• US stock market daily report (September 17, 2015, Thursday)

    The U.S. Food and Drug Administration (FDA) has granted fast track designation for Can-Fite BioPharma Ltd. (CANF - NYSE) drug candidate CF102 for treatment of the most common form of liver cancer, hepatocellular carcinoma (HCC).

    Can-Fite is a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases.

    During early morning trading on Thursday, shares of CANF were higher by 45%.

    Dr. Pnina Fishman, Can-Fite CEO 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."

    The company is currently in the midst of a Phase II study of the drug in the United States, Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, NexavarŽ (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

    In a statement from Can-Fite, during 2015, the global market for liver cancer drugs is expected to top $2 billion.

    CF102 has already received FDA Orphan Drug designation.

    Contributed by Millennium Traders
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