Can-Fite: CHMP Issues Positive Opinion On Piclidenoson Phase III Clinical Trial

(RTTNews) - Can-Fite BioPharma Ltd. (CANF) announced it received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency with respect to the submission of a registration plan for a Phase III clinical trial for the treatment of moderate to severe psoriasis. The company said the Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency. The company plans to initiate a prospective double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson to support a marketing authorization application.

The company recently reported topline results from its Phase III COMFORT study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson.

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