Israel-based Can-Fite BioPharma has started dosing in a Phase II trial of CF 102, a small orally bioavailable drug being developed to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.
A total of 78 patients will be enrolled in the randomised, double-blind, placebo controlled Phase II trial, which will be conducted in the US, Europe and Israel.
CF 102 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.
Overall patient survival is the primary endpoint of the trial and the first patient was dosed at the study's Israeli site, the Rabin Medical Centre.
The Phase II trial follows favourable results in the company's Phase I/II trial, which was an open-label, dose-escalation study that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the orally administered CF102 in patients with advanced primary HCC.
Results from the Phase I/II trial showed prolonged survival, stable disease in some patients, and regression of skin tumour metastases, as well as a favourable safety profile and lack of hepatotoxicity.
Can-Fite CEO Dr Pnina Fishman said: "We believe we have reached an important milestone in this trial by commencing the dosing of patients with CF102.
"We are proud to be working with some of the top medical institutions in the world on this trial, including Tufts Medical School in the US and the Rabin Medical Centre in Israel.
"As we continue to screen for new patients, we look forward to advancing the trial towards full enrolment.
"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."
The company said that 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 candidate for use in liver cancer.
CF102 binds with high affinity and selectivity to the A3 adenosine receptor (A3AR), which is highly expressed in tumour cells, whereas low expression is found in normal cells.