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Antivirals Combined Without Interferon: New Trial

HCV May Be Able to Be Cleared from Both Blood and Liver

The Editors at Hepatitis Central
November 12, 2008

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Viral clearance doubled in a Hepatitis C Phase II trial during standard therapy when coupled with GlobeImmune’s GI-5005. Because Hepatitis C must be eradicated not just from the blood, but also the liver, GI-5005’s ability to speed the clearance rate of infected cells from the liver shows great therapeutic promise.

GlobeImmune Hepatitis C Therapeutic Vaccine, GI-5005, Doubles Viral Clearance and Increases RVR Rates in Phase 2 Clinical Trial

Four-Week Data Comparing GI-5005 Plus Standard of Care vs. Standard of Care to Be Presented Next Week in Late-Breaking Poster at AASLD Meeting; AASLD President Will Highlight Data at President’s Press Conference

LOUISVILLE, CO, Nov 01, 2008 (MARKET WIRE via COMTEX) — Four-week Phase 2 clinical trial data show that GI-5005, GlobeImmune’s hepatitis C virus (HCV) targeted molecular immunogen (Tarmogen(R)), doubled viral clearance overall and in all major subgroups and doubled the rapid virologic response (RVR) rate in naive patients with high viral load. The study compared GI-5005 plus standard of care (SOC) — pegylated-interferon plus ribavirin — versus SOC alone in patients with chronic genotype 1 hepatitis C infection.

The study data will be presented by principal investigator John G. McHutchison, M.D., of Duke University, in a late-breaking poster next week at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Treatment-naive patients with high viral loads at baseline ( > 600,000 IU/mL) saw a 2.6-fold improvement in RVR, which is defined as undetectable HCV RNA levels ( < 25 IU/ml) by four weeks. Treatment-naive patients with a high viral load at baseline are particularly difficult to treat to an RVR. RVR is highly predictive of whether a patient will achieve a sustained virologic response (SVR), or “cure,” which is defined as undetectable HCV RNA at six months post-treatment. A significant improvement was also noted in the rate of viral reduction in the peripheral blood using viral kinetic analysis in all patients, with a 2-fold improved slope (0.32 log10/month difference, p=0.02) for patients receiving GI-5005 in addition to SOC. Comparable magnitude of increased viral clearance in GI-5005 treated patients was noted in all patient subgroups including prior non-responders and patients with high viral load at baseline.

“These data represent early but important evidence that a patient’s natural immune response can be harnessed to positively influence important virologic endpoints with the potential to impact the course of chronic HCV infection,” said Dr. McHutchison. “The rational combination of novel immune approaches such as GI-5005 with IFN-based standard of care or with novel direct acting antiviral agents holds promise in terms of ultimately improving clinical outcomes, shortening the exposure to toxic therapies, or both.”

David Apelian, M.D., Ph.D., GlobeImmune Chief Medical Officer, said, “These data indicate that GI-5005 can increase the rate of clearance of infected cells from the liver, something that interferon-based therapies and antivirals are not designed to do. Direct acting antivirals act primarily by inhibiting viral replication, an important step, but they have not been shown to speed the immune clearance of infected cells from the liver. Ultimately, to achieve sustained virologic response, HCV must be eradicated not just from the blood, but also the liver. GI-5005 may improve this critical part of the treatment and healing process in a way that is complementary to standard of care and the new direct acting antivirals.”

An HCV-targeted cellular immune response is essential to curing a patient with hepatitis C. Twenty percent of patients infected with hepatitis C have immune responses strong enough to clear the virus on their own, without medical intervention. However, for the remaining 80 percent who go on to develop chronic infection, it takes the immune system six to twelve months to eliminate the infection, even with SOC and the best antivirals. Improving the rate of viral clearance may ultimately lead to a decrease in the time needed for therapy.

“The role of the immune response in combating hepatitis C infection is often overlooked,” added Apelian. “Most of the recent development interest has been focused on new direct-acting antivirals, which inhibit viral replication. However, to improve the rate of viral clearance from the liver, it is necessary to stimulate an HCV targeted cellular immune response. We believe that the Phase 2 data to date demonstrate the potential of GI-5005 to be an important and complementary part of the treatment of hepatitis C.”

The GI-5005-02 clinical trial is a randomized, multi-center, Phase 2 study evaluating 140 patients, all with genotype 1 HCV infection. In the trial, 74 percent of the patients had never received prior treatment, and the remaining 26 percent experienced prior treatment failures.

GlobeImmune’s GI-5005 is a targeted molecular immunogen (Tarmogen(R)) designed to elicit an HCV-specific T-cell response. Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that express antigens from one or more disease-related proteins.

About GlobeImmune

GlobeImmune Inc. is a private company developing targeted molecular immunogens, Tarmogens(R), for the treatment of cancer and infectious diseases. The company’s lead product candidate, GI-5005, is a Tarmogen for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The company’s lead oncology program, GI-4000, targets mutated versions of the Ras oncoprotein for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer.

For additional information, please visit the company’s Web site at www.globeimmune.com.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company’s clinical trial programs and the preliminary results from the clinical trials. 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 the release and anticipated presentation.

SOURCE: GlobeImmune, Inc.

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