Can-Fite applies for EMA orphan drug designation for liver cancer drug

Can-Fite BioPharma Ltd. has submitted an application to the European Medicines Agency for orphan drug designation of CF102 for the treatment of hepatocellular carcinoma, according to a press release from the manufacturer.

If granted orphan drug designation in Europe, Can-Fite would benefit from incentives including protocol assistance, fee reductions and market exclusivity once CF102, an oral molecular bioavailable drug, is on the market for up to 10 years in European Union member nations, according to the release.

“As we are currently conducting our phase 2 trial for CF102 in the treatment of liver cancer, we believe this is an opportune time for us to apply for orphan drug designation in Europe,” Pnina Fishman, PhD, chief executive officer of Can-Fite, said in the release. “If our phase II study results are favorable, then this designation would grant us the European Medicines Agency's valuable assistance in the development of our phase 3 study protocol. Upon marketing approval, receiving market exclusivity for CF102 would be significantly beneficial to Can-Fite.”

The drug is currently being investigated in a phase 2 trial in the U.S., Israel and Europe.

The study includes 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 25 mg dose had an excellent safety profile in the phase 1/2 study and showed no hepatotoxicity and even maintained liver function in patients with advanced liver disease, according to the release.

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

Disclosure: Fishman is an employee of Can-Fite.