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

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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.
 

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