On January 10, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, reported that it will hold one-on-one virtual investor meetings during the J.P. Morgan Healthcare Conference (Press release, Can-Fite BioPharma, JAN 10, 2022, View Source [SID1234598517]).
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The Company recently reported a complete response to Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, in its Open Label Extension program of its concluded Phase II study. This follows publication in October 2021 of an article featuring positive Phase IIa NASH study data of Namodenoson in Alimentary Pharmacology & Therapeutics (AP&T), a peer reviewed scientific journal focused on gastroenterology and hepatology. According to AP&T, the article was the top electronic download in the month of November of articles published in AP&T.
In the first quarter of 2022, Can-Fite expects to commence patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed with the design of the 471-patient study. 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.
About Namodenoson
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.