Namodenoson (CF102)
- Indication
- Advanced liver cancer, hepatocellular carcinoma
- Stage
- phase3
- Event
- Interim Data
- Details
Sept. 2, 2026: Can-Fite BioPharma Ltd. (NYSE: CANF; TASE: CANF) said it plans to advance the interim analysis of its ongoing pivotal Phase III trial of Namodenoson in advanced hepatocellular carcinoma (HCC) in patients with underlying Child-Pugh B7 cirrhosis. The randomized, double-blind, placebo-controlled study assigns patients 2:1 to Namodenoson or placebo, with overall survival as the primary endpoint.
The company said blinded overall survival across the pooled study population appears longer than originally anticipated based on the trial design assumptions. Because the study remains blinded and includes both treatment and placebo patients, the company said no conclusions can yet be drawn about Namodenoson’s efficacy or differences between arms.
Can-Fite said an earlier interim analysis would allow an independent assessment of overall survival between Namodenoson and placebo under the statistical analysis plan and regulatory requirements.
Program update: Namodenoson is also described as having completed a Phase 2a study in pancreatic cancer and currently enrolling patients in a Phase 2b trial in metabolic dysfunction-associated steatohepatitis (MASH). The release also says Namodenoson has U.S. and European orphan drug designation and FDA Fast Track designation as a second-line treatment for HCC.
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