SOURCE: GlobeImmune, Inc.

GlobeImmune, Inc.

October 01, 2010 09:05 ET

GlobeImmune Announces Late-Breaker Oral Presentation of GI-5005 Prior Non-Responder Data at AASLD 2010 Meeting

Immunology Data Also to Be Presented in Poster Session

LOUISVILLE, CO--(Marketwire - October 1, 2010) -  GlobeImmune Inc. today announced that an abstract related to GI-5005, its Phase 2 investigational hepatitis C virus (HCV) product candidate, has been accepted for a late breaking oral presentation at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place October 29 through November 2, 2010, in Boston.

At the AASLD annual meeting, GlobeImmune will present end-of-study data, including sustained virologic response (SVR) rate from prior non-responders, from a Phase 2 clinical study investigating the safety and efficacy of GI-5005. The study compared GI-5005 plus peg-interferon (peg-IFN) and ribavirin, the current standard of care (SOC), versus SOC alone in patients with chronic type 1 hepatitis C infection. Prior non-responders were defined as those patients who did not achieve viral negativity by PCR after a minimum of 12 weeks of SOC. Patients that had achieved viral negativity by PCR during prior SOC but had relapsed during or after completion of SOC therapy were excluded from the study.

The abstract, titled "GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves Sustained Virologic Response Versus PEG-INF/Ribavirin in Prior Non-Responders With Genotype 1 Chronic HCV Infection," is published online at the AASLD Web site.

Dr. Paul J. Pockros of Scripps Clinic is the lead author of the abstract that will be presented as part of a late breaker oral session beginning at 6 p.m. EDT on Monday, November 1, 2010 in the Hynes Auditorium. The presentation will include complete response and sustained virologic response rates for patients who received the GI-5005 plus SOC as well as SOC patients in the control arm of the study.

Additionally, Dr. John M. Vierling of Baylor College of Medicine will present a poster titled "GI-5005 Therapeutic Vaccine Improves Deficit in Cellular Immunity in IL28B Genotype T/T, Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 When Added to Standard of Care PEG-IFN-Alfa-2A/Ribavirin," on Tuesday, November 2, 2010 in the Hynes Exhibit Hall C.

GI-5005 is a therapeutic vaccine candidate that the company believes generates HCV specific T-cell responses and improves virologic responses in patients with chronic hepatitis C infection. 

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 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.