Date and Time: Tuesday, November 6 from 8:00am to 12:30pm ET
Publication Number: 1304; Schiff et al.
Session Title: HCV: Clinical Trials and Therapeutic Developments
Room: Exhibit Hall C
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
subjects with chronic HCV infections is estimated at approximately four
million cases in the U.S. and five to ten million in Europe. Of the four
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 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