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
| Quelle: GlobeImmune, Inc.
LOUISVILLE, CO--(Marketwire - 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.