New namodenoson trial data ‘positive’ for drug’s use in pancreatic cancer
Nearly one-third of patients saw their hard-to-treat cancer stabilize
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Almost a third of people with advanced pancreatic cancer taking part in an ongoing clinical trial had stable disease following treatment with the experimental oral medication namodenoson, new data show.
Can-Fite Biopharma, the Israeli biopharmaceutical developing namodenoson and sponsoring the Phase 2 trial (NCT06387342), said it expects to have top-line results in the coming months. Full results are expected to include measures such as overall survival time and time to disease progression in namodenoson-treated patients.
But early data are “promising,” and “demonstrate preliminary evidence of clinical activity … in [this] heavily pretreated patient population,” Can-Fite said in a company press release announcing key findings.
“As we continue to analyse the data, we are encouraged by the emerging signal of durable disease stabilization observed in this study,” said Pnina Fishman, chairperson and chief scientific officer of Can-Fite.
The small study enrolled a total of 20 adults with pancreatic cancer that was resistant to available therapies and/or had metastasized, meaning it had spread to other parts of the body.
All participants in the ongoing trial are given namodenoson at a dose of 25 mg twice daily, with the main goals of evaluating the therapy’s safety and its effect on patient functioning.
1 patient in small study still on namodenoson after 16 months
According to Can-Fite, available data show that more than 30% of patients in the study had stable disease, with a favorable safety and tolerability profile. The company did not provide further details on these outcomes, but it noted that 35% of patients in the study are still on treatment.
One participant has been on namodenoson for more than 16 months, per Can-Fite.
“Importantly, a meaningful proportion of patients remain on therapy for extended periods, supporting the continued clinical development of namodenoson in pancreatic cancer,” Fishman said.
Namodenoson works by activating a cellular receptor protein known as the A3 adenosine receptor, or A3AR. In certain cancer cells, activating this receptor can trigger a cascade of molecular events that ultimately leads to programmed cell death, known as apoptosis. The developer noted that namodenoson has shown particularly strong anticancer activity in pancreatic and liver cancer.
In addition to the Phase 2 study in pancreatic cancer, Can-Fite is running a Phase 3 clinical trial (NCT05201404), dubbed LIVERATION, that’s testing namodenoson against a placebo in certain patients with advanced liver cancers. Can-Fite is also developing namodenoson as a potential treatment for MASH, fully known as metabolic dysfunction-associated steatohepatitis. MASH is a liver disease in which fat builds up abnormally in the organr and triggers liver inflammation and scarring. A Phase 2 study (NCT04697810) of namodenoson in MASH is also ongoing.
