Can-Fite BioPharma: US Medical Centers Approach FDA For Compassionate Use Approval To Treat Patients With Pancreatic Carcinoma With Oncological Drug Namodenoson

Ramat Gan, Israel, April 17, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson.

Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.

Simultaneously, Can-Fite is actively enrolling patients in Israel for a Phase IIa study—an open-label trial designed for individuals with advanced pancreatic adenocarcinoma whose disease has progressed despite at least first-line therapy. The trial aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this challenging patient population. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option.