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Can-Fite BioPharma's Namodenoson Improves Liver Function, Long Term Data Shows

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  • Can-Fite BioPharma (NYSE: CANFreports new data from Phase 2 trial evaluating namodenoson in advanced liver cancer, including the overall survival of nearly four years in two patients under treatment.

  • Additional findings show the disappearance of ascites (abnormal buildup of fluid in the abdomen), normal liver function, and good quality of life.

  • In one patient, stable disease was recorded with the disappearance of peritoneal carcinomatosis (late-stage manifestation of several gastrointestinal malignancies).

  • Namodenoson continues to demonstrate a favorable safety profile and is well tolerated with no severe adverse events reported.

  • The company concluded End-of-Phase 2 meetings with the FDA and European Medicines Agency. Both agencies agreed with Can-Fite's proposed pivotal Phase 3 trial design of Namodenoson to treat patients with advanced hepatocellular carcinoma (HCC), with underlying Child-Pugh B7 cirrhosis. 

  • The company can conduct one pivotal trial with 450 subjects for registration in both the U.S. and European markets.

  • Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel.

  • Price Action: CANF gained 31.9% at $3.10 in premarket trading on the last check Monday.

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