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

LOUISVILLE, CO--(Marketwire - May 20, 2008) - GlobeImmune, Inc. announced today completion of the planned enrollment of 120 subjects in a Phase 2 clinical trial to evaluate the GI-5005 Tarmogen® 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-naïve 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 infectious diseases. 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.