FDA grants CF102 orphan drug status to treat HCC in phase 2 trial

The FDA has granted orphan drug status to Can-Fite BioPharma for CF102 to treat advanced liver cancer in a phase 2 multinational clinical trial, according to a press release.

CF102 (Cl-IB-MECA), an oral bioavailable drug, has been developed by Can-Fite to treat hepatocellular cancer (HCC). The study will be conducted at Tufts University School of Medicine in Boston, along with clinical sites in Israel and Europe, and consist of 78 cirrhotic patients who previously failed treatment with sorafenib (Nexavar) for HCC. Patients will be assigned placebo or CF102, according to the release, and be assessed for the drug’s efficacy and safety.

The drug already has completed a phase 1 study, where data revealed an excellent safety profile, lack of hepatotoxicity, prolonged survival time with placebo, regression of skin tumor metastases and stabilized disease in 22% of patients, the release said.

“Advanced liver cancer is resistant to chemotherapy and the only approved drug on the market is Nexavar,” Pnina Fishman, PhD, chief executive officer of Can-Fite, said in the release. “We will treat patients who have no other treatment options.”