Phase 2 trial initiated in Europe for CF102 for HCC

Can-Fite BioPharma Ltd. announced the European Medicines Agency approved a phase 2 clinical trial for CF102, a potential drug treatment for hepatocellular carcinoma, and has already dosed its first patient in Europe, according to a press release from the manufacturer.

The phase 2 study is part of a randomized, double-blind, placebo-controlled trial that is currently being conducted across the United States, Israel and Europe. The study includes 78 patients with HCC and Child-Pugh Class B cirrhosis who failed previous therapy with Nexavar (sorafenib, Bayer Healthcare). The patients are treated twice daily with 25 mg of CF102. The study will investigate the safety and efficacy of CF102 compared with placebo.

“There are no treatment options for patients with advanced liver cancer who have not benefitted from treatment with Nexavar, the only FDA-approved drug on the market for this indication,” Pnina Fishman, PhD, chief executive officer of Can-Fite, said in the release. “As patients, who have virtually no other options, are being dosed with CF102, it is certainly our hope that the drug will be of benefit to them.”

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.

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

Disclosure: Fishman is an employee of Can-Fite.