Last Liver Cancer Patient In Phase II Trial of Namodenoson Found Cleared Of All Lesions
Can-Fite BioPharma today shared that the last patient included in its Phase II trial on the use of Namodenoson to treat hepatocellular carcinoma has survived five years since the start of treatment thus far and has been cleared of all cancer lesions.
In a statement, the company said that the patient experienced a normal liver function and the disappearance of ascites and peritoneal carcinomatosis, eventually leading to total clearance of cancer lesions. Under the concluded Phase II open label extension program, the patient was given the orally bioavailable drug Namodenoson. The drug works by binding with A3 adenosine receptors (A3AR). A3AR is abundant in diseased cells.
Namodenoson was assessed in the trial either as a treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It was also assessed as second line therapy for hepatocellular carcinoma (HCC), the most common type of liver cancer.
"Complete response of HCC in an advanced stage is a rare but highly beneficial result. We are pleased that Namodenoson has contributed to the restored health and quality of life for this patient and family. It is out hope that our upcoming pivotal Phase III study will demonstrate Namodenoson's efficacy in treating patients with similarly advanced HCC and, thereby, potentially offer longer survival to liver cancer patients across the world," commented Dr. Michael Silverman, the medical director of Can-Fite.
The positive results empowered Can-Fite to get started on patient enrollment for its Phase III study by the first quarter of 2022. The 471-participant Phase III study will evaluate the drug on patients with advanced HCC with underlying Child Pugh (CPB7) cirrhosis to support its New Drug Application with the U.S. Food and Drug Administration.
The participants will be given either 25 mg of the drug or a matching placebo twice a day, with the primary endpoint of overall survival. Other outcomes, such as safety, tumor radiographic response rates, and median progression-free survival, will also be evaluated. The study's design already has the approval of the FDA and the European Medicines Agency (EMA).
Liver cancer is responsible for over 700,000 deaths worldwide every year. HCC is an aggressive type with poor survival rates.
As of this writing, Namodenoson is already being used in Israel to treat liver cancer patients via a compassionate use program. It also has an Orphan Drug Designation for HCC in Europe and the U.S. and a Fast Track Status in the latter.