The US Food and Drug Administration (FDA) has granted Israel-based biotech company Can-Fite BioPharma's (TASE: CFBI) drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer.
The news pushed Can-Fite’s shares up nearly 40% to $2.32 in early US market activity in robust trading. CF102 had already received the FDA's Orphan Drug designation.
Can-Fite is currently conducting a Phase II study for this indication in the UA., 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, German pharma major Bayer’s (BAYN: DE) Nexavar (sorafenib). Patients are treated twice daily with 25mg 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.
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