8 May 2019 - - Israel-based biotechnology company Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) 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 said.

The company recently released 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 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 US 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 for review prior to completing the entire application for commercialisation.

Orphan Drug designation includes seven-year market exclusivity following marketing approval, FDA assistance during the drug development process, and exemption of application fees.

Liver cancer expert 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.

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.

Can-Fite has engaged the services of a clinical research organization, the Weinberg Group, based in Washington DC to help with the preparation of all materials for the FDA meeting.

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor.

Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis.

A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Can-Fite BioPharma is an advanced clinical stage drug development company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.

The company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis.