ZymoGenetics Announces Completion of Enrollment in Phase 2b Clinical Trial with PEG-Interferon lambda in Hepatitis C

ZymoGenetics Announces Completion of Enrollment in Phase 2b Clinical Trial with PEG-Interferon lambda in Hepatitis C

press release


Aug. 25, 2010

Phase 1b study of pegylated interferon lambda 1 with or without ...
Interferon lambda 1 (IFN-λ1) is a type III IFN that produces intracellular responses similar to those of IFN-α but in fewer cell types because of ...
www.natap.org/2010/HCV/080910_02.htm

A Phase 1b Dose-Ranging Study of 4 Weeks of PEG-Interferon (IFN ...
Nov 3, 2009 ... Background: PEG-IFN-lambda (PEG-IFN-λ) is a unique interferon that has fewer flu -like symptoms and hematologic adverse effects than are ...
www.natap.org/2009/AASLD/AASLD_20.htm

SEATTLE, Aug 25, 2010 (BUSINESS WIRE) -- ZymoGenetics, Inc. today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection. ZymoGenetics is investigating PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company for the treatment of HCV infection.


"We're very pleased to have completed the enrollment in the Phase 2b PEG-IFN lambda clinical trial in less than three months," said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "The rapid enrollment to this study speaks to the motivation and enthusiasm of the clinical trial investigators to help address the unmet medical need in hepatitis C and also to the outstanding execution by our clinical team. We should now be able to assess the primary endpoint earlier than originally projected, and we look forward to assessing the data and planning for Phase 3."


The Phase 2 EMERGE study is an international, randomized multi-center clinical trial with PEG-Interferon lambda and ribavirin in treatment-naive patients with HCV. The Phase 2b study enrolled 570 patients with genotypes 1, 2, 3 and 4 chronic HCV infection. The study is assessing the safety and antiviral efficacy of three doses of PEG-Interferon lambda (120 mcg, 180 mcg and 240 mcg) compared to PEGASYS(R). Weekly subcutaneous doses of PEG-Interferon lambda or PEGASYS are being administered for 48 weeks in genotype 1 and 4 patients and for 24 weeks in genotype 2 and 3 patients. All patients 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 (complete Early Virological Response). Achievement of Early Virologic Response will also be assessed by patient IL-28B genotype, which has been shown to be a robust predictor of treatment success with the combination of interferon-alpha and ribavirin.


PEG-Interferon lambda


PEG-Interferon lambda (IL-29) is a novel interferon in development for hepatitis C. The native human interferon lambda proteins are generated by the immune system in response to viral infection, and signal through a different receptor than type I interferons, such as interferon alpha. Because this receptor is present on fewer cell types within the human body, it is hypothesized that PEG-Interferon lambda may be able to demonstrate an improved safety and tolerability profile compared to alpha interferons.


About ZymoGenetics


ZymoGenetics is a biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the treatment of human diseases. The company has developed and is marketing RECOTHROM(R) Thrombin, topical (Recombinant) in the United States. ZymoGenetics has two product candidates in Phase 2 clinical development: PEG-Interferon lambda, being studied in collaboration with Bristol-Myers Squibb for treatment of hepatitis C virus (HCV) infection, and IL-21, being tested as a potential treatment for metastatic melanoma. In addition, ZymoGenetics has an anti-IL-31 monoclonal antibody in preclinical development, which it expects to test initially as a treatment for atopic dermatitis. Several of the product candidates previously identified through ZymoGenetics' discovery research efforts have been licensed to and are being developed by third parties, including Merck Serono and Novo Nordisk. ZymoGenetics is eligible to receive milestone payments and royalties related to these assets. For further information, visit www.zymogenetics.com.


ZymoGenetics Forward-Looking Statements


This press release contains forward-looking statements, including statements related to conducting and analyzing the results of clinical trials. Words such as "believes," "should" and "could" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ZymoGenetics' current expectations and involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to ZymoGenetics' ability to design and conduct clinical trials, the possibility that clinical trial results may vary between different arms of a clinical trial and the difficulty of using prior clinical trial results to predict future outcomes, as well as those other risks detailed in ZymoGenetics' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2009 and periodic reports on Form 10-Q and current reports on Form 8-K. Do not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and, except where required by law, ZymoGenetics undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.


PEGASYS(R) (Peginterferon alfa-2a) is a registered trademark of Hoffman La Roche.


SOURCE: ZymoGenetics, Inc.


ZymoGenetics, Inc.

Susan W. Specht 206-442-6592