On July 30, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported that it achieved the over 50% enrollment milestone in its Phase 2a trial of Namodenoson for pancreatic cancer (Press release, Can-Fite BioPharma, JUL 30, 2025, View Source [SID1234654651]).
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The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.
"This milestone reflects the strong interest among both investigators and patients in exploring Namodenoson as a potential treatment for one of the deadliest and most aggressive cancers," stated Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. "We are encouraged by the pace of enrollment and remain committed to advancing Namodenoson as a much-needed therapeutic option for patients with pancreatic cancer."
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.