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news.Novelos Therapeutics has concluded the initial US-based double-blind, placebo-controlled Phase Ib trial evaluating Nov-205 as monotherapy in chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin.
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Based on favorable safety data in this 14-dose trial with 18 subjects (12 treated with Nov-205 and six with placebo), Novelos plans to initiate a longer proof-of-concept trial in hepatitis C non-responders in the second half of 2008.
Raymond Koff, Novelos’s expert medical advisor for hepatitis, said: “We believe that the safety data from the Phase Ib trial support the initiation of a treatment regimen with Nov-205 that is more likely to result in demonstrable clinical activity as Nov-205 is not a direct antiviral agent. We look forward to evaluating Nov-205’s single agent activity in an extended dosing setting in chronic hepatitis C non-responders, a large patient population for which there is no established, beneficial therapy.”