GlobeImmune's Hepatitis C Therapeutic Vaccine Combined With Standard of

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SOURCE: GlobeImmune, Inc.

Nov 02, 2009 08:00 ET

GlobeImmune's Hepatitis C Therapeutic Vaccine Combined With Standard of Care

Increases End of Treatment Response Rate by 15%

Phase 2b Data Presented at American Association for the Study of Liver Diseases

Meeting

LOUISVILLE, CO--(Marketwire - November 2, 2009) - GlobeImmune Inc. will present

Phase 2b data today at the 60th Annual Meeting of the American Association for

the Study of Liver Diseases (AASLD) demonstrating that GI-5005, the Company's

investigational Tarmogen® product for hepatitis C virus (HCV) infection,

increased the end of treatment response in genotype 1 interferon-naïve patients

to 74% when used in combination with standard of care (SOC), pegylated

interferon plus ribavirin, versus 59% for patients receiving SOC alone. The lead

author of the study, G. McHutchison, M.D., Associate Director of the Duke

Clinical Research Institute at Duke University Medical Center, will present the

data.

This ongoing Phase 2b study is designed to compare GI-5005 plus SOC versus SOC

alone in 140 patients with chronic genotype 1 hepatitis C infection who were

either treatment naïve or prior non-responders. On a modified intent-to-treat

basis (patients having received at least one dose of combination therapy),

treatment naïve patients receiving GI-5005 plus SOC as a triple therapy had an

end of treatment complete response rate (HCV RNA < 25 IU/mL by PCR assay at 48

weeks) of 74%, compared with an end of treatment response rate of 59% for

treatment naïve patients receiving SOC alone. The 15% treatment effect was also

observed on an intent-to-treat basis. Patients in the GI-5005 treatment arm

showed a nearly two-fold improvement in the proportion of patients achieving

normalization of alanine aminotransferase (ALT) levels, a marker used to assess

liver damage, compared to those receiving SOC alone. The most common adverse

events associated with GI-5005 were injection site reactions that were generally

mild and transient in nature. Discontinuation rates due to adverse events were

comparable between GI-5005 triple therapy (9.7%) and SOC alone (7.4%).

" The efficacy and safety data generated thus far in this trial are encouraging

and suggest a potentially important role for this compound in the treatment of

HCV, " said Dr. McHutchison.

" We believe a robust immune response is necessary to clear HCV infected cells

from the liver and these data suggest that stimulating a T-cell immune response

with GI-5005 can have a meaningful impact on patient outcomes, " said

Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. " Demonstrating that

this therapeutic vaccine increased the complete response rate by 15% in this

trial, without adding significant toxicities, represents an important scientific

and medical advance. "

The late-breaker poster (LB15) titled, " GI-5005 Therapeutic Vaccine Plus

Peg-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus

Peg-IFN/Ribavirin in Naive Genotype 1 Chronic HCV Patients " will be presented by

Dr. McHutchison at the AASLD Meeting today from 1:00 - 2:30 p.m. in the Hynes

Exhibit Hall C at the B. Hynes Convention Center in Boston.

The GI-5005-02 clinical trial is a randomized, multi-center, Phase 2 study

evaluating 140 patients, all with chronic 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 Tarmogen 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 active immunotherapies called

Tarmogens for the treatment of cancer and infectious diseases. Tarmogens

generate activated killer T cells intended to locate and eliminate cancer cells

and/or virally-infected cells. The Company's lead product candidate, GI-5005, is

a Tarmogen being developed 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 cancers caused by mutated versions of the Ras oncoprotein. GI-4000 is

being investigated in clinical trials for the treatment of pancreas cancer as

well as other cancers that contain mutated Ras, including non-small cell lung

cancer and colorectal cancer. In May 2009, the Company announced a global

partnership with Celgene focused on the discovery, development and

commercialization of multiple product candidates for the treatment of 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.