EMA grants orphan drug designation to CF102 for HCC

The European Medicines Agency has granted orphan drug designation to Can-Fite BioPharma Ltd.’s CF102, a potential drug to treat hepatocellular carcinoma, according to a press release.

The designation includes CF102 benefiting from protocol assistance and a 10-year market exclusivity following market authorization in the 28 European Union Member states, as well as three additional European Economic Area countries, according to the release.

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

“The EMA's orphan drug designation for CF102 is the latest in a series of catalysts that we believe are accelerating the clinical development path of our liver cancer drug towards market approval,” Pnina Fishman, PhD, CEO of Can-Fite, said in the release. “As we actively recruit patients in our phase 2 study of CF102 in Europe, we are pleased the [European Medicines Agency] will support CF102 through protocol assistance and post-authorization market exclusivity.”

A placebo-controlled phase 2 study is currently underway and includes patients with HCC undergoing treatment with 25 mg of CF102 twice daily, which has been found to be the most efficacious dose for the longest overall survival time, according to the release. The trial is expected to complete full enrollment of 78 patients with Child-Pugh Class B cirrhosis who failed prior treatment with Nexavar (sorafenib, Bayer) by the end of the first half of 2016.

Can-Fite received fast track designation from the FDA for CF102 in September and a patent from the European Union in 2014.

Disclosures: Fishman reports being employed by Can-Fite BioPharma.