Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that the U.S. FDA has agreed with the Company's study protocol for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer. The FDA has granted Can-Fite Orphan Drug designation for CF102 in this indication.
The planned Phase II study will be conducted in the U.S., Europe, and Israel with 78 subjects who will be dosed with CF102 as a second-line treatment of advanced hepatocellular carcinoma (HCC) with Child-Pugh Class B cirrhosis in patients who have failed sorafenib, an FDA approved drug for the treatment of HCC. The study will investigate the efficacy and safety of CF102 as compared to placebo.
Tufts University School of Medicine is the study's U.S. clinical site. Dr. Keith Stuart, MD, will serve as Principal Investigator for the study at Tufts. He is Chairman, Department of Hematology at Lahey Clinic and Oncology Professor of Medicine, Tufts University School of Medicine.
Data from Can-Fite's completed Phase I/II study demonstrated an excellent safety profile, lack of hepatotoxicity, prolonged survival time as compared to placebo, regression of skin tumor metastases, and a stabilization of the disease in 22% of patients.
HCC, the most common form of liver cancer, is the 4th most common cancer in the world, according to information published by the National Cancer Institute. In the United States, the American Cancer Society estimates there will be 33,190 new cases diagnosed in 2014 and 23,000 deaths due to the disease. As reported by the American Cancer Society, globally each year 700,000 people are diagnosed with HCC each year and 600,000 people die of this cancer. The relative 5-year survival rate from liver cancer is about 15% in the U.S. According to Global Industry Analysts, the global liver cancer drug market is expected to exceed $2 billion by 2015.
"Advanced liver cancer is resistant to chemotherapy and the only approved drug on the market is Nexavar (sorafenib). We will treat patients who have no other treatment options," stated Can-Fite CEO Dr. Pnina Fishman.