Can-Fite BioPharma Ltd. (NYSE American: CANF) has announced the first patient has been dosed in its Phase IIa clinical trial evaluating Namodenoson for the treatment of advanced pancreatic adenocarcinoma. This multicenter, open-label trial aims to assess the safety and clinical activity of Namodenoson in patients whose disease has progressed despite prior first-line treatment. The trial is currently underway at Rabin Medical Center in Israel and UT Southwestern Medical Center in the United States.
Trial Design and Objectives
The Phase IIa study will enroll approximately 20 evaluable patients who will receive Namodenoson orally at a dose of 25 mg twice daily. The primary objective of the trial is to characterize the safety profile of Namodenoson in this patient population. Secondary objectives include evaluating clinical activity through key metrics such as Objective Response Rate (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).
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.”
Namodenoson: Mechanism and Prior Studies
Namodenoson is an orally bioavailable small molecule drug that selectively binds to the A3 adenosine receptor (A3AR). Preclinical and clinical data suggest that A3AR is highly expressed in diseased cells, while showing low expression in normal cells, potentially contributing to the drug's safety profile. Namodenoson has previously been evaluated in Phase II trials for hepatocellular carcinoma (HCC) and non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Orphan Drug Designation
Notably, Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This designation provides Can-Fite with potential benefits, including tax credits for clinical trials, exemption from user fees, and potential seven-year market exclusivity upon regulatory approval.
Pancreatic Cancer: Unmet Needs
Pancreatic cancer remains a significant challenge in oncology, with a high mortality rate and limited treatment options, particularly for patients who have progressed on first-line therapy. The initiation of this Phase IIa trial represents a crucial step in exploring new therapeutic avenues for this difficult-to-treat disease.
