Ph 3 pivotal Namodenoson HCC study recruiting in medical centers in Europe, Israel and the US
“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.”
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