GlobeImmune's Hepatitis C Therapeutic Vaccine

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--(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, John 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 David 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 John 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.