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Antiviral activity seen at all dose levels tested
Results support moving to dose-ranging Phase II studies in
treatment-nave HCV patients
PRINCETON, N.J. & SEATTLE(BUSINESS WIRE)
Bristol-Myers
Squibb Company (NYSE: BMY) and ZymoGenetics,
Inc. (NASDAQ: ZGEN) today presented final results from a Phase 1b
clinical trial of PEG-Interferon lambda administered with ribavirin in
relapsed and treatment-nave hepatitis C virus (HCV) patients. The
poster included data on 56 patients in the study. Antiviral activity was
observed at all dose levels tested. The results will be presented at the
American Association for the Study of the Liver Diseases annual meeting
in Boston on November 3. Interim results were previously presented at
the European Association for the Study of the Liver annual meeting in
April 2009.
There is a strong need for additional options for hepatitis C
patients,? said Brian Daniels, M.D., senior vice president, Global
Development & Medical Affairs, Bristol-Myers Squibb. We are pursuing
this investigational pathway to address the fact that although current
interferons have been the backbone of therapy with meaningful efficacy,
they are often poorly tolerated, leading to dose reductions, poor
compliance and avoidance of treatment.?
We are excited about the prospects for PEG-Interferon lambda as a
potential HCV treatment,? said Eleanor L. Ramos, M.D., senior vice
president and chief medical officer of ZymoGenetics. There is a clear
unmet medical need for an interferon with improved safety and
tolerability. We look forward to obtaining additional clinical data on
this promising investigational medicine.?
The Phase 1b clinical trial was designed to evaluate the safety and
antiviral activity of PEG-Interferon lambda when given as a single agent
or in combination with ribavirin in genotype 1 HCV patients with
relapsed disease and in treatment-nave patients.
In the single agent arm of the study with treatment-relapsed patients
(n=24), PEG-Interferon lambda was administered subcutaneously at 1.5
mcg/kg and 3.00mcg/kg weekly for four weeks, and 1.5 mcg/kg and 3.00
mcg/kg every two weeks. In the combination arm of the study with
treatment-relapsed patients (n=24), PEG-Interferon lambda was
administered subcutaneously weekly at 0.5 mcg/kg, 0.75 mcg/kg, 1.5
mcg/kg and 2.25 mcg/kg for four weeks, with daily oral ribavirin
administered consistent with the package insert. Patients in the cohort
of treatment-nave patients (n=7) were given 1.5 mcg/kg of
PEG-Interferon lambda and ribavirin.
PEG-Interferon lambda demonstrated antiviral activity at all dose levels
tested in both relapse and treatment nave HCV patients. A majority of
patients across all treatment arms achieved a greater than 2 log
reduction in HCV RNA.
Of the patients in the single agent arm of the study, all 12 of those
patients receiving 1.5 mcg/kg and 3.0mcg/kg weekly for four weeks
achieved a greater than 2 log decrease in HCV RNA. Five of the 12
patients receiving 1.5 mcg/kg and 3.00mcg/kg every two weeks for four
weeks achieved a greater than 2 log decrease in HCV RNA.
At PEG-Interferon lambda doses of 0.75 mcg/kg, 1.5 mcg/kg and 2.25
mcg/kg administered in combination with ribavirin in treatment-relapsed
patients (n=18), a greater than 3 log mean maximum decrease in viral
load was observed. Of those patients, eleven (61%) had less than 1,000
HCV RNA copies at Day 29.
Treatment-naive patients, who were treated with 1.5 mcg/kg of
PEG-Interferon lambda in combination with ribavirin (n=7), also had a
greater than 3 log mean maximum decrease in viral load and two patients
(29%) achieved a rapid virologic response (RVR), or undetectable HCV RNA
copies, at 4 weeks.
The most common adverse events were fatigue (29%) and nausea (13%).
There were minimal effects on neutrophil counts. Minimal constitutional
symptoms or hematologic effects were observed with PEG-Interferon lambda
given as a single agent or in combination with ribavirin. The majority
of adverse events and laboratory changes were grade 1 or 2.
Dose-limiting elevations in ALT or AST, with or without an increase in
bilirubin, were dose-dependent and reversible.
Overall, the results of the study support moving to dose-ranging Phase 2
studies in treatment-nave HCV patients.
About Interferon lambda
Interferon lambda (IL-29) is a type 3 interferon that binds to a unique
receptor with more restricted distribution than the receptors targeted
by type 1 interferons, such as interferon alpha. It is in development
for hepatitis C. The native human protein Interferon lambda is generated
by the immune system in response to viral infection. IL-29 is a member
of the type 3 Interferon family, which includes IL-28A and IL-28B, and
signals through the same receptor as IL-28A and IL-28B.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to
discovering, developing and delivering innovative medicines that help
patients prevail over serious diseases. For more information, please
visit www.bms.com.
About ZymoGenetics
ZymoGenetics is focused on the creation of novel protein drugs to
improve patient care and address unmet medical needs. The company's
strategy is to discover, develop and commercialize its products
independently, in collaboration with partner companies or through
out-licensing. ZymoGenetics developed and markets RECOTHROM
Thrombin, topical (Recombinant), a synthetic version of a human
blood-clotting enzyme used to stop bleeding during surgery. The company
is developing a proprietary portfolio of immune-based product
candidates. PEG-Interferon lambda is a novel type-3 interferon in
clinical development for the treatment of chronic hepatitis C infection.
Interleukin-21 is a novel cytokine in clinical development for the
treatment of metastatic melanoma and renal cell carcinoma. Several other
proprietary product candidates are in preclinical development. In
addition, ZymoGenetics has licensed rights to multiple clinical and
preclinical drug candidates being developed by other companies. For
further information, visit www.zymogenetics.com.
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 December 31, 2008, its Quarterly Reports on
Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events, or
otherwise.
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 ZymoGenetics. These statements
are not guarantees of future performance and involve risks and
uncertainties that are difficult to predict. ZymoGenetics' actual
results and the timing and outcome of events may differ materially from
those expressed in or implied by the forward-looking statements because
of risks and uncertainties associated with clinical development. For
example, the results of preliminary studies do not predict clinical
success, and larger and later-stage clinical trials may not produce the
same results as earlier-stage trials. In addition, the
forward-looking statements in this press release are subject to the
other risks detailed in the company's public filings with the Securities
and Exchange Commission, including the company's Annual Report on Form
10-K for the year ended December 31, 2008 and Quarterly Report on Form
10-Q for the quarter ended June 30, 2009. Except as required by law,
ZymoGenetics undertakes no obligation to update any forward-looking or
other statements in this press release, whether as a result of new
information, future events or otherwise.
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
or
ZymoGenetics
Media
and Investors
Susan W. Specht, 206-442-6592
spechts@zymogenetics.com
Source: Bristol-Myers Squibb Company
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