Can-Fite BioPharma Ltd. (TASE:CFBI; NYSE MKT: CANF) today announced that the US Food and Drug Administration (FDA) had granted its CF102 research drug fast track status as a second-line therapy for Hepatocellular Carcinoma (HCC) liver cancer, considered the most common type of liver cancer.
The FDA has already granted CF102 orphan drug status.
Can-Fite is currently conducting a Phase II study along these lines in several countries. 78 liver cancer patients also suffering from advanced cirrhosis of the liver who have already unsuccessfully tried the only FDA-approved drug for their condition are participating in the trial.
Fast track status will enable the company to expedite development of CF102, since drugs with this status benefit from frequent meetings and agreements with the FDA for reviewing the clinical trial results during the development of the drug, and from support in its approval.
"We’re very satisfied that the FDA has recognized the potential of our CF102 drug for treatment of HCC patients who did not respond to Nexavar, the only approved drug in the market for this problem," Can-Fite CEO Pnina Fishman said. "We regard receiving fast track status as a significant catalyst for the CF102 development program, and believe that it is important news for the patients."
Published by Globes [online], Israel business news - www.globes-online.com - on September 17, 2015
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