Benzinga | Feb 22, 2021 08:21AM EST

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

* Can-Fite BioPharma (NYSE: CANF) reports 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.