Can-Fite Updates on its Advanced Liver Cancer Pivotal Phase 3 Study
Namodenoson granted Orphan Drug and Fast track status from the FDA
In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.
Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the
The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
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