is an excerpt from a GlobeImmune press release describing final
results from a Phase 2b study of GI-5005 in previously untreated
chronic hepatitis C patients.
GI-5005 HCV Product Candidate Improves
Sustained Virologic Response by 10 Percent, Demonstrating
Potential to Be First Therapeutic Vaccine for HCV
Phase 2b Data for GI-5005 in Treatment-Naive Patients Presented
at 45th Annual Meeting of the European Association for the Study
of the Liver
Louisville, CO -- April 15, 2010 -- GlobeImmune, Inc. today
announced final Phase 2b data for GI-5005, the Company's investigational
Tarmogen product candidate, demonstrating its potential to be
the first successful therapeutic vaccine for chronic hepatitis
C virus (HCV) infection. The data show that GI-5005 increased
the sustained virologic response (SVR) in genotype 1 interferon-naive
patients to 58 percent when used in combination with standard
of care (SOC), pegylated interferon-a2a plus ribavirin, versus
48 percent for patients receiving SOC alone. The study also
demonstrated that adding GI-5005 to SOC results in an improvement
in normalization of alanine aminotransferase (ALT) levels and
suggests an improvement in liver biopsies, both markers used
to assess liver damage.
Ira M. Jacobson, MD, the Vincent Astor Distinguished Professor
of Medicine at NewYork-Presbyterian/Weill Cornell Medical Center,
and John G. McHutchison, MD, Associate Director of the Duke
Clinical Research Institute at Duke University Medical Center,
presented the data today at the 45th Annual Meeting of the European
Association for the Study of the Liver (EASL).
"This is the first clinical study to demonstrate that a
therapeutic vaccine can be used for patients with chronic hepatitis
C infection," said Dr. Jacobson. "With its novel mode
of action and apparent safety profile, the GI-5005 therapeutic
vaccine could have an important impact on the treatment of this
The Phase 2b study compared GI-5005 plus SOC versus SOC alone
in 140 patients with chronic genotype 1 hepatitis C infection
who were either treatment-naive or prior non-responders to SOC.
On an intent-to-treat basis (patients having received at least
one dose of combination therapy), treatment-naive patients receiving
GI-5005 plus SOC as a triple therapy had an SVR rate of 58 percent,
compared to an SVR rate of 48 percent in treatment-naive patients
receiving SOC alone, a relative improvement of 21 percent. GI-5005
triple therapy demonstrated a 67 percent relative improvement
in the proportion of patients achieving normalization of ALT
levels on therapy. ALT is a marker of liver injury that is used
to follow liver function in HCV patients. In addition, a trend
toward an improvement in biopsy necroinflammatory scores was
seen with a 39 percent relative improvement 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. Importantly, GI-5005 did not increase
the discontinuation rates due to adverse events when added to
standard of care (GI-5005 + SOC - 13.2 percent vs. SOC alone
-- 12.3 percent).
"These data show that adding GI-5005 to standard of care
may give patients a clinically important advantage without added
toxicity," said David Apelian, MD, Ph.D., Chief Medical
Officer at GlobeImmune. "We believe that this is an important
medical breakthrough in the treatment of hepatitis C, and it
may have implications for the development of treatments for
other chronic viral infections."
Pharmacogenomic data demonstrating a correlation between GI-5005
treatment effect and polymorphisms in the human IL-28 B gene
will also be presented at the EASL meeting on Saturday, April
17 by Dr. McHutchison.
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 structural proteins and
is designed to generate an HCV specific T-cell response.
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 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
Center for the Study of Hepatitis C, Weill Cornell Medical
College, New York, NY; Duke Clinical Research Institute, Duke
University Medical Center, Durham, NC; Department of Medicine,
University of Arizona College of Medicine, Tucson, AZ; Center
for Liver Diseases, University of Miami School of Medicine,
Miami, FL; Department of Medicine, University of Colorado Denver,
Aurora, CO; Scripps Clinic, La Jolla, CA; Maryland Digestive
Disease Research, Laurel, MD; Department of Medicine and Surgery,
Baylor College of Medicine, Houston, TX; St. Luke's Episcopal
Hospital, Houston, TX; Alamo Medical Research, San Antonio,
TX; South Denver Gastroenterology, Denver, CP; Center for Disease
of the Liver and Pancreas, Swedish Medical Center, Englewood,
CO; University of Hawaii, Honolulu, HI; Liver Institute of Virginia,
Bon Secours Health System, Newport News, VA; Northwest Indiana
Center for Clinical Research, Valparaiso, IN; Gastrointestinal
Specialists of Georgia, Marietta, GA; QST Consultations, LTD,
Allendale, MI; GlobeImmune, Inc., Louisville, CO; AIP Laboratories,
Silver Spring, MD; University of Texas Southwestern Medical
Center at Dallas, Dallas, TX; Columbia University College of
Physicians & Surgeons, New York, NY; Saint Louis University,
St. Louis, MO; Henry Ford Hospital, Detroit, MI.
GlobeImmune, Inc. GlobeImmune GI-5005 HCV Product Candidate
Improves Sustained Virologic Response by 10 Percent, Demonstrating
Potential to Be First Therapeutic Vaccine for HCV. Press release.
April 15, 2010.
IM Jacobson, JG McHutchison, TD Boyer, and others. GI-5005 therapeutic
vaccine plus peg-IFN/ribavirin significantly improves virologic
response and ALT normalization at end-of-treatment and improves
SVR24 compared to peg-IFN/ribavirin in genotype-1 chronic HCV
patients. 45th Annual Meeting of the European Association for
the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18,
JG McHutchison, ZD Goodman, GT Everson, and others. GI-5005
therapeutic vaccine plus peg-IFN/ribavirin improves biopsy necro-inflammatory
scores and ALT normalization at 48 weeks versus peg-IFN/ribavirin
in genotype 1 chronic HCV patients. 45th Annual Meeting of the
European Association for the Study of the Liver (EASL 2010).
Vienna, Austria. April 14-18, 2010. (Abstract).
JG McHutchison, AJ Thompson, IM Jacobson, and others. Pharmacogenomic
analysis reveals improved virologic response in all IL-28b genotypes
in naive genotype 1 chronic HCV patients treated with GI-5005
therapeutic vaccine plus peg-IFN/ribavirin. 45th Annual Meeting
of the European Association for the Study of the Liver (EASL
2010). Vienna, Austria. April 14-18, 2010. (Abstract).