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news.The FDA has accepted Novelos Therapeutics investigational new drug application which seeks approval for the company to begin human testing of its hepatitis C candidate, NOV-205.
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The initial US-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 – the current standard of care for the disease.
NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. The drug has already approved regulatory approval in the Russian Federation 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. NOV-205 was well-tolerated in these studies.
The US-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.
“This is another significant and fundamental milestone for Novelos,” said Harry Palmin, president and CEO of Novelos. “In addition to being a phase III cancer company with NOV-002, Novelos has now commenced a US 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 Ib trial by July 2006.”