U.S. Centers Seek Namodenoson for Pancreatic Cancer Compassionate Use

Medical centers in the U.S. are seeking compassionate use approval from the U.S. Food and Drug Administration (FDA) for Namodenoson in the treatment of patients with pancreatic carcinoma, according to a news release from Can-Fite BioPharma Ltd.

Compassionate use, also referred to as expanded access, allows patients with serious or life-threatening conditions to receive investigational drugs, biologics or devices outside of clinical trials when no comparable or satisfactory alternatives exist, according to the FDA’s website, fda.gov.

To qualify, a patient must be affected by a medical condition which currently has no effective treatment options and be unable to enroll in a clinical trial. The potential benefit of the treatment must outweigh its risks, and its use must not interfere with ongoing research.

These medical products have not been approved by the FDA, and their safety or effectiveness is not guaranteed. They may help, but they can also cause unexpected serious side effects, according to the FDA’s website.

“We are thrilled that more top-tier U.S. medical centers are recognizing the potential of Namodenoson and are eager to participate in our compassionate use program,” Motti Farbstein, CEO of Can-Fite, said in the news release. “Our goal is to provide this underserved patient population with a novel treatment that may extend survival and improve quality of life.”

Namodenoson recently received FDA approval from the regulatory agency for its first single-patient compassionate use treatment, drawing interest from oncologists at U.S. centers seeking the drug for pancreatic cancer care.

Additionally, Can-Fite is enrolling patients in Israel for a phase 2a open-label trial of Namodenoson for those with advanced pancreatic adenocarcinoma that progressed after first-line therapy.

In the phase 2a multicenter, open-label trial, all patients will receive 25 milligrams of oral Namodenoson twice daily in 28-day cycles and are regularly monitored for safety. The study aims to enroll about 20 evaluable patients.

The primary objective is to assess the safety of Namodenoson, with secondary objectives including clinical activity based on objective response rate, progression-free survival, disease control rate, duration of response and overall survival.

The trial is led by Dr. Salomon Stemmer at the Institute of Oncology, Rabin Medical Center in Israel, and Dr. Al Mutar at UT Southwestern Medical Center, located in Dallas, Texas, in the U.S.

Namodenoson has also received orphan drug designation from the FDA, which is the status granted by the FDA to drugs or biologics intended to prevent, diagnose or treat rare diseases, providing incentives such as tax credits, exemption from user fees and potential seven years of market exclusivity after approval.

Namodenoson is a small oral drug that targets the A3 adenosine receptor (A3AR) with high affinity and selectivity, according to the release. It is being studied in a phase 3 trial for advanced liver cancer, a phase 2b trial for metabolic dysfunction-associated steatohepatitis and a phase 2a trial for pancreatic cancer. A3AR is highly expressed in diseased cells but shows low expression in normal cells, which may contribute to the drug’s strong safety profile.

According to the National Cancer Institute, pancreatic cancer forms in the tissues of the pancreas, an organ in the abdomen that helps the body digest food and use energy. It begins when cells in the pancreas grow uncontrollably and form a tumor.

Most pancreatic cancers start in exocrine cells, which produce digestive juices, and are typically found at an advanced stage. Less commonly, cancer may begin in endocrine cells, which make hormones. These cases usually have a better prognosis, according to the agency.

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