Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced today it has submitted an application to the European Medicines Agency for Orphan Drug Designation for its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.
CF102 is currently in a Phase II trial in the U.S., Israel, and Europe. The study enrolls HCC patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). The patients are treated twice daily with 25 mg of CF102, which has been found to be the most efficacious dose in our earlier Phase I/II study resulting in the longest overall survival time. CF102 is a stable drug which is hardly metabolized in the liver and therefore is suitable for treatment of liver diseases. In addition, the 25 mg dose had an excellent safety profile in the Phase I/II study and showed no hepatotoxicity and even maintained liver function in patients with advanced liver disease.
Can-Fite has already been granted Orphan Drug Status for CF102 for the indication of HCC by the U.S. Food and Drug Administration. CF102 is also approved for Compassionate Use by Israel's Ministry of Health.
If CF102 is granted Orphan Drug Designation in Europe, Can-Fite would benefit from incentives including protocol assistance, fee reductions, and market exclusivity once the medicine is on the market for up to 10 years in European Union member nations.
"As we are currently conducting our Phase II 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. 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 III study protocol," stated Pnina Fishman, CEO of Can-Fite. "Upon marketing approval, receiving market exclusivity for CF102 would be significantly beneficial to Can-Fite."
According to Global Industry Analysts, the global market for liver cancer is projected to exceed $2 billion by 2015.