DENVER, Colo. (247marketnews.com) — Can-Fite BioPharma (NYSEAMERICAN:CANF) has put a potentially important new marker on the radar for its late-stage liver-cancer program: patients in the company’s ongoing pivotal Phase III study of Namodenoson are living longer than anticipated across the blinded study population.
The company has not reported a treatment effect, and the trial remains blinded, so investors cannot yet conclude that Namodenoson is outperforming placebo, but the longer-than-expected overall survival has prompted Can-Fite to consider moving up its planned interim analysis, turning what was previously a waiting game into a potentially much more immediate catalyst.
The study, known as LIVERATION, is a randomized, double-blind, placebo-controlled Phase III trial evaluating orally administered Namodenoson in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh B7 cirrhosis. Overall survival is the primary efficacy endpoint. ClinicalTrials.gov currently lists the trial as recruiting, with an estimated enrollment of 471 patients.
Can-Fite CEO and CFO Motti Farbstein said the company is “encouraged by the longer overall survival being observed,” while emphasizing that the study remains blinded and the observation cannot predict Namodenoson’s eventual treatment effect.
That is precisely why the next step could be more consequential than the headline itself.
An earlier interim analysis would allow an independent assessment of survival between the Namodenoson and placebo groups under the study’s statistical plan. If the difference is favorable and statistically compelling, the program could move substantially closer to a regulatory discussion. Can-Fite has previously said the program carries FDA Fast Track and U.S. and European Orphan Drug designations, and the company highlighted its established FDA/EMA regulatory framework for Namodenoson in an August filing.
The medical backdrop is significant. HCC is an aggressive cancer, and the LIVERATION population consists of patients whose disease has progressed following at least first-line therapy while also having impaired liver function. That combination makes development particularly challenging and potentially makes a meaningful survival signal especially important.
Namodenoson is designed to activate the A3 adenosine receptor (A3AR), which Can-Fite says is highly expressed in diseased cells while relatively low in normal cells. The company is also advancing Namodenoson in MASH and has been developing additional oncology applications. Earlier clinical work provided the rationale for making overall survival the centerpiece of the Phase III program.
With Can-Fite also advancing a separate Phase III psoriasis program toward an interim analysis expected in Q4 2026/Q1 2027, the company has multiple late-stage catalysts developing in parallel.
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