13th Feb，2020– Can-Fite BioPharma Ltd. issued an announcement, which is summarized as follows:
Can-Fite successfully concluded its End-of-Phase II meeting with the U.S. FDA recently
One Phase III trial for concurrent regulatory approval in U.S. and Europe upon successful study results
Namodenoson has Orphan Drug and Fast Track status, addressing projected $3.8 B market
Can-Fite announced today it has submitted the study’s protocol design and registration plan for its pivotal Phase III liver cancer trial to the European Medicines Agency’s (EMA) Committee for Medicinal Product and Human Use (CHMP). The Phase III pivotal trial will evaluate the efficacy of its drug candidate Namodenoson in patients with advanced hepatocellular carcinoma (HCC), with underlying Child Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line therapy.
The filing with the EMA follows Can-Fite’s successful conclusion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA), in which the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval of Namodenoson in the treatment of HCC.
“Having submitted our study design to both U.S. and European regulators, we look forward to initiating this Phase III study. Should Namodenoson meet the study’s primary endpoint of improved overall survival for liver cancer patients, then we intend to file for concurrent approval of our drug in both the U.S. and Europe, two of the largest healthcare markets in the world,” stated Can-Fite CEO Dr. Pnina Fishman.
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