GlobeImmune's Hepatitis C Product Candidate Improves End of Treatment Response in All IL-28 B Genotypes, With the Greatest Effect in the Hardest-to-Treat Patients

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SOURCE: GlobeImmune

Apr 19, 2010 07:00 ET

GlobeImmune's Hepatitis C Product Candidate Improves End of Treatment Response

in All IL-28 B Genotypes, With the Greatest Effect in the Hardest-to-Treat

Patients

IL-28 B Genotype Has Been Shown to Correlate Highly With Response to Pegylated

Interferon Plus Ribavirin Standard of Care

Data Showing Correlation of GI-5005 Therapeutic Vaccine Treatment Response and

IL-28 B Genotype Presented at 45th Annual Meeting of the European Association

for the Study of the Liver

LOUISVILLE, CO--(Marketwire - April 19, 2010) - GlobeImmune Inc. announced

Phase 2b data for GI-5005, the Company's investigational Tarmogen® product for

hepatitis C virus (HCV) infection, correlating GI-5005 treatment response rate

and IL-28 B genotype in patients with chronic HCV infection.

It was recently reported that variations in the human IL-28 B gene are

predictive of spontaneous clearance of HCV infection ( et al, Nature

2009), as well as response to treatment with standard of care, (SOC) pegylated

interferon alpha plus ribavirin (Ge et al, Nature 2009). In the IL-28 B T/T

genotypes, only a third as many patients respond to SOC as compared to the C/C

genotype. The GI-5005 Phase 2b study demonstrated that all IL-28 B genotype

subgroups receiving GI-5005 in addition to SOC saw an improvement in viral

clearance as measured by PCR at the end of treatment (ETR) compared to patients

receiving SOC alone. Patients with the hardest-to-treat T/T genotype in the

GI-5005 arm of the study saw the greatest improvement in sustained virologic

response (SVR -- defined as viral negativity 6 months off treatment and used to

define successful treatment), with a 60 percent treatment effect compared to SOC

alone. Patients carrying the T allele (form) (C/T or T/T) of the IL-28 B gene

are at high risk for treatment failure with SOC and represent approximately 65

percent of the treatment naïve population.

" Differences in the IL-28 B genotype determine how effectively a patient's

immune system responds against the HCV virus, " said G. McHutchison, M.D.,

Associate Director of the Duke Clinical Research Institute at Duke University

Medical Center, who presented the data on Saturday at the 45th Annual Meeting of

the European Association for the Study of the Liver (EASL). " The data from the

GI-5005 study are encouraging because there is a significant need for potential

new strategies for the hardest to treat IL-28 B genotype patients. "

Genetic analysis of the IL-28 B gene was performed retrospectively on 140

patients with chronic genotype 1 hepatitis C infection who were either treatment

naïve or prior non-responders as part of a Phase 2b study comparing GI-5005 plus

SOC versus SOC. The data show:

•GI-5005 improved viral clearance as measured by PCR in all IL-28 B genotypes

•100% (5/5) patients in the GI-5005 arm of the trial with the hardest-to-treat

T/T genotype achieved viral negativity on treatment during the study

•60% (3/5) of T/T genotype patients receiving GI-5005 went on to achieve SVR,

compared to 0% (0/5) of patients receiving SOC

" Prior publications on the IL-28 B gene and this study demonstrate the

importance of the immune response in HCV treatment, " said Apelian, M.D.,

Ph.D., chief medical officer at GlobeImmune. " These data suggest that a critical

component of the future of HCV treatment lies in immune-stimulating therapies

such as GI-5005. "

Dr. McHutchison and Ira M. son, M.D., Astor Distinguished Professor

of Medicine at NewYork-Presbyterian/Weill Cornell Medical Center, presented

additional data from the Phase 2b study at the conference. The data demonstrated

a 10 percent absolute improvement in SVR for treatment-naïve patients receiving

GI-5005 plus SOC versus SOC alone. Adding GI-5005 to SOC also resulted in a 67

percent relative improvement in the proportion of patients achieving

normalization of ALT levels, and a 39 percent relative improvement in biopsy

necroinflammatory scores, both measures of liver damage.

Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that express

antigens from one or more disease-related proteins. GlobeImmune's GI-5005

Tarmogen is a therapeutic vaccine product candidate that contains conserved HCV

proteins and is designed to generate an HCV specific T-cell response.

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 that 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

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.