FDA grants fast track designation to CF102 for HCC

The FDA has granted fast track designation to Can-Fite BioPharma Ltd.’s CF102, a potential drug to treat hepatocellular carcinoma, according to a press release.

CF102, an oral molecular bioavailable drug, acts as an agonist at the A3 adenosine receptor and has demonstrated antitumor effects in multiple phase 1 and 2 clinical trials, resulting in liver cancer cell death, according to Can-Fite.

CF102 is currently being investigated for the treatment of HCC in a phase 2 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 B cirrhosis who failed treatment with Nexavar (sorafenib, 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 1 and 2 clinical trials, according to Can-Fite.

“We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar,” Pnina Fishman, PhD, CEO of Can-Fite, said in the release. “We consider fast track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.”

Can-Fite received orphan drug designation from the FDA for CF102 and a patent from the European Union in 2014.

Disclosures: Fishman reports being employed by Can-Fite.