News Release
Bristol-Myers Squibb and ZymoGenetics Present Positive 4-week Results of PEG-Interferon lambda with Ribavirin in Hepatitis C
April 24, 2009
“PEG-Interferon lambda showed antiviral effects as a single agent and
also in combination with ribavirin. The lack of hematologic adverse
effects in the trial is very encouraging,” said
The Phase 1b clinical trial was designed to evaluate the safety and antiviral activity of PEG-Interferon lambda as a single agent or in combination with ribavirin in genotype 1 HCV patients with relapsed disease. The single agent part of the study, designed to assess PEG-Interferon lambda administered subcutaneously either with a weekly or every other week dose-escalation schedule at 1.5 mcg/kg and 3.0 mcg/kg for four weeks, is complete. In the combination part of the study, data are available for the first 10 subjects who have received weekly subcutaneous administration of PEG-Interferon lambda at doses of 0.75 mcg/kg (3 patients) or 1.5 mcg/kg (7 patients) with daily oral ribavirin administered per the package insert over a four-week period.
Antiviral activity was seen in all cohorts, with a mean maximum decrease in HCV RNA viral load of at least 3.0 log10 in all single agent and combination cohorts receiving weekly dosing. Of the 22 patients dosed weekly, 86% showed a 2 log10 or greater decrease in HCV RNA at Day 29 and 50% had less than 1,000 HCV RNA copies. Of the six patients treated weekly with 3.0 mcg/kg single agent, 50% achieved a rapid virologic response (RVR; undetectable HCV RNA copies at 4 weeks).
PEG-Interferon lambda was well tolerated over four weeks of treatment with minimal hematologic effects or constitutional symptoms. No fever was reported. The majority of adverse events were Grade 1 or 2, the most common of which were fatigue (18%) and nausea (18%). Reversible, dose-dependent increases in liver enzymes (ALT, AST) meeting the protocol criteria for dose-limiting toxicity were observed in four patients, of which three also experienced reversible increases in bilirubin. There were no clinically significant changes in serum chemistry or renal function. Decreases in mean hemoglobin values occurred only in ribavirin cohorts, and there was no neutropenia.
|
Presentations |
| Two poster presentations will be given at the EASL 2009 Annual Meeting: |
|
Friday, April 24, 2009 |
| Time: 02:00 a.m. – 12:00 p.m. EDT |
| Poster Board #: 643 |
|
Title: PEG-IFN-λ: Antiviral Activity And Safety Profile In A 4-Week Phase 1B |
|
Study In Relapsed Genotype 1 Hepatitis C Infection |
|
Session Title: Category 5G: Viral Hepatitis – g Hepatitis C – Clinical (Therapy) |
|
Saturday, April 25, 2009 |
| Time: 02:00 a.m. – 12:00 p.m. EDT |
| Poster Board #: 942 |
|
Title: Viral Kinetic Modeling During Treatment With Interferon Lambda-1A In |
|
Genotype 1 Chronic Hepatitis C Patients |
|
Session Title: Category 5H: Viral Hepatitis – h Hepatitis C – Clinical (New |
|
Compounds, Resistance) |
|
The EASL poster presentations will be made available on the ZymoGenetics website at www.zymogenetics.com. |
PEG-Interferon lambda
PEG-Interferon lambda (IL-29) is a novel type 3 interferon currently in Phase 1b development for hepatitis C. The native human protein Interferon lambda is generated by the immune system in response to viral infection.
About Hepatitis C1
Hepatitis C is a virus that infects the liver and is transmitted through
direct contact with blood. An estimated 170 million people worldwide are
infected with hepatitis C and, of these, 94.5 million people live in the
About
About
Bristol-Myers Squibb Forward-Looking Statements
This press release contains “forward-looking statements” as that term
is defined in the Private Securities Litigation Reform Act of 1995,
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change any
of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks, there can be no
guarantee that the compound described in this release will move from
early stage development into full product development, that clinical
trials of this compound will support a regulatory filing, or that the
compound will receive regulatory approval or become a commercially
successful product. Forward-looking statements in the press release
should be evaluated together with the many uncertainties that affect
Bristol-Myers Squibb’s business, particularly those identified in the
cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on
Form 10-K for the year ended
ZymoGenetics Forward-Looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on the current intent and
expectations of the management of
References
1.
Source:
ZymoGenetics
Media and Investors:
Susan W. Specht,
206-442-6592
spechts@zymogenetics.com
or
Media
and Investors:
Michael Fitzpatrick, 206-442-6702
fitzpatm@zymogenetics.com
or
Bristol-Myers
Squibb
Media:
Jennifer Fron Mauer, 609-252-6579
jennifer.mauer@bms.com
or
Investors:
John
Elicker, 609-252-4611
john.elicker@bms.com
*****************************************
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding ZymoGenetics Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.