On November 18, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete response to treatment.
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The patient, who suffered from advanced liver cancer, was enrolled in Can-Fite’s completed Phase II study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappearance of ascites, normal liver function, and good quality of life.
Can-Fite is currently enrolling patients in Israel, Europe, and the U.S. for a pivotal Phase III clinical study of Namodenoson for patients with advanced hepatocellular carcinoma (HCC), the common form of liver cancer, as a 2nd or 3rd line treatment. The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.
"With Namodenoson’s potent anti-cancer activity, along with its excellent tolerability, we aim to deliver longer survival for patients and hope to see outcomes that mirror the exceptional 9 year response achieved by the long-treated patient from our prior Phase II study. Namodenoson’s highly selective action against tumor cells, combined with its protection of healthy liver tissue, has the potential to make our Phase III trial especially promising," stated Prof. Pnina Fishman, Can-Fite CSO & Chairperson.
According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.
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.
(Press release, Can-Fite BioPharma, NOV 18, 2025, View Source [SID1234660050])