Can-Fite BioPharma announced that major U.S. medical centers are requesting FDA compassionate use approval for Namodenoson, its pancreatic cancer drug. This follows the FDA’s recent approval of Namodenoson for its first single-patient compassionate use treatment. Concurrently, Can-Fite is enrolling patients in Israel for a Phase IIa trial to evaluate Namodenoson’s safety and efficacy in advanced pancreatic adenocarcinoma.
This development is particularly important because pancreatic cancer is a notoriously difficult-to-treat disease with limited effective therapies. The increased interest from leading U.S. oncologists suggests a recognized need for new treatment options and potential confidence in Namodenoson’s preliminary clinical data. The FDA’s initial compassionate use approval, even for a single patient, provides a crucial pathway for patients who have exhausted standard treatment options. It also offers valuable real-world data that can further support future clinical development and potential broader access.
Namodenoson is an orally bioavailable drug targeting the A3 adenosine receptor, which is overexpressed in diseased cells. It is also being evaluated in a Phase III trial for advanced liver cancer and a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH). The drug has received Orphan Drug Designation in the U.S. and Europe, and Fast Track Designation for second-line treatment of HCC by the FDA.
This increased interest in Namodenoson for pancreatic cancer signifies potential momentum for Can-Fite. Positive results from the ongoing Phase IIa trial and continued compassionate use approvals could pave the way for larger clinical studies and eventual market approval, positioning Namodenoson as a valuable new therapy in the fight against this aggressive cancer. This also underscores the potential for Can-Fite’s A3 adenosine receptor-targeting platform across multiple indications.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
