Can-Fite Biopharma Completes End-of-Phase 2 with FDA; Agreement Reached on Phase 3 Trial Design to Support NDA Submission

Can-Fite Biopharma Completes End-of-Phase 2 with FDA; Agreement Reached on Phase 3 Trial Design to Support NDA Submission

Can-Fite Pharma announced the successful completion of an End-of-Phase 2 meeting with the U.S. FDA regarding its recently completed Phase II study of namodenoson in the treatment of hepatocellular cancer (HCC). The purpose of the meeting was to review the Phase II study data with the FDA and to present Can-Fite’s proposed Phase III study design to support a New Drug Application (NDA) submission and approval.

The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design. The Phase III study is designed to enroll patients with advanced HCC, with underlying Child-Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first-line therapy. Previously announced Phase II trial data showed promising efficacy signals in this population. The FDA’s guidance will be incorporated into the Phase III study’s final protocol.

Results from a phase 2, randomized, double-blind, placebo-controlled study were presented at the International Liver Cancer Association (ILCA) annual conference on September 22, 2019.  While the Phase II study did not achieve its primary endpoint of overall survival in the whole population (n=78), superiority in overall survival was found in the largest study subpopulation of patients who were classified Child-Pugh B7 (CPB7, n=56) based on the severity of the underlying cirrhosis, as compared to the placebo-treated group. The median overall survival in the CPB7 population was 6.8 months for those treated with namodenoson as compared to 4.3 months for those treated with placebo.

About Namodenoson 

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). 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. 

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common primary tumor of the liver. Most people have an underlying liver disease such as infection with hepatitis B or C virus, or non-alcoholic fatty liver disease. Many people also have cirrhosis, which is scarring of the liver that can occur as a result of chronic liver diseases. If HCC is found early, there may be curative treatments offered. However, HCC often does not cause any symptoms, especially early in the disease course. If HCC is diagnosed at a late stage, patients may not be able to receive curative treatments, and care is then geared toward helping people have a better quality of life.