Benzinga | Apr 20, 2021 11:18AM EDT

Can-Fite Starts Preclinical Studies Required By FDA, EMA For Two Lead Drug Candidates Registration Filing

* Can-Fite BioPharma (NYSE: CANF) has initiated a series of preclinical studies required by regulators to support potential marketing registration filings for its drug candidates Piclidenoson and Namodenoson in the U.S. and Europe.

* As part of marketing applications in the U.S. and Europe, both regulators require specific preclinical data to be submitted along with the pivotal Phase 3 data.

* Piclidenoson is now being evaluated in the COMFORT Phase 3 clinical study designed to establish Piclidenoson's superiority compared to placebo and non-inferiority compared to Amgen, Inc's (NASDAQ:AMGN) Otezla (Apremilast) for moderate-to-severe plaque psoriasis.

* A Phase 3 study of Namodenoson in the treatment of hepatocellular cancer (HCC) is expected to commence in the fourth quarter of this year.

* Price Action: CANF shares are up 0.56% at $2.1 in market trading hours.