Can-Fite Gains IRB Approval for Namodenoson Phase IIa Pancreatic Cancer Study

Can-Fite BioPharma Ltd., a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases, has announced the approval of a new study by the Institutional Review Board (IRB) of Rabin Medical Center in Israel. The study, which is now awaiting approval from the Ministry of Health (MOH), aims to explore the safety and efficacy of Namodenoson in patients with advanced pancreatic cancer.

The clinical trial, titled "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma" and registered under ClinicalTrials.gov Identifier NCT06387342, is designed as an open-label Phase IIa study. This means that both the researchers and the participants know which treatment is being administered. The primary goal of the study is to assess the safety profile of Namodenoson, while the secondary objective is to evaluate its clinical activity. Key metrics for evaluation include the 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 Director, highlighted the encouraging pre-clinical data for Namodenoson in pancreatic cancer and previous positive outcomes in a Phase II advanced liver cancer study. These promising results have motivated the initiation of this new clinical trial.

The trial will be conducted at multiple centers and will involve approximately 20 evaluable patients. These patients will have either progressed after first-line therapy or have refused standard treatments. Participants will receive 25 mg of oral Namodenoson twice daily in 28-day cycles and will be regularly monitored for safety and efficacy.

Dr. Salomon Stemmer, a leading key opinion leader in the field, will oversee the study at the Institute of Oncology, Rabin Medical Center. The trial aims to provide critical data on the potential of Namodenoson to treat advanced pancreatic adenocarcinoma, a disease with limited treatment options.

Namodenoson has recently been recognized for its efficacy in pancreatic cancer by prominent organizations. The American Association of Cancer Research (AACR) acknowledged the drug in a study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway," which was presented at the AACR Special Conference on Pancreatic Cancer. Additionally, the journal Biomolecules published an article showcasing Namodenoson's ability to inhibit pancreatic carcinoma growth through the deregulation of multiple signaling pathways, including Wnt/β-catenin, NF-κB, and RAS.

Namodenoson is a small, orally bioavailable drug that selectively targets the A3 adenosine receptor (A3AR). This receptor is highly expressed in diseased cells but shows low expression in normal cells, contributing to the drug's excellent safety profile. Namodenoson has already been evaluated in Phase II trials for hepatocellular carcinoma and non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Can-Fite BioPharma Ltd. is a clinical-stage drug development company with a focus on treatments for cancer, liver, and inflammatory diseases. The company’s leading drug candidate, Piclidenoson, recently completed a Phase III trial for psoriasis and is set to begin another pivotal Phase III trial. Namodenoson is also being tested in Phase IIb and Phase III trials for other indications, including hepatocellular carcinoma and Metabolic Dysfunction-associated Steatohepatitis (MASH).

Overall, Can-Fite BioPharma is advancing its pipeline of proprietary small molecule drugs with the potential to address significant unmet medical needs in oncology and inflammatory diseases.