FDA Grants Fast Track Designation To Can-Fite'CF102 In Treatment Of Liver Cancer

(RTTNews) - Can-Fite BioPharma Ltd. (CANF) announced the U.S. Food and Drug Administration has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma or HCC, the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar annual sales, as reported by Bayer, were 773 million euros in 2014.