GlobeImmune Announces Initiation of Phase II Clinical Trial of GI-5005 in Patients with Chronic Hepatitis C

LOUISVILLE, CO, USA | December 19, 2007 |
GlobeImmune, Inc. announced today the initiation of the Company’s Phase 2 clinical trial to evaluate 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-arm, 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 will include improvement in alanine aminotransferase (ALT) levels, early virologic response (EVR), end of treatment response (ETR), sustained virologic response (SVR), serum markers of liver fibrosis / necrosis and liver biopsy in a subset of patients. This study is designed to enroll 120 patients randomized 1:1 in the 2 arms at approximately 50 centers in the U.S., India and Europe. A majority of the centers will be based in the U.S.

“With the initiation of this trial, we continue to make excellent progress in advancing our GI-5005 development program,” said David Apelian, M.D., GlobeImmune's Chief Medical Officer. “Our clinical data to date have shown GI-5005 to have an excellent safety profile, to be capable of generating a robust immunologic response and to have the potential to provide clinical benefit to patients with chronic HCV. While the current standard of care and the newer class of small molecule inhibitors primarily act by inhibiting viral replication, we believe the immunogenicity generated by GI-5005 will improve the rate of immune clearance of infected liver cells, be complementary with treatments that inhibit viral replication and have the potential to favorably impact clinical outcomes.”

About GI-5005

GI-5005 is GlobeImmune’s lead infectious disease product for the treatment of chronic hepatitis C infection from the Company’s proprietary Tarmogen active immunotherapy platform. 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.

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 that has completed a Phase 1b clinical trial. 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.


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