Novelos Therapeutics, a biotechnology company based in Boston, MA, has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for its new hepatitis C drug, NOV-205. This product is a potential treatment alternative for the approximately 50% of chronic hepatitis (HCV) patients who do not respond to standard pegylated interferon and ribavirin therapy. NOV-205 has already gone through clinical studies and received regulatory approval in Russia. Novelos hopes to replicate the positive results achieved in the Russian trials by demonstrating safety and efficacy in the U.S. It plans to begin a clinical trial for NOV-205 by mid-2006.
Source: Novelos news release dated March 22, 2006