ZGEN: To Receive $70M Milestone from Initiation of Phase 2 Hepatitis C Trial

ZymoGenetics, Inc. (ZGEN) announced the initiation of a Phase 2 clinical trial of PEG-Interferon lambda (IL-29) and ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) infection. The first patient has been dosed in the study, triggering a $70 million milestone payment to ZymoGenetics from Bristol-Myers Squibb Company ( BMY | Quote | Chart | News | PowerRating), pursuant to the terms of a previously announced collaboration agreement.

The EMERGE study is an international, randomized multi-center clinical trial that will enroll approximately 50 patients in the first, open label portion that will explore a wide range of doses to be tested in the second part of the study. The second part of the study is designed to enroll approximately 500 patients. Weekly subcutaneous doses of PEG-Interferon lambda will be administered for up to 48 weeks. The study will assess the safety and antiviral efficacy of PEG-Interferon lambda compared to PEGASYS(R). All patients will also receive daily ribavirin. The primary endpoint of the trial is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy (cEVR). Sustained virological response (SVR) defined as undetectable levels of HCV 24 weeks after treatment will also be assessed.

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