Novelos gets FDA OK of Investigational New Drug application for hepatitis C drug

By Elaine Rigoli

Tampa, Fla., April 24 - The Food and Drug Administration has accepted Novelos Therapeutics, Inc.'s Investigational New Drug application for NOV-205, its second clinical-stage compound.

The initial U.S.-based phase 1b trial will evaluate NOV-205 as monotherapy for chronic hepatitis C genotype 1 patients who have failed pegylated interferon plus ribavirin therapy, the company said in a news release.

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 NOV-205 greatly reduced or eliminated hepatitis viral levels for at least 30 days post treatment and significantly improved or normalized serum biochemical markers of liver damage, the release said.

The U.S.-based phase 1b 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.

"In addition to being a phase 3 cancer company with NOV-002, Novelos has now commenced a U.S. clinical development program with NOV-205 in chronic hepatitis C - an indication with a large patient population and a major unmet medical need. We plan to initiate this phase 1b trial by July 2006," president and chief executive officer Harry Palmin said in the release.

Novelos Therapeutics, based in Newton, Mass., is a biotechnology company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis.

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