Benzinga | Dec 20, 2021 07:03AM EST

Can-Fite BioPharma Announces Liver Cancer Patient Treated With Can-Fite's Namodenoson Clears All Cancer Lesions Under Open Label Extension of Phase II Study

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an-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that the last patient treated under an Open Label Extension program of its concluded Phase II study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, experienced a Complete Response (CR) to Can-Fite's drug, meaning that all cancer lesions have cleared.

Under treatment with Namodenoson, the patient has now survived five years, during which time the clinical benefits of treatment have included the disappearance of ascites, normal liver function, and the disappearance of peritoneal carcinomatosis leading to complete clearance of all cancer lesions.

"Complete Response of HCC in an advanced stage is a rare but highly beneficial result in the field of liver cancer treatment. We are pleased that Namodenoson has contributed to the restored health and quality of life for this patient and family. It is our hope that our upcoming pivotal Phase III study will demonstrate Namodenoson's efficacy in treating patients with similarly advanced HCC and thereby potentially offer longer survival to liver cancer patients across the world," stated Can-Fite's Medical Director Dr. Michael Silverman.

In the first quarter of 2022, Can-Fite expects to commence patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed with the design of the 471-patient study. Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel.