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ZymoGenetics Reports Positive Interim Results From Phase Ib Hepatitis Trial

Posted on: Tuesday, 4 November 2008, 09:00 CST

ZymoGenetics, a developer of therapeutic proteins for treatment of human diseases, has reported that PEG-Interferon lambda showed a meaningful reduction in the amount of hepatitis C virus and was well tolerated in patients with relapsed HCV in an ongoing Phase Ib clinical trial.

The Phase Ib clinical trial is evaluating the safety and anti-viral activity of PEG-Interferon lambda in genotype 1 hepatitis C virus (HCV) patients with relapsed disease. To date, in the single agent part of the study, PEG-Interferon lambda has been administered subcutaneously either with a weekly or biweekly schedule at doses of 1.5mcg/kg or 3mcg/kg for four weeks.

According to the company, anti-viral activity was seen in all cohorts, with the best anti-viral effect documented at 1.5mcg/kg given weekly. All six patients treated in this cohort showed a 2 log or greater decrease in viral load at day 29, with four of these patients having less than 1,000 HCV RNA copies at the end of treatment.

PEG-Interferon lambda was well tolerated at all dose levels, with no discontinuations due to toxicity, no treatment-related fever, no signs of hematological toxicity and no meaningful changes in hematological parameters.

Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: "PEG-Interferon lambda has become one of our company's key assets. Based on these early results, we're encouraged by the potential for PEG-Interferon lambda to become an effective treatment with improved tolerability for treating patients with hepatitis C. We've accelerated the timeline for the second part of the study, where the combination of PEG-Interferon lambda and ribavirin will be investigated."

Source: Datamonitor

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