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.”