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GlobeImmune Announces Presentation of Positive Interim Results From a Study of the GI-5005 Tarmogen in Patients With Chronic Hepatitis C Infection

Posted on: Monday, 30 October 2006, 09:00 CST

GlobeImmune, Inc. today announced positive interim results from Study GI-5005-01, a randomized, placebo-controlled, multi-center, dose-escalation, Phase 1b study of GI-5005 in patients chronically infected with hepatitis C virus (HCV). The data were presented today at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). GI-5005 generated cellular immune responses in 12/29 patients (41%), elicited a statistically significant improvement in alanine amino transferase (ALT) levels from baseline and caused near 1 log10 viral load reductions in three patients, two of whom had positive immune responses after only a three month course of GI-5005 monotherapy. No meaningful safety concerns were seen in the study to date.

"The interim results of this study appear to demonstrate a robust immunologic response in patients with chronic HCV," said Timothy C. Rodell, M.D., GlobeImmune's President and CEO. "To our knowledge, no other HCV therapy in development or on the market has shown the ability to convert the weak cellular immune response typically seen in chronically infected patients to a strong cellular response. The immune responses observed in chronically infected patients treated with GI-5005 resemble those of patients in the early stages of exposure to hepatitis C virus, during which a proportion of patients can spontaneously cure themselves. This suggests that GI-5005 has the potential to transform the immune activity of chronically infected patients into a more effective response and drive favorable clinical outcomes in the setting of chronic hepatitis C disease."

The purpose of the ongoing study is to evaluate the safety and preliminary efficacy of five weekly subcutaneous doses followed by two monthly subcutaneous doses of GI-5005 in ascending dose groups in patients chronically infected with hepatitis C virus. Patients that were treatment naive, partial responders, or relapsers to an interferon-based regimen with or without ribavirin were eligible for the study. Interim results on the first 40 subjects enrolled were presented in a poster at AASLD entitled: "Interim Results from a Randomized, Double-blind, Placebo-controlled Phase 1b Study in Subjects with Chronic HCV after Treatment with GI-5005, a Yeast-Based HCV Immunotherapy Targeting NS3 and Core Proteins."

The preliminary results of the study to date have demonstrated:

   1)  GI-5005 is well tolerated with no serious adverse events (SAEs),       dose limiting toxicities (DLTs), and no discontinuations due to       adverse events (AEs) to date.   2)  GI-5005 converted subjects with a weak cellular immune response       typical of chronic HCV patients to a strong cellular immune response       with broad HCV epitope coverage, consistent with the immune response       seen in patients during the acute stage of infection.   3)  The immune responses were observed in association with favorable       changes in viral load and ALT:           a.  A statistically significant difference in maximum change in               ALT (a surrogate of hepatic injury) from baseline in all               GI-5005 treated subjects compared to placebo treated               subjects (p=0.03).           b.  Three treated patients had viral load reductions approaching               1 log10 (0.75 log10 - 0.90 log10); no placebo patients had               HCV RNA reductions > 0.65 log10. 

About Hepatitis C

Chronic hepatitis C infection, a viral liver disease, is a major health epidemic. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, four million live in the United States, with an additional five to ten million in Western Europe. Approximately 20-30% of all hepatitis C patients will face life-threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma (primary liver cancer) and 30% of liver transplants in the United States. Currently, 8,000 to 10,000 deaths each year are attributed to hepatitis C.

About GI-5005

The GI-5005 Tarmogen(TM) (targeted molecular immunogen) is a whole, heat-killed recombinant Saccharomyces cerevisiae yeast engineered to express a hepatitis C virus fusion protein comprised of large segments of NS3 protease and Core protein sequences. Tarmogens are believed to activate both an innate immune response via Toll-like receptors (TLRs), as well as an adaptive, antigen specific cellular immune response.

About GlobeImmune, Inc.

GlobeImmune is a biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapy products called Tarmogens for the treatment of cancer and infectious diseases. The Company's lead product, GI-5005, a Tarmogen for the treatment of chronic hepatitis C infection, is currently in a placebo-controlled, Phase 1b human clinical trial. GI-4000, a Tarmogen for the treatment of various Ras-mediated cancers, is in a randomized, placebo-controlled, multi-center Phase 2 trial for the treatment of patients with early-stage pancreas cancer.

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, progress and results of the Company's clinical trial programs. 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.

 GLOBEIMMUNE CONTACT:  Kirk Christoffersen Senior Director, Corporate Development GlobeImmune, Inc. T: 303-625-2700 C: 303-775-7666 Contact via http://www.marketwire.com/mw/emailprcntct?id=B7E1B1A617C4139F  MEDIA RELATIONS CONTACT:  Dan Budwick BMC Communications Group, LLC T: 212-477-9007 x14 Contact via http://www.marketwire.com/mw/emailprcntct?id=76AAB32210A4E9EF  

SOURCE: GlobeImmune, Inc.

Source: MARKET WIRE

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