GlobeImmune Announces Completion of Planned Enrollment for GI-5005-02 Phase 2 Trial in Chronic Hepatitis C Patients

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Tue May 20, 2008 4:01pm EDT

  LOUISVILLE, CO, May 20 (MARKET WIRE) -- 
 GlobeImmune, Inc. announced today completion of the planned enrollment of 120
subjects in a Phase 2 clinical trial to evaluate the GI-5005 Tarmogen(R) for
the treatment of patients with chronic hepatitis C infection. GI-5005 is being
evaluated as a potential therapy in combination with standard of care;
pegylated interferon plus ribavirin.

    The Phase 2 clinical trial is a randomized, open-label, multi-center trial
evaluating GI-5005 in combination with full duration standard of care, versus
standard of care alone in patients with chronic genotype 1 hepatitis C infection
who are either treatment-naive or non-responders to previous therapy.  Endpoints
for the trial include improvement in early virologic response (EVR), HCV RNA
kinetics, alanine aminotransferase (ALT) levels, the primary biochemical marker
of liver damage, end of treatment response (ETR), sustained virologic response
(SVR), serum markers of liver fibrosis / necrosis, and liver biopsy.  This study
has enrolled the planned target of 120 patients in five months at 40 centers in
the U.S., India and Europe.

    About GI-5005

    GI-5005 is GlobeImmune's lead infectious disease product candidate for the
treatment of chronic hepatitis C infection.  GI-5005 is whole, heat-killed
recombinant yeast genetically modified to express HCV-specific protein targets. 
The mechanism of action for GI-5005 (i.e. T cell-mediated elimination of
infected
hepatic cells) may work synergistically in combination with the current or
emerging standard of care, which directly inhibits viral replication, to more
effectively eradicate hepatitis C virus from the liver.  Additionally, this
mechanism of action may offer an option for interferon-intolerant or
interferon-contraindicated patients as a long term monotherapy.

    About Hepatitis C Infection

    The World Health Organization (WHO) estimates that 170 million people
globally
are infected with Hepatitis C virus (HCV), with 3-4 million new infections
each year.  Roughly 80-90% of these cases fail to resolve acutely and evolve
into
a chronic state.  The population of subjects with chronic HCV infections is
estimated at approximately 4 million cases in the U.S. and 5-10 million in
Europe.  Of the 4 million subjects infected in the U.S., only 20-40% are
estimated to be currently diagnosed given the largely asymptomatic nature of HCV
infection.  The current standard of care for genotype 1 HCV patients, the
most common subtype in the U.S., is 48 weeks of pegylated interferon plus
ribavirin.  This treatment is often poorly tolerated and only results in cure
rates (sustained virologic response) of approximately 50%.

    About GlobeImmune, Inc.

    GlobeImmune is a private Colorado-based company developing active
immunotherapies called Tarmogens for the treatment of cancer and
infectiousdiseases.   The Company's lead product candidate, GI-5005, is a
Tarmogen being
developed for the treatment of chronic hepatitis C infection.  The Company
has completed enrollment of a randomized Phase 2 trial of GI-5005 in combination
with the current standard of care.  GI-5005 is designed to complement both
the current and emerging standard of care for hepatitis C infection through
the direct elimination of chronically infected cells. The Company's lead
oncology program, GI-4000, is designed to be a treatment for cancers of the lung
and gastrointestinal tract.  A randomized, placebo-controlled Phase 2 trial in
patients with resectable pancreas cancer in combination with adjuvant
gemcitabine
is ongoing.  Additionally, a Phase 2 trial in NSCLC subjects is ongoing at
Memorial
Sloan Kettering Cancer Center.

    For additional information, please visit the company's website at
www.globeimmune.com

    This press release contains forward-looking statements that involve risks
and
uncertainties, including statements relating to initiation and progress of the
Company's clinical trial programs and potential advantages of the Company's
technology and product candidates. Actual results could differ materially from
those projected and the Company cautions readers not to place undue reliance
on the forward-looking statements contained in this release.

    



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