Can-Fite BioPharma Ltd. has announced the dosing of the first patient in its Phase IIa clinical trial (NCT06387342) evaluating Namodenoson in patients with advanced pancreatic adenocarcinoma. This multicenter, open-label trial aims to assess the safety, clinical activity, and pharmacokinetics of Namodenoson in patients whose disease has progressed following at least one prior line of therapy. The trial is being conducted at the Institute of Oncology, Rabin Medical Center in Israel, and at UT Southwestern Medical Center in the US.
Trial Design and Objectives
The Phase IIa study involves approximately 20 evaluable patients with advanced pancreatic adenocarcinoma. Participants will receive oral Namodenoson at a dose of 25 mg twice daily in consecutive 28-day cycles. The primary objective of the trial is to characterize the safety profile of Namodenoson. Secondary objectives include evaluating the clinical activity of the drug, as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).
Namodenoson: Mechanism of Action and Prior Studies
Namodenoson is a small, orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR). The drug has been previously evaluated in Phase II trials for hepatocellular carcinoma (HCC) and non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). According to Can-Fite, A3AR is highly expressed in diseased cells, while normal cells exhibit low expression, contributing to the drug's favorable safety profile.
Expert Commentary
Dr. Michael Silverman, Can-Fite’s Medical Officer, stated, “We are excited to have the first patient enrolled and hope that we will be able to demonstrate the safety and efficacy of Namodenoson in the pancreatic cancer patient population. This trial provides us the opportunity to explore our innovative treatment approach for patients who are facing significant gaps in effective treatment options.”
Regulatory Status
Namodenoson has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
