FDA Greenlights Namodenoson Compassionate Use for Pancreatic Cancer Patient

On March 18, 2025, Can-Fite BioPharma Ltd., a biotechnology firm listed on both the NYSE American and TASE as CANF, announced that it secured approval from the FDA for compassionate use of its anti-cancer medication, Namodenoson, for a pancreatic cancer patient in the United States. Compassionate use refers to the process where a doctor requests permission to use an investigational drug for a patient suffering from a serious illness when the drug has not yet received FDA approval.

Pnina Fishman, the Chief Scientific Officer and Chairperson of Can-Fite, expressed satisfaction in offering Namodenoson under this compassionate use program. She highlighted the significance of this initiative as a step in meeting the medical needs of pancreatic cancer patients in the U.S. Fishman also mentioned that this milestone aligns with the ongoing Phase 2a clinical trial of Namodenoson, demonstrating the company's commitment to making the drug more widely available.

Namodenoson is currently under evaluation in LiverationTM, a pivotal Phase III clinical trial targeting advanced liver cancer. This trial has received approval from both the FDA and the European Medicines Agency (EMA). Additionally, the drug is undergoing a Phase IIa clinical study for pancreatic cancer in Israel.

In the U.S., Namodenoson has been granted Orphan Drug Designation for its potential use in treating pancreatic cancer. This designation provides several benefits, including the possibility of market exclusivity for seven years post-approval, along with other regulatory advantages. Namodenoson is a small, orally administered drug that shows high affinity and selectivity for the A3 adenosine receptor (A3AR). The drug is also being tested in a Phase III trial for advanced liver cancer, a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis (MASH), and a Phase IIa trial for pancreatic cancer. The A3AR receptor is notably expressed in diseased cells, whereas normal cells exhibit low expression. This significant difference might be a key factor contributing to Namodenoson's strong safety profile.

Can-Fite BioPharma Ltd. is a clinical-stage drug development company that focuses on treatments for cancer, liver, and inflammatory diseases, targeting multibillion-dollar markets. Among its prominent drug candidates is Piclidenoson, which has recently shared topline results from a Phase III trial for psoriasis and is anticipated to begin a pivotal Phase III trial soon. Namodenoson, Can-Fite’s lead drug for liver cancer, is being assessed in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for MASH, and a Phase IIa study for pancreatic cancer. Namodenoson holds Orphan Drug Designation in both the U.S. and Europe and has received Fast Track Designation from the U.S. FDA as a second-line treatment for HCC. The drug has shown potential in early studies to treat other cancers, such as colon, prostate, and melanoma. Another drug from Can-Fite, CF602, is in development for treating erectile dysfunction, displaying promising results so far. To date, over 1,600 patients have participated in clinical trials for these drugs, which have demonstrated an excellent safety profile.