Coley Pharmaceutical has reported results from the company's Phase Ia and Ib
clinical studies of Actilon, Coley's investigational therapeutic for hepatitis
C virus (HCV).
The Phase Ia normal volunteer study was designed to evaluate Actilon's safety, dose tolerability and immunological activity. The study randomized 40 healthy volunteers within five sequential dosing cohorts. Two subcutaneous injections were administered double-blind fourteen days apart and subjects were evaluated for a total of 29 days. An immune system response demonstrating drug-related increases in interferon-alpha levels and other markers indicative of antiviral activity was observed over the course of treatment.
Volunteers had no drug-related serious adverse events or dose-limiting toxicities. Mild injection site reactions and mild-to-moderate flu-like symptoms were consistent with the pharmacological mode of action of Actilon.
The Phase Ib study enrolled 60 chronic hepatitis C patients and was designed to evaluate safety and tolerability of Actilon over a wide dose range among patients who had relapsed after or were intolerant to prior interferon-alpha therapy. Subjects were randomized to receive doses of Actilon at 0.25, 1, 4, 10, and 20 mg twice weekly or 0.5 or 0.75 mg/kg once weekly or placebo for four weeks. Dose tolerance and laboratory safety were the same in HCV patients as in normal volunteers receiving equivalent doses.