Hepatitis C Therapy

Novelos Therapeutics files IND with U.S. FDA for novel hepatitis C drug

Published in Medical Letter on the CDC and FDA, April 19th, 2006

Novelos Therapeutics, Inc. (NVLT) announced that it has filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) for NOV-205, its second clinical stage compound, 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.

NOV-205...

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Source: Medical Letter on the CDC and FDA (2006-04-19)

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