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 it has submitted a study protocol to the U.S. Food and Drug Administration for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer. The FDA has granted Orphan Drug designation to CF102 in this indication. The protocol, which has already been approved by the Institutional Review Board (IRB) in Israel, will also be filed in Europe.
The planned Phase II study will be conducted in Israel, Europe and the U.S. 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. The study will investigate the efficacy and safety of CF102 as compared to placebo.
Dr. Keith Stuart, MD, assisted in developing the study protocol. He is Chairman, Department of Hematology at Lahey Clinic and Oncology Professor of Medicine, Tufts University School of Medicine. Tufts University will participate as the study's U.S. clinical site.
The protocol submission is supported by strong, positive data from Can-Fite's Phase I/II HCC study published in The Oncologist, and presented at the 18th World Congress on Advances in Oncology. The Phase I/II study data demonstrated that the trial objectives were successfully achieved. CF102 had a very favorable safety profile with very encouraging median overall survival and one patient who has been treated for 4 years with CF102. The A3 adenosine receptor (A3AR), which is the target of CF102, was also found to potentially serve as a biomarker to predict patients' reaction to treatment with CF102.
"We are planning to initiate our Phase II trial for advanced liver cancer during the current quarter. Having already received IRB approval in Israel, we look forward to the FDA's response to the protocol. Advanced liver cancer is an indication that is a clear, unmet medical need and we believe the FDA's Orphan Drug Designation for CF102 will support our clinical development path," stated Can-Fite CEO Dr. Pnina Fishman.
According to Global Industry Analysts, the global liver cancer drug market is expected to exceed $2 billion by 2015.