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news.The US Food and Drug Administration (FDA) has granted fast track designation to Can-Fite BioPharma's CF102 drug candidate in the treatment of hepatocellular carcinoma (HCC) liver cancer.
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Can-Fite has already secured the FDA’s Orphan Drug designation for CF102, which is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR).
The company is currently undertaking a Phase II randomized, double blind, placebo controlled study for the indication in the US, Europe and Israel.
Enrollment is anticipated to be completed by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the Nexavar (sorafenib) drug.
Patients are treated twice daily with 25 mg of oral CF102, which has been identified to be the most efficacious dose in Can-Fite’s previous Phase I/II study, leading to the longest overall survival time, with better safety results.
Can-Fite CEO Pnina Fishman said: "We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication.
"We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."
Global Industry Analysts estimates that the worldwide market for liver cancer drugs will cross $2bn in 2015.