1. A favorable safety profile with the dose escalation to the highest
planned dose without dose limiting toxicity. Safety findings were
generally limited to transient local injection site reactions and
transient mild constitutional complaints.
2. Strong trends for a dose dependent response in the percent of patients
that normalize their ALT (a marker of liver damage) compared with
placebo, ranging from no normalizations in the placebo group up to 50%
of the patients in the highest dose group (40YU).
3. Viral load reductions (nadir) in six treated patients ranging from
-0.75 log10 to -1.4 log10. Viral load reductions were achieved with
only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral
therapy.
4. Biologic / immune activity by converting patients from an immune
response profile associated with chronic infection to one similar to
patients who clear the virus naturally during the acute phase as
measured by ELISpot assay.
5. No placebo patients had near log10 reductions of viral load or
demonstrated an immune response by ELISpot assay.
"These results indicate that a short course of GI-5005 alone is capable of
generating an HCV specific immune response that is associated with improved
liver inflammation and clearance of infected hepatic cells. We find this
particularly encouraging since these patients were not treated with
concurrent anti-viral therapy; we expect that an immune-based therapy, such
as GI-5005, would complement current standard of care or future
anti-virals," said David Apelian, M.D., Ph.D., Chief Medical Officer of
GlobeImmune. "A Phase 2 trial comparing GI-5005 plus pegylated interferon
plus ribavirin versus pegylated interferon plus ribavirin alone is now
being initiated at 50 centers in the United States, EU, and India.
Long-term GI-5005 salvage therapy will also be examined in this trial in
patients who fail to achieve an early virologic response (EVR) or do not
tolerate treatment in the pegylated interferon/ribavirin arm."
About GI-5005
GI-5005 is GlobeImmune's lead infectious disease product from its
proprietary Tarmogen active immunotherapy platform 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. immune 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. A
randomized Phase 2 study evaluating GI-5005 plus standard of care
(pegylated interferon plus ribavirin) versus standard of care alone is
planned to begin in the fourth quarter of 2007.
About Hepatitis C Infection
The World Health Organization (WHO) estimates that 170 million people
globally are infected with hepatitis C virus (HCV) with three to four
million new infections each year. Roughly 80-90% of these cases fail to
resolve acutely and evolve into a chronic state. The population of
patients with chronic HCV infections is estimated at approximately four
million cases in the United States and five to ten million in Europe. Of
the four million patients infected in the United States, 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 United States, 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 infectious
diseases. The Company's lead product candidate, GI-5005, is a Tarmogen
being developed for the treatment of chronic hepatitis C infection that has
completed Phase 1b clinical trials. 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 has
initiated a randomized, placebo-controlled Phase 2 study of GI-5005 in
combination with standard of care for chronic hepatitis C infection. 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.
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. Actual results could differ materially from those
projected and the Company cautions investors not to place undue reliance on
the forward-looking statements contained in this release.
Contact Information: GLOBEIMMUNE CONTACT: Timothy C. Rodell, M.D. President & Chief Executive Officer GlobeImmune, Inc. phone: 303-625-2700 MEDIA CONTACT: Brad Miles BMC Communications Group phone: 212-477-9007 ext 17