2016, Can-Fite plans to file its Phase III protocol with the European Medicines Agency (EMA) for CF101 in the treatment of rheumatoid arthritis. Initiation of patient enrollment is anticipated in the second or third quarter of 2016.

Can-Fite recently filed a trial protocol with the institutional review board (IRB) of Barzilai Medical Center in Israel, one of the planned clinical sites for the international trial to be conducted in Israel, Europe, Canada and the U.S. The Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional drugs. The study will have three arms, a 1 mg CF101 dose, a 2 mg CF101 dose, and placebo, given orally twice daily in the form of tablets. Approximately 456 patients are expected to be enrolled in the study.