Can Fite BioPharma Ltd (CANF)

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

https://finance.yahoo.com/news/fite-starts-preclinical-studies-required-151839953.html

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.