Can-Fite sees longer survival in blinded Phase III liver cancer study, may move up interim look

Can-Fite BioPharma Ltd. announced on September 2, 2026 that overall survival across the full, blinded patient population in its Phase III trial of Namodenoson in advanced hepatocellular carcinoma has come in longer than the assumptions built into the study's original design anticipated.¹

The trial is a randomized, double-blind, placebo-controlled study testing Namodenoson in advanced HCC patients who also have Child-Pugh B7 cirrhosis, with patients assigned 2:1 to drug or placebo and overall survival as the primary endpoint.¹ The company cautioned that the survival data reflect the pooled, blinded population combining both treatment and placebo patients, so no conclusions about efficacy or differences between arms can be drawn at this stage.¹

Because of the survival trend, Can-Fite is now evaluating moving up the timing of the study's planned interim analysis, which would allow an independent look at overall survival between the Namodenoson and placebo groups under the trial's statistical analysis plan and applicable regulatory rules.¹

CEO and CFO Motti Farbstein said the company is encouraged by the survival trend, while noting the study remains blinded and the observations do not predict treatment effect, adding that an earlier interim analysis could offer useful information on Namodenoson's potential benefit in this patient population.¹

Namodenoson is described as an orally available small molecule that binds selectively to the A3 adenosine receptor.¹ Beyond the ongoing Phase III HCC trial, the compound has completed a Phase 2a study in pancreatic cancer and is currently enrolling patients in a Phase 2b trial for MASH.¹ The drug has also received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second-line HCC treatment from the FDA.¹