FDA gives orphan drug status to Cleveland BioLabs’ phase 1 drug for liver cancer

A liver cancer drug being developed by a joint venture between Cleveland BioLabs (NASDAQ:CBLI) and a Russian-based venture fund was granted orphan drug status by the U.S. Food and Drug Administration this week.

Curaxin CBL0102, an oral treatment for hepatocellular carcinoma, is currently being evaluated in phase 1 clinical trials in Russia. The most common form of liver cancer is diagnosed in half a million people globally each year, about 20,000 of which are in the United States, making the therapeutic eligible for certain orphan drug benefits including seven years of market exclusivity upon approval.

Incuron LLC, the company developing and commercializing the drug, was formed in 2010 as a collaboration between Bioprocess Capital Ventures and Cleveland BioLabs. The latter was founded in partnership with the Cleveland Clinic in 2003 and relocated to Buffalo, New York, in 2007. Its lead candidate is a compound intended to protect health cells from damage by radiation that also has orphan drug status.


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