Can-Fite wins FDA orphan drug status for liver cancer drug

CF102 was found to be safe in preclinical and Phase I clinical trials.

Can-Fite BioPharma Ltd. (TASE:CFBI) has obtained US Food and Drug Administration (FDA) Orphan Drug Status for its drug, CF102 for the treatment of liver cancer (hepatocellular carcinoma).

Orphan Drug Status is granted for drugs being developed for treating diseases that affect a small number of people - in the US, the figure is 200,000 people. The status provides incentives and preferences for the research, production and marketing of these drugs, including seven years marketing exclusivity from the date of approval, tax breaks, and exemptions on FDA fees.

CF102 is an oral small molecule. It was found to be safe in preclinical and Phase I clinical trials.

630,000 new cases of liver cancer are diagnosed a year, mostly in Asia.

Can-Fite CEO Dr. Pnina Fishman said, "Obtaining Orphan Drug Status for CF102 for the treatment of liver cancer is an important regulatory step in the drug's development, providing numerous incentives and protections that will facilitate its development for liver cancer and exclusive marketing rights.

In a separate development, Can-Fite subsidiary OpththaliX Inc. (Bulletin Board: OPLI) has obtained a Chinese State Intellectual Property Office patent for the company's drug candidate CF101. This will give OphthaliX exclusive rights for the use of CF101 to treat dry eye syndrome in China until February 2026.

Fishman said, "We are currently enrolling patients for the ongoing Phase III multinational study of this pioneered oral drug for the treatment of dry eye syndrome."

Can-Fite's share price rose 9% by early afternoon to NIS 0.49, giving a market cap of NIS 127 million. OpththaliX's share price was unchanged yesterday on Wall Street at $3.10, giving a market cap of $146 million.

Published by Globes [online], Israel business news - - on February 22, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018