Novelos hep C drug IND accepted by FDA

Massachusetts, USA-based Novelos Therapeutics, a biotechnology firm focused on the development of therapeutics to treat cancer and hepatitis, says that the Food and Drug Administration has accepted its Investigational New Drug application for NOV-205, its second clinical-stage compound. The initial USA-based Phase Ib trial will evaluate NOV-205 as monotherapy for chronic hepatitis C genotype-1 patients who have failed pegylated interferon plus ribavirin therapy.

NOV-205 is designed to act 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 the agent greatly reduced or eliminated hepatitis virus levels for at least 30 days post treatment and significantly improved or normalized serum biochemical markers of liver damage. NOV-205 was well-tolerated in these studies.

The compound's manufacturing is simple and low cost, says Novelos, adding that the USA-based Phase Ib trial aims to expand the safety database for NOV-205 and assess its effects on the same key efficacy-related endpoints that showed improvement in the Russian studies.