Can-Fite BioPharma Ltd. has announced the dosing of the first patient in its Phase IIa clinical trial evaluating Namodenoson for the treatment of advanced pancreatic adenocarcinoma. The trial, identified as NCT06387342, is a multicenter, open-label study designed 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 Phase IIa study will enroll approximately 20 evaluable patients who will receive oral Namodenoson at a dose of 25 mg twice daily in consecutive 28-day cycles. Patients will undergo regular safety evaluations, with the primary objective being 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).
Rationale for Namodenoson in Pancreatic Cancer
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."
Pancreatic cancer remains a formidable challenge in oncology, characterized by aggressive progression and limited treatment options, especially in advanced stages. The current standard of care often involves chemotherapy regimens, but many patients experience disease progression, underscoring the need for novel therapeutic strategies.
About Namodenoson
Namodenoson is a small, orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells but shows low expression in normal cells, potentially contributing to the drug's favorable safety profile. Namodenoson has been previously evaluated in Phase II trials for hepatocellular carcinoma and non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
The study is being conducted at the Institute of Oncology, Rabin Medical Center in Israel, led by Dr. Salomon Stemmer, and at the UT Southwestern Medical Center in the US, led by Dr. Al Mutar. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Namodenoson for the treatment of pancreatic cancer.
