Can-Fite Secures IRB Approval for Phase IIa Trial of Namodenoson in Pancreatic Cancer

11 June 2024

Can-Fite BioPharma Ltd., a company focused on developing proprietary small molecule drugs for cancer and inflammatory diseases, has announced that the Institutional Review Board (IRB) at Rabin Medical Center in Israel has approved its clinical study. This approval is a prerequisite before submitting the protocol to the Ministry of Health (MOH).

Can-Fite, stated, “We are conducting this Phase IIa open-label study to evaluate the safety and potential effectiveness of Namodenoson in patients with advanced pancreatic cancer whose condition has worsened following initial treatment. Our earlier findings from experimental models in pancreatic carcinoma, along with successful results from a Phase II study in advanced liver cancer showing prolonged survival, have encouraged us to proceed with this trial.”

The clinical study, named CF102-222PC, is entitled “A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma,” and is registered under Identifier: NCT06387342.

This multicenter, open-label trial will enroll patients with advanced pancreatic adenocarcinoma who have experienced disease progression after at least one line of therapy or who opt out of standard treatments. The study will assess the safety, clinical efficacy, and pharmacokinetics of Namodenoson. Participants will receive oral Namodenoson 25 mg twice daily for 28-day cycles, with regular assessments of safety. The study aims to enroll about 20 evaluable patients. The primary goal is to define the safety profile of Namodenoson, while secondary objectives include evaluating its clinical efficacy using measures such as the Objective Response Rate (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study will be led by Dr. Salomon Stemmer at the Institute of Oncology, Rabin Medical Center, Israel.

Namodenoson has recently received recognition in peer-reviewed journals for its effectiveness in treating pancreatic cancer. Can-Fite’s study on the molecule was presented at the AACR Special Conference on Pancreatic Cancer, and an article discussing its mechanisms was published in the journal Biomolecules.

Namodenoson is a small molecule that is taken orally and binds selectively to the A3 adenosine receptor (A3AR) with high affinity. It has been evaluated in Phase II trials for conditions such as second-line treatment for hepatocellular carcinoma, as well as treatments for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is mainly expressed in diseased cells, with minimal expression in healthy cells, which contributes to the drug’s favorable safety profile.