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.
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