Novelos begins recruitment in hepatitis C study

The initial phase Ib trial will evaluate NOV-205 versus placebo as monotherapy in 30 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin.

NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. Its regulatory approval in the Russian Federation was based on clinical studies in hepatitis B and C patients in which NOV-205 greatly reduced or eliminated hepatitis viral levels for at least 30 days post treatment.

The phase Ib trial aims to expand the safety and pharmacokinetic database for NOV-205 and assess its effects on the same key efficacy-related endpoints that showed improvement in the previous studies.

The current standard-of-care drugs for chronic hepatitis C are expensive, have significant toxicities, are difficult to tolerate for many patients and have limited long-term efficacy in genotype 1 patients which is the most common HCV genotype seen in the US. Approximately 50% of the genotype 1 patients are non-responders to standard therapy, and currently there is no approved standard of care to treat these chronic HCV patients.

Novelos said they expected results form the trial in the first half of 2007.