The US FDA grants fast track designation to Coley Pharmaceutical's Actilon (CPG 10101) for use in treatment-refractory patients chronically infected with the Hepatitis C virus (HCV).
"A fast track designation for our Actilon development program allows Coley to work closely and expeditiously with the FDA to potentially benefit patients who currently have no other treatment alternatives," said Ferdinand E. Massari, Senior VP, drug development and Chief Medical Officer of Coley Pharmaceutical Group.
Actilon is an investigational Toll-like receptor 9 (TLR9) agonist designed to induce both rapid and sustained immune responses that can have durable anti-viral effects.
A 48-week phase II clinical study evaluating safety and activity of Actilon in combination with pegylated interferon and ribavirin is currently enrolling treatment-refractory HCV patients who never responded after a minimum of 12 weeks of pegylated interferon and ribavirin treatment.
Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoSmithKline and the United States government.