AVI BioPharma data shows benefit to hepatitis C patients

By Elaine Rigoli

Tampa, Fla., May 10 - AVI BioPharma, Inc. released initial data from the second phase of its multi-center study in patients with chronic active hepatitis C virus infection, showing that AVI-4065 exhibited favorable safety and tolerability profiles in all patients treated thus far, with no serious drug-related adverse events or tolerability issues observed during treatment or follow-up.

Based on the relatively long elimination half-life of AVI-4065 and its mechanism of action, an irreversible binding to the viral genome preventing viral protein synthesis, a slow, steady liver loading with test drug was expected in patients with high levels of viral target in the liver, according to a news release.

This correspondingly predicts a slow, steady decrease in viral load over the drug-loading period, the release said.

The pharmacokinetics analysis in patients treated was consistent with this prediction; there was a significant decrease in the concentration of drug in the plasma (Cmax) in hepatitis C patients compared with the normal subjects in the initial phase of the trial.

This was consistent with an increased elimination of drug found in the urine, most likely bound to the virus in the hepatitis C-infected patients.

In addition, there was a significant correlation between viral titer at day one and the extent of reduction in Cmax, further supporting this mechanism of elimination. These observations demonstrate a significant and direct pharmacodynamic response to hepatitis C infection.

Formal results expected around the end of the year. The second phase of the trial has been designed to assess the safety, tolerability, pharmacokinetics and viral and clinical response to treatment with AVI's proprietary Neugene antisense compound, AVI-4065, among hepatitis C patients.

Portland, Ore.-based AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation Neugene antisense drugs.

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