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news.Can-Fite BioPharma has began dosing in a Phase II trial of CF 102 to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.
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The company said that around 78 patients will be enrolled in the randomized, double-blind, placebo controlled Phase II trial that will be conducted in the US, Europe and Israel.
CF 102, a small orally bioavailable drug, is currently being assessed for efficacy and safety as a second-line treatment for advanced HCC in subjects with Child-Pugh B who failed Nexavar as a first line treatment.
The trial’s primary endpoint is overall patient survival and the first patient was dosed at the study’s Israeli site, the Rabin Medical Centre.
The Phase II trial follows favorable results from the company’s Phase I/II trial, which was an open-label, dose-escalation trial that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the orally administered CF102 in patients with advanced primary HCC.
Data from the Phase I/II trial showed prolonged survival, stable disease in some patients, and regression of skin tumor metastases, as well as a favourable safety profile and lack of hepatotoxicity.
Can-Fite CEO Dr Pnina Fishman said: "If the Phase II data show results similar to our Phase I/II study, we believe this would indicate that CF102 may offer clear benefits and a prolonged life for liver cancer patients."
CF 102 also received orphan drug status from the US Food and Drug Administration (FDA) to treat HCC, while Israel’s Ministry of Health has also approved the drug for use in liver cancer.