Can-Fite BioPharma Ltd. has received Institutional Review Board (IRB) approval from Rabin Medical Center to proceed with a Phase IIa clinical trial evaluating Namodenoson in patients with advanced pancreatic adenocarcinoma. The approved protocol has been submitted to Israel's Ministry of Health for final regulatory clearance.
The open-label study, designated CF102-222PC and registered as NCT06387342, will assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. According to Can-Fite's Medical Director Dr. Michael Silverman, the decision to initiate this trial was encouraged by positive preclinical data in pancreatic carcinoma experimental models and promising results from a Phase II advanced liver cancer study, where one patient demonstrated overall survival exceeding 7 years.
Trial Design and Patient Population
The multicenter open-label trial will enroll approximately 20 evaluable patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy or who refuse standard treatment. All participants will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles, with regular safety evaluations throughout the study period.
The primary objective focuses on characterizing Namodenoson's safety profile, while secondary objectives include evaluating clinical activity through multiple endpoints: Objective Response Rate using RECIST 1.1 criteria, Progression-Free Survival, Disease Control Rate, Duration of Response, and Overall Survival. The study will also assess the drug's pharmacokinetics in this patient population.
Dr. Salomon Stemmer, a leading oncology expert at the Institute of Oncology, Rabin Medical Center, will conduct the trial.
Preclinical Evidence and Mechanism of Action
Namodenoson has garnered peer-reviewed recognition for its efficacy findings in pancreatic cancer. The American Association of Cancer Research accepted Can-Fite's study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" for poster presentation at the AACR Special Conference on Pancreatic Cancer.
Additionally, the scientific journal Biomolecules published research demonstrating that "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways," providing mechanistic insight into the drug's anticancer activity.
Drug Profile and Safety Experience
Namodenoson is a small, orally bioavailable molecule that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). The drug's therapeutic potential stems from the differential expression of A3AR, which is highly expressed in diseased cells while showing low expression in normal cells. This selective targeting accounts for Namodenoson's excellent safety profile.
The compound has been evaluated in Phase II trials for hepatocellular carcinoma as a second-line treatment and for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Can-Fite's clinical experience encompasses over 1,600 patients across various studies, establishing a robust safety database.
Broader Clinical Development Program
Beyond pancreatic cancer, Namodenoson is advancing through multiple clinical programs. The drug is currently being evaluated in a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH) and a Phase III pivotal trial for hepatocellular carcinoma. The compound has received Orphan Drug Designation in both the United States and Europe, along with Fast Track Designation from the FDA as a second-line treatment for hepatocellular carcinoma.
In the previous Phase II liver cancer study, Namodenoson demonstrated the ability to prolong survival while maintaining good quality of life. Notably, two patients experienced clearance of peritoneal carcinomas, and one patient achieved a complete response lasting more than 7 years.
The drug has also shown proof-of-concept potential for treating other malignancies, including colon, prostate, and melanoma cancers, suggesting broader therapeutic applications beyond the current clinical focus areas.
