On September 2, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that blinded overall survival observed across the entire patient population in its ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions underlying the study design.
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The pivotal Phase III study is a randomized, double-blind, placebo-controlled study evaluating Namodenoson in patients with advanced HCC and underlying Child-Pugh B7 cirrhosis. Patients are randomized 2:1 to receive Namodenoson or placebo, with overall survival as the primary efficacy endpoint. The observed survival reflects the pooled, blinded study population and includes patients receiving both Namodenoson and placebo. Accordingly, no conclusions regarding treatment efficacy or differences between the study arms can be drawn from these data at this stage.
In view of the longer-than-anticipated survival observed in the study population, Can-Fite is evaluating an earlier timing for the study’s planned interim analysis. The interim analysis will enable an independent assessment of overall survival between the Namodenoson and placebo treatment groups in accordance with the study’s statistical analysis plan and applicable regulatory requirements.
"We are encouraged by the longer overall survival being observed among patients participating in this pivotal study," said Motti Farbstein Can-Fite CEO & CFO. "While the study remains blinded and these observations cannot predict the treatment effect of Namodenoson, we believe that conducting the planned interim analysis earlier could provide important information regarding the potential clinical benefit of Namodenoson in this patient population with substantial unmet medical need."
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 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and is enrolling patients in a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). 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, SEP 2, 2026, View Source [SID1234670531])