Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced 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.

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.