Can-Fite Announces Preparation for End-of-Phase II Meeting with FDA to Initiate the Phase III Liver Cancer Study for Namodenoson

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today it is conducting preparatory work for a planned pivotal Phase III study of its drug candidate Namodenoson in the treatment of advanced liver cancer in patients as a first line and second line treatment. The Company recently announced results from its Phase II study of Namodenoson in the treatment of advanced liver cancer. 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 based on unmet need in the treatment of advanced liver cancer. Fast Track designation offers advantages including more frequent meetings with the FDA and rolling review, which provides the opportunity to submit parts of its New Drug Application (NDA) for review prior to completing the entire application for commercialization. Orphan Drug designation includes 7-year market exclusivity following marketing approval, FDA assistance during the drug development process, and exemption of application fees.

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. Dr. Llovet is the Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine, New York University, and Professor of Research-ICREA Liver Unit, IDIBAPS-Hospital Clinic, University of Barcelona.

Dr. Llovet commented, "Today, patients with advanced liver cancer and severe liver dysfunction do not have any accepted standard of care that is effective. Based on Namodenoson’s signal of efficacy in the recently completed Phase II trial, a Phase III study in the population of patients with HCC Child Pugh B7 is warranted and I am pleased to help with the design of the Phase III study and to serve as the Principal Investigator of the trial.”