Can-Fite BioPharma, a biotech company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, has submitted phase II study protocol for the treatment of advanced liver cancer with its CF102 drug candidate.

The company also plans to conduct the phase II study in Israel, Europe and the US and will include 78 subjects (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. The study will investigate the efficacy and safety of CF102 vs. placebo. The protocol has been submitted to the ethics committee (EC) in Israel and the company intends to follow up with European and US submissions shortly.

The study protocol was developed with the assistance of Dr Keith Stuart, MD, chairman, Department of Hematology and Oncology Professor of Medicine, Tufts University School of Medicine a well-known internationally expert in Liver Cancer.

The US Food and Drug Administration (FDA) has granted Orphan Drug designation for CF102, for the treatment of hepatocellular carcinoma.

According to Global Industry Analysts, the global liver cancer drug market is expected to exceed $2 billion by 2015.

The company reported earlier that data from the phase I/II study was published recently in The Oncologist, one of the leading journals in this field, and was presented at the 18th World Congress on Advances in Oncology. The company reported that the phase I/II study data demonstrated 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. In addition, the median overall survival time was very encouraging given that most patients were treated in the second-line setting and some were Child-Pugh Class B. Another finding indicated that the A3 adenosine receptor, which is the target of CF102, can serve as a biomarker to predict the patients' reaction to treatment with CF102. Interestingly, one of the patients included in the phase I/II study has been treated for 4 years with CF102 and is continuing to be treated, with CF102.

CF102 is a small orally bioavailable drug which 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 our pre-clinical and clinical studies, CF102 induces a robust anti-tumour effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

Can-Fite BioPharma is focused on the development of small molecule orally bioavailable drugs, in particular, ligands that bind to the A3 adenosine receptor.