AVI BIOPHARMA BEGINS HEPATITIS C TRIAL

AVI BioPharma has begun an exploratory safety and efficacy clinical trial using its proprietary NEUGENE antisense compound AVI-4065. The multicenter study will assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI-4065 among healthy volunteers and patients with chronic active hepatitis C virus (HCV).

The multicenter clinical trial will include 80 subjects: 40 healthy adult volunteers in the first phase of the study and 40 patients with chronic active HCV in the second phase. In the first phase, up to four dosage levels will be evaluated to confirm the safety of desired serum drug levels. In the second phase, 40 patients with chronic active HCV will be enrolled, including patients who are drug-naive and patients who have failed conventional interferon and ribavirin treatment.

This phase of the trial will assess the safety, tolerability, pharmacokinetics, biological responses and HCV virological effects of AVI-4065 over a minimum of 14 days of treatment. Patients will be monitored following treatment to assess a sustained HCV virological response to AVI-4065