Can-Fite's Phase IIa Study of Namodenoson for Pancreatic Cancer Approved by Israeli Health Ministry

Can-Fite BioPharma Ltd., a biotechnology company specializing in small molecule drugs for oncological and inflammatory diseases, has announced it has received approval from the Israeli Ministry of Health to conduct a Phase IIa clinical trial. This trial will assess the efficacy and safety of orally-administered Namodenoson in treating pancreatic carcinoma.

Dr. Fishman, Can-Fite's Chief Scientific Officer and Executive Chairman, expressed optimism about the pre-clinical data, which demonstrated Namodenoson's significant anti-cancer effects and clear molecular mechanism against pancreatic carcinoma. He highlighted the importance of initiating this study for pancreatic cancer, a particularly challenging disease, and expressed hope that the drug would show similar efficacy and safety in this patient group as it did in advanced liver cancer patients.

The Phase IIa trial is a multicenter, open-label study targeting patients with advanced pancreatic adenocarcinoma who have seen disease progression despite first-line therapy. The trial aims to evaluate the safety, clinical activity, and pharmacokinetics of Namodenoson. Participants will receive 25 mg of Namodenoson orally twice daily in 28-day cycles, with regular assessments for safety. Approximately 20 patients will be enrolled.

The primary aim of the trial is to determine Namodenoson's safety profile, while secondary objectives include evaluating its clinical activity based on various criteria such as 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. Stemmer at the Institute of Oncology, Rabin Medical Center in Israel, and Dr. Al Mutar from UT Southwestern Medical Center in the United States.

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

Can-Fite BioPharma Ltd. is an advanced clinical-stage drug development company targeting significant markets in cancer, liver, and inflammatory diseases. Piclidenoson, the company's leading drug candidate, recently showed positive results in a Phase III trial for psoriasis. Namodenoson is currently undergoing Phase IIb trials for NASH, a Phase III trial for hepatocellular carcinoma, and is set for a Phase IIa study in pancreatic cancer. The drug has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for second-line treatment of hepatocellular carcinoma by the U.S. FDA. Namodenoson has also shown potential in treating other cancers like colon, prostate, and melanoma.

Can-Fite's third drug candidate, CF602, has demonstrated efficacy in treating erectile dysfunction. These drugs have been tested in over 1,600 patients in clinical studies, showing excellent safety profiles.