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PRESS RELEASE
Wednesday, November 15 2005
Company Press Release
SOURCE: : Intarcia Therapeutics, Inc.
Intarcia Therapeutics Announces Interim Results From A Phase 2
Study Of Omega Interferon In Hcv
-Data Presented at AASLD Shows Robust Antiviral Activity-
-Results Support Further Development of Omega DUROS®-
San Francisco, Ca., November 15, 2005 Intarcia
Therapeutics, Inc., a privately held, biopharmaceutical company,
today announced interim results from a Phase 2 study of omega
interferon with or without ribavirin in interferon-naïve
Genotype 1 chronic HCV patients. The results demonstrate that
omega interferon in combination with ribavirin is well tolerated
and shows robust antiviral activity as evidenced by an early viral
response (EVR) rate of 84%. The 12 week EVR data are being presented
today at the 56th annual meeting of the American Association
for the Study of Liver Diseases (AASLD) in San Francisco, California
by Professor Vladimir Gorbakov with the State Medical Institute
of Postgraduate Course, Ministry of Defense, Moscow, Russia.
This Phase 2 study of daily subcutaneous omega interferon injections
is providing Intarcia with safety and clinical response data in
support of further development of omega interferon delivered by
continuous release from the DUROS® device.
"These early data compare favorably with the published data
for alpha interferons and in particular support the use in combination
with small molecule antiviral agents such as ribavirin. We are
very excited about these results so far," said Peter
Langecker, M.D., Ph.D., Chief Medical Officer and Vice President
of Clinical Research at Intarcia.
Alice Leung, Chief Executive Officer of Intarcia stated, "We
are developing omega interferon to improve the treatment of HCV
by offering a more convenient, potentially safer and more efficacious
therapy. Based on the data so far, we believe that a continuous
release formulation of omega interferon has the potential to become
an important therapy for HCV patients."
The ongoing Phase 2 trial is evaluating omega interferon alone
and omega interferon in combination with ribavirin in 102 interferon-naïve
patients with Genotype 1 chronic HCV infection. This is an open-label,
multi-center, active-controlled study conducted in Moscow, Russia.
Patients are receiving daily injections of omega interferon (25
mcg) administered by study personnel for up to 48 weeks in order
to approximate omega interferon blood levels anticipated from
omega DUROS®. The endpoints for this clinical trial
are EVR, defined as a 2-log reduction in HCV RNA after 12 weeks
of treatment, and sustained viral response rate (SVR), defined
as undetectable HCV RNA six months after the end of 48 weeks of
treatment. Overall, EVR has been observed in 84% (56/67) of the
patients on omega interferon with ribavirin, 60% (21/35) of the
patients on omega interferon alone and 75% (77/102) of the total
patients. In addition, 71 of the 77 patients (92%) of patients
with EVR had undetectable levels of virus in their blood determined
by the Roche AMPLICOR™ HCV assay at 12 weeks (lower
limit of quantification < 600 IU/mL). The rates of EVR and
undetectable HCV RNA in patients on omega interferon or omega
interferon plus ribavirin suggest a favorable therapeutic outcome.
SVR data, the other endpoint of the study, will be available by
the end of 2006.
With this study, Intarcia also took a step towards testing its
hypothesis that maintaining continuous drug levels through daily
administration of omega interferon may minimize side effects when
compared to other interferon therapies. This study to date has
shown that omega interferon is well tolerated with only two discontinuations
due to adverse events to date. Results of this ongoing Phase 2
study suggest a favorable overall safety profile with no substantial
safety issues being identified. Normalization of serum ALT a marker
of reduced liver inflammation occurred in 72.6% of patients receiving
omega interferon in combination with ribavirin and 53.3% of patients
receiving omega interferon alone.
About omega DUROS®
Omega DUROS® is being developed to improve the
treatment of HCV by offering a more convenient and potentially
safer and better therapy. Omega DUROS® is designed
to deliver a continuous and consistent dose of omega interferon
for three months via the implantable DUROS® device,
a drug delivery technology developed by ALZA Corporation and already
approved by the FDA for the treatment of patients with prostate
cancer.
About Hepatitis C
Hepatitis C is a major global public health problem. According
to the World Health Organization, more than 170 million people
worldwide are chronically infected with HCV, and three to four
million new HCV infections occur annually. The U.S. Centers for
Disease Control and Prevention has estimated that in the United
States approximately 2.7 million people are chronically infected
with HCV and approximately 25,000 patients are diagnosed each
year. It is estimated that 10,000 to 12,000 patients die annually
in the United States from complications resulting from HCV infection.
The current standard of care for treating chronic hepatitis C
is combination therapy consisting of pegylated interferon and
ribavirin.
About Intarcia
Intarcia Therapeutics Inc, a privately held pharmaceutical company,
is developing therapies for the treatment of cancer, immunological,
and infectious diseases. The company specializes in redirecting
the development of drugs to new indications which meet significant
unmet medical needs. The company has agreements with ALZA Corporation,
Boehringer Ingelheim, Chiron, Pfizer and Schering AG. Based in
Emeryville, California, the Company is privately held and backed
by premier investors, including Alta Partners, Brentwood Associates,
Delphi Ventures, InterWest Partners, New Enterprise Associates,
and Venrock Associates. More information about the company is
available at www.intarcia.com.
# # #
Contact: James Ahlers
Chief Financial Officer
Intarcia Therapeutics
510-652-2600 ext 235
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