Can-Fite BioPharma has concluded a meeting with an European Medicines Agency (EMA) committee about Phase III clinical trial of Namodenoson to treat hepatocellular carcinoma (HCC).
Namodenoson is an adenosine A3 receptor (A3AR) agonist. A3AR is known to be highly expressed in diseased cells with low expression in normal cells.
In a prior Phase II trial, the drug prolonged median overall survival (OS) in select HCC patient population.
EMA provided scientific advise for Can-Fite to conduct a Phase III registration trial of the drug in patients with HCC and Child Pugh Class B7 (CPB7) cirrhosis.
The company is said to have gathered enough regulatory input to perform a registration trial according to EU and US regulatory requirements.
The proposed randomised, double blind, placebo controlled trial is set to enrol about 450 HCC patients with underlying CPB7 cirrhosis at several centres across the world.
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Patients will be given oral treatment with 25mg dose of the drug or matching placebo twice daily.
The primary efficacy endpoint of the study is overall survival (OS), contingent on the favorable OS response observed in the Phase II trial in patients with HCC and CPB7 cirrhosis.
Other trial efficacy outcomes include tumour radiographic response rates and median progression-free survival, along with standard safety parameters.
Can-Fite BioPharma CEO Dr Pnina Fishman said: “We appreciate the EMA’s advice which, combined with the input we received last October from the US FDA along with recommendations from our academic key opinion leaders, gives us excellent guidance for conducting a successful Phase III clinical and registration programme.”
The drug was also evaluated in a Phase II clinical trial, where it reached efficacy and safety endpoints in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).