A pivotal Phase III trial for advanced liver cancer, approved by FDA & EMA and a MASH Phase IIb are enrolling patients

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that Biomedicines published an article titled “Namodenoson at the Crossroad of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Hepatocellular Carcinoma (HCC)”. Biomedicines is a highly reputable journal that publishes articles on clinical and basic science topics in medicine. https://www.mdpi.com/2227-9059/12/4/848.

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Namodenoson mechanism of action (Graphic: Business Wire)

The article’s first author, Dr. Ohad Etzion, is a renowned key opinion leader (KOL) in the Hepatology field and is the engine for some of the novel drugs under development for the treatment of MASH and additional liver diseases. Dr. Etzion is the Head, Department of Gastroenterology and Liver Diseases, at Soroka University Medical Center, Beer Sheva, Israel.

The Biomedicines article presents the pre-clinical and clinical activity of Namodenoson and the mechanism of action through which the drug induces the anti-cancer activity and at the same time the liver protective effects. This dual activity enables the drug to have positive effects in both liver cancer and MASH.

Currently, Namodenoson is being evaluated in Liveration^TM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH.

“We are very much encouraged by the clinical data from the Phase II study in HCC and the Phase IIa study in MASH. The drug mechanism of action which is presented in the manuscript and entails inflammatory cytokine inhibition together with the stimulation of positive cytokines, position Namodenoson as a promising safe drug,” stated Dr. Etzion.

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.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment metabolic dysfunction-associated steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.

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