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news.Biotech firm Novelos Therapeutics has filed an investigational new drug application with the FDA for its experimental chronic hepatitis C treatment, NOV-205. If the application is approved the company will be able to begin testing the compound in human trials in the US.
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If given the go-ahead, the initial US based trial will evaluate NOV-205 as monotherapy for chronic hepatitis C patients who have failed pegylated interferon plus ribavirin therapy.
NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity. 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 and significantly improved abnormal liver enzyme values.
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 us,” 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 mid-2006.”