Can-Fite BioPharma, a biotechnology company, has submitted Phase II study protocol for CF102 drug candidate for the treatment of patients with advanced liver cancer.
The company is likely to conduct the Phase II study for CF102 in Israel, Europe and the US. This study is designed to assess the safety and efficacy of CF102 compared to a placebo.
The Phase II study will include 78 patients (less than what has been reported previously since the company is treating a patient population with a more advanced disease) with second-line treatment of advanced hepatocellular carcinoma with Child-Pugh Class B cirrhosis.
Can-Fite BioPharma has submitted the Phase II study protocol to ethics committee in Israel and the company plans to follow up with European and US submissions shortly.
The company has developed the study protocol with the assistance of Tufts University School of Medicine Department of Hematology and Oncology Professor of Medicine chairman Dr Keith Stuart.
CF102 has already obtained orphan drug designation from the US Food and Drug Administration for the treatment of hepatocellular carcinoma.
Previously, Can-Fite BioPharma has reported that data from the Phase I/II study was published in The Oncologist.
The company reported that the Phase 1/II study data showed that the trial objectives were successfully achieved, demonstrating a very favorable safety profile for CF102 in a patient population with hepatocellular carcinoma and Child-Pugh cirrhosis classes A and B.
CF102, a small orally bioavailable drug, binds with high affinity and selectivity to the A3 adenosine receptor. The latter is highly expressed in tumor cells whereas low expression is found in normal cells.
This differential effect accounts for the excellent safety profile of the drug. In pre-clinical and clinical studies, CF102 induces a robust anti-tumor effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.