Ramat Gan, Israel, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced a significant new clinical finding under its compassionate use program in decompensated liver cirrhosis.  The patient, previously reported by Can-Fite to have experienced the disappearance of end-stage liver disease complications while receiving Namodenoson, has now demonstrated a complete resolution of esophageal varices, as confirmed by endoscopic evaluation.

Esophageal varices are a common and severe complication of advanced liver disease, associated with a high risk of life-threatening gastrointestinal bleeding. Their resolution in a patient with decompensated cirrhosis is an uncommon clinical outcome and may suggest a disease-modifying effect of Namodenoson.

“This case highlights the potential of Namodenoson to address life-threatening complications of advanced liver disease,” stated Prof. Ohad Etzion, Chief of Gastroenterology and Liver Diseases at Soroka Medical Center in Israel. “We are encouraged by these findings, which may provide important insights for Namodenoson’s ongoing clinical development.”

Endoscopic images of the patient’s esophagus before and after Namodenoson treatment (see below) demonstrate the disappearance of varices under compassionate use therapy.


Namodenoson is currently being evaluated in a Phase III clinical trial for the treatment of hepatocellular carcinoma (HCC) in patients with advanced liver disease (Child-Pugh B). Data from compassionate use cases may provide valuable supplementary evidence regarding its broader therapeutic potential.

In 2017, an estimated 10.6 million people globally were affected by decompensated cirrhosis, and the available treatment options remain scarce, especially for patients who have reached the advanced stages of the disease. Highlighting the urgent need for new therapies, the American Liver Foundation has stated that there are more patients in need of a liver transplant than available organs, with some patients waiting over five years for a transplant. The U.S. market for liver cirrhosis treatment is projected to grow to approximately $15 billion by 2030.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that 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 reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.com/ .

Forward-Looking Statements

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Contact

Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114