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news.Novelos Therapeutics, a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, has enrolled the first patient in a US Phase 2 trial evaluating NOV-205 as monotherapy in up to 40 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin.
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NOV-205 is an injectable, small-molecule proprietary formulation of oxidised glutathione and inosine that acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties.
The ongoing US Phase 2 trial aims to expand the safety database for NOV-205 and assess its effects on the same efficacy-related endpoints using a comparable dosing regimen, although this trial is being conducted in a more difficult to treat interferon/ribavirin non-responder patient population.
Raymond Koff, expert medical advisor for hepatitis at Novelos, said: “The safety data from the US Phase 1b short-term dosing trial support initiation of this Phase 2 trial, evaluating both dose escalation and extended dosing with NOV-205. Because NOV-205 is not a direct anti-viral agent, we believe the Phase 2 trial is more likely to demonstrate clinical activity.
“We look forward to further evaluating the clinical activity of NOV-205 in chronic hepatitis C non-responders – a large patient population for which there is no established, beneficial therapy.”