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FDA Gives Fast-Track Designation to CF102 for Hepatocellular Carcinoma
The FDA has granted a fast-track designation to CF102 (Can-Fite BioPharma Ltd.), a potential treatment for hepatocellular carcinoma (HCC).
CF102, an oral molecular bioavailable drug, acts as an agonist at the A3 adenosine receptor and has demonstrated antitumor effects in multiple phase I and III clinical trials; use of CF102 resulted in liver cancer-cell death, according to Can-Fite.
CF102 is being investigated for the treatment of HCC in a phase II, randomized, placebo-controlled study in the U.S., Europe, and Israel. The 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 treatment with sorafenib (Nexavar, Bayer). The enrolled patients are treated with 25 mg of CF102 twice per day. This dosage has been found to be safe and efficacious in previous phase I and II clinical trials, according to Can-Fite.
Can-Fite received an orphan drug designation from the FDA for CF102 and a patent from the European Union in 2014.
Source: Healio; September 17, 2015.