Can-Fite BioPharma (CANF) New Positive Data from its Liver Cancer Phase II Clinical Study with Namodenoson
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Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced new data from the Phase II advanced liver cancer study including overall survival of nearly 4 years in two patients who are under namodenoson treatment. Additional findings show disappearance of ascites, normal liver function and good quality of life. In one patient stable disease has been recorded with disappearance of peritoneal carcinomatosis. Namodenoson continues to demonstrate a good safety profile and is well tolerated with no severe adverse events reported.
Recently, the Company successfully concluded End-of-Phase II meetings with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Both agencies agreed with Can-Fite’s proposed pivotal Phase III trial design of Namodenoson for the treatment of patients with advanced hepatocellular carcinoma (HCC), with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. The trial is expected to enroll 450 patients through multiple centers worldwide. 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.
“We are very pleased to see prolonged survival, good quality of life, and in particular clearance of peritoneal carcinomas in these two patients. The FDA and EMA gave a green light to one pivotal Phase III study which, upon positive conclusion, would lead to registration of Namodenoson for the treatment of this devastating disease. To our knowledge, Can-Fite is the only company developing a drug for this advanced patient population defined as Child Pugh B7 (CPB7) cirrhosis,” stated Can-Fite CEO Dr. Pnina Fishman.
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
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