October 28, 2010

GlobeImmune Expands GI-5005-02 Phase 2b Trial to Include Additional Treatment Naive IL28B T/T Subjects With Chronic Genotype 1 HCV

By: Marketwire
Oct. 28, 2010 08:00 AM

LOUISVILLE, CO -- (Marketwire) -- 10/28/10 -- GlobeImmune Inc. today announced the expansion of its Phase 2b clinical trial of GI-5005, an investigational Tarmogen product for the treatment of hepatitis C virus (HCV) infection. The Company previously reported data demonstrating a 60% improvement in sustained virologic response (SVR) in chronically infected HCV patients with the hardest-to-treat IL28B T/T genotype when GI-5005 was added to standard of care (SOC) versus SOC alone (60% vs. 0% SVR). The Company plans to enroll 40 additional subjects with the IL28B T/T genotype. Approximately 20% of chronically infected HCV patients have the IL28B T/T genotype, and those patients are least likely to respond to treatment with SOC. Data from the additional 40 subjects will allow for more precise powering of pivotal clinical trials.

"HCV patients with the IL28B T/T genotype have a very poor prognosis with current treatment options," said Timothy C. Rodell, M.D., President and CEO of GlobeImmune. "We believe that GI-5005 addresses a fundamental deficit in patients carrying the T allele of the IL28B gene by augmenting their deficient T cell immune response against HCV. Our phase 2 immunology data indicate that a limited T cell immune response is likely why the current standard of care, which acts primarily by inhibiting viral replication, has limited efficacy in this patient group."

"Patients with the IL28B T/T genotype have the lowest rates of sustained virologic response to today's standard of care and will very likely continue to have lower response rates and a high rate of anti-viral resistance with the addition of a protease inhibitor," said Mitchell L. Shiffman, M.D., Director of The Liver Institute of Virginia. "Preliminary data strongly suggest that GI-5005 enhances the ability of a patient with the IL28B T/T genotype to respond to HCV treatment. This represents the first significant advance in our ability to treat chronic HCV in patients who are genetically less sensitive to interferon. The expansion of the GlobeImmune program to specifically study patients with the IL28B T/T genotype is an important step for successful treatment of these patients in the future."

Additional data from the original 140 subjects enrolled in the trial will be presented this week at 61st Annual Meeting of the American Association for the Study of the Liver (AASLD) in Boston.
  • Paul J. Pockros, M.D. of Scripps Clinic will deliver an oral presentation of the results from the GI-5005-02 trial in patients previously treated with SOC in a late-breaker session Monday November 1, 2010 at 6 p.m. EDT in the Hynes Auditorium.
  • John M. Vierling, M.D. of Baylor College of Medicine will present immune response data in a poster on Tuesday November 2, 2010 Hynes Exhibit Hall C. 
The design of the clinical trial expansion is identical to the original GI-5005-02 trial, and will be conducted in approximately 30 of the participating U.S. sites. The primary endpoint of the randomized, open-label expansion study is sustained virologic response (SVR).

Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that are engineered to express 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 are designed 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 http://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.


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