6thMay 2019 – Can-Fite BioPharma Limited issued an announcement, which is summarized as follows:
Can-Fite BioPharma Ltd. announced today it is conducting preparatory work for a planned pivotal Phase III study of its drug candidate Namodenoson(CF102) in the treatment of advanced liver cancer in patients as a first line and second line treatment. Namodenoson was found to increase overall survival in hepatocellular carcinoma (HCC) patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint.
An end of Phase II meeting with the U.S. Food and Drug Administration to review study data and to present the design of the Phase III clinical trial is expected soon. The FDA has granted Namodenoson both Orphan Drug and Fast Track status providing a pathway for accelerated approval.
Key Opinion Leader in liver cancer, Dr. Josep Llovet is slated to be the Principal Investigator of the planned Phase III trial and is currently working closely with Can-Fite on the study’s protocol and design.
In addition, Can-Fite has engaged the services of a clinical research organization (CRO), the Weinberg Group, based in Washington DC to help with the preparation of all materials for the FDA meeting.
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