Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced that it has dosed the first patient in a Phase II trial for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.
The Phase II randomized, double-blind, placebo controlled trial is to be conducted in the U.S., Europe and Israel with an estimated 78 patients to be enrolled. CF 102 is being evaluated for efficacy and safety as a second-line treatment for advanced HCC in subjects with Child-Pugh B who failed Nexavar as a first line treatment. The first patient was dosed at the study's Israeli site, the Rabin Medical Center. The primary endpoint of the study is overall patient survival.
This Phase II study follows favorable results in Can-Fite's Phase I/II study, which was an open-label, dose-escalation study that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the orally administered CF102 in patients with advanced primary HCC. Data from that trial showed prolonged survival, stable disease in some patients, and regression of skin tumor metastases, as well as a favorable safety profile and lack of hepatotoxicity.
"We believe we have reached an important milestone in this trial by commencing the dosing of patients with CF102. We are proud to be working with some of the top medical institutions in the world on this trial, including Tufts Medical School in the U.S. and the Rabin Medical Center in Israel. As we continue to screen for new patients, we look forward to advancing the trial towards full enrollment," stated Can-Fite CEO Dr. Pnina Fishman.
"If the Phase II data show results similar to our Phase I/II study, we believe this would indicate that CF102 may offer clear benefits and a prolonged life for liver cancer patients," Dr. Fishman added.
The U.S. Food and Drug Administration has granted Orphan Drug Status to Can-Fite's CF 102 for this indication. Israel's Ministry of Health has also approved CF102 for Compassionate Use in liver cancer. Global Industry Analysts predicts that the global market for liver cancer is projected to exceed $2B by 2015.