Cleveland BioLabs said Tuesday that a cancer drug being developed by its joint venture with a Russian venture capital fund has been granted status as an “orphan drug,” making it eligible for accelerated development, easier final approval and tax breaks.
The Buffalo-based biotechnology company and its Russian-based joint venture, Incuron LLC, said the U.S. Food and Drug Administration has approved the special status for its orally administered CBL0102 drug, called quinacrine, for the treatment of a form of liver cancer known as “hepatocellular cancer.”
The company is already in the midst of a Phase 1 clinical trial in Russia in patients with advanced cancers where standard therapy either hasn’t worked or doesn’t exist.
An “orphan disease” is a rare condition that affects only a small part of the population, and, as such, is often not a subject of major research and drug development because the benefits would be outweighed by the normal research costs. Congress passed the Orphan Drug Act of 1983 to encourage drug companies to develop medications for diseases that have a small market, allowing them to sell it without competition for seven years and qualifying them for tax incentives during the clinical trial period.
There are about 30,000 U.S. cases and 45,000 European cases of “hepatocellular” cancer each year, with a survival rate of 15 percent. However, designation as an “orphan drug” does not yet mean the drug is safe, effective or legal to produce in the U.S.
Incuron was formed in 2010 as a collaboration between Cleveland BioLabs and Russian venture fund Bioprocess Capital Ventures.