GlobeImmune Announces Late-Breaker Presentation of Interim Efficacy and Safety Data for GI-5005 at AASLD 2008 Meeting
LOUISVILLE, CO - Sept. 24, 2008 - GlobeImmune Inc. today announced that a late breaking abstract related to GI-5005, its investigational hepatitis C virus (HCV) product candidate, has been accepted for presentation at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place Oct. 31 through Nov. 4, 2008, in San Francisco.
The abstract, titled "GI-5005 Immunotherapy Plus Peg- IFN/Ribavirin In Genotype 1 Chronic Hepatitis C Patients Compared to Peg-IFN/Ribavirin Alone in Naïve and Non-Responder Patients; Preliminary RVR and Viral Kinetic Analysis from the GI-5005-02 Phase 2 Study," was published online today by the AASLD.
At the AASLD meeting, GlobeImmune will present interim data from a Phase 2 clinical study investigating the efficacy and safety of GI-5005 plus peg-interferon (peg-IFN) and ribavirin, the current standard of care (SOC), in patients with genotype 1 chronic HCV infection.
Dr. John G. McHutchison of Duke University is the lead author of the abstract that will be presented as part of a late breaking poster session beginning at 8 a.m. PDT on Monday, Nov. 3, 2008. The analysis will include rapid virologic response (RVR) rates and viral kinetic analyses for patients who have completed the first four weeks of triple therapy, as well as SOC patients in the control arm of the study.
GI-5005 is an immunotherapy product candidate that contains conserved HCV proteins and is designed to generate HCV specific T-cell responses in both the pre-clinical and clinical setting.
About GlobeImmune, Inc.
GlobeImmune is a private, Colorado-based company developing active immunotherapies called Tarmogens® for the treatment of cancer and infectious diseases. The Company's lead product candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection that has completed a Phase 1b clinical trial. GI-5005 is designed to complement both the current standard of care and emerging novel therapies for hepatitis C infection. The Company has fully enrolled a 140- patient randomized, controlled Phase 2 study of GI- 5005 in combination with standard of care for chronic hepatitis C infection. The Company's lead oncology program, GI-4000, targets mutated versions of the Ras oncoprotein and is designed to be a treatment for cancers of the lung and gastrointestinal tract that contain mutated Ras. A randomized, placebo- controlled Phase 2 trial in patients with resected pancreas cancer in combination with adjuvant gemcitabine is ongoing.
For additional information, please visit the company's Web site at www.globeimmune.com.
The anticipated presentation will contain forward- looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs. 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 anticipated presentation.
Heidi Chokeir, Ph.D.
Russo Partners, LLC
Chief Business Officer
1450 Infinite Drive
Louisville, CO 80027
Posted: September 2008