• These data support namodenoson as a leading drug candidate to treat patients in an exploratory Phase II clinical study

PETACH TIKVA, Israel / Oct 30, 2023 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced that Biomolecules, a peer-reviewed scientific journal focused on function and mechanism of bioactive molecules, published an article titled “Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways”, authored by Can-Fite’s CSO Dr. Pnina Fishman and others.

The article includes a summary on the robust inhibition of pancreatic carcinoma growth, both in vitro and in vivo and a definitive description of the molecular mechanism of action. The latter includes de-regulation of three signal transduction pathways known to play a pivotal role in the etiology and pathology of the disease, including the Wnt, NF-kB and the RAS signalling pathway. As a result, death of pancreatic carcinoma cells takes place via apoptosis. This mechanism is highly important since pancreatic carcinoma cells are resistant to the chemotherapy.

The Company is developing an exploratory Phase II study protocol that is designed to allow treatment of patients with pancreatic carcinoma who failed first line therapy. The study objectives will include safety and efficacy of the Namodenoson drug.

Currently, Namodenoson is being evaluated in a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of Namodenoson against pancreatic carcinoma,” stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. “We plan to start treating patients very shortly and hope that Namodenoson, with its positive safety and efficacy profile, will prolong life for pancreatic cancer patients.”

About Namodenoson

Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase IIb trial for NASH and a pivotal Phase III for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). 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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

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