FDA Grants Compassionate Use Treatment to Namodenoson in Pancreatic Cancer

FDA grants approval to an act of compassionate use treatment with Namodenoson for a patient with pancreatic cancer: © Tada Image - stock.adobe.com.

The Food and Drug Administration (FDA) has granted approval to an act of compassionate use treatment with the anti-cancer drug Namodenoson for a patient based in the United States with pancreatic cancer, according to a news release from Can-Fite BioPharma Ltd., an advanced clinical stage drug development Company.

Compassionate use, according to the official FDA website, fda.gov, allows a doctor or physician to request access to an experimental drug outside of clinical trials for a patient with a serious or immediately life-threatening disease or condition when no comparable or satisfactory alternative therapy options are available. As such, Namodenoson has not yet been approved by the FDA but may offer potential benefits when no other treatments are available, the news release states.

“We are pleased to offer this compassionate use program with Namodenoson for [an] eligible patient in the United States to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, concurrently to our ongoing phase 2a clinical trial, as we remain committed to advancing the availability of our drug,” Pnina Fishman, chairperson of Can-Fite BioPharma, explained in the news release.

More Information on the Investigation of Namodenoson

Namodenoson is an oral drug being investigated for its potential to treat advanced liver cancer, pancreatic cancer and metabolic dysfunction-associated steatohepatitis. The investigational agent works by targeting the A3 adenosine receptor, a specific receptor which is highly present in diseased cells but has low expression in healthy cells. This selective targeting may contribute to the drug’s favorable safety profile. 

Notably, the drug is currently being tested in several clinical trials. The pivotal phase 3 LiverationTM study is evaluating Namodenoson in advanced liver cancer and has been approved by both the FDA and the European Medicines Agency for this patient group. Additionally, a phase 2a trial is underway in Israel to assess its potential in pancreatic cancer, and a phase 2b trial is exploring its effectiveness in metabolic dysfunction-associated steatohepatitis. 

The FDA has granted Namodenoson orphan drug designation for pancreatic cancer. The orphan drug designation is a status granted by the FDA to drugs and biologics intended to treat rare diseases or conditions, according to the FDA website, which noted that the regulatory designation is a separate process from seeking approval or licensing.

According to the press release from the company which announced the agent’s orphan drug designation status in October 2024, a clinical trial is underway to evaluate Namodenoson in patients with advanced pancreatic cancer. This study will be conducted at multiple medical centers and will include approximately 20 patients whose cancer has progressed despite receiving at least one prior treatment. 

The primary goal of the trial is to assess the safety of Namodenoson, ensuring that it does not cause significant side effects. In addition to safety, researchers will evaluate how effective the drug is in controlling the disease. Investigators will assess tumor shrinkage, how long patient disease remain stable without their cancer worsening and overall survival. Another important aspect of the trial is studying how Namodenoson is processed by the body, known as pharmacokinetics.

All participants in the trial will receive Namodenoson at a dose of 25 milligrams twice daily in repeating 28-day cycles. Throughout the study, patients will be closely monitored to ensure safety and track any changes in their condition.

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