GlobeImmune, Inc : GlobeImmune Initiates Phase 2 Study of a Novel T Cell
Stimulating Cancer Vaccine (GI-6207) Targeting CEA in Patients with Metastatic
Medullary Thyroid Cancer
LOUISVILLE, Colo., April 3, 2013 - GlobeImmune, Inc., announced today the
initiation of a Phase 2 clinical trial at the National Cancer Institute (NCI)
to evaluate GI-6207 in subjects with medullary thyroid cancer (MTC). Ravi A.
Madan, M.D., at the NCI Medical Oncology / Laboratory of Tumor Immunology and
Biology is the Principal Investigator for this study. GI-6207 is being
developed as part of a Collaborative Research and Development Agreement
between the NCI and GlobeImmune.
GI-6207-02 is a randomized Phase 2 study that is planned to enroll a total of
34 patients in a cross-over trial design. Patients will be treated with
either GI-6207 for one year or be observed for six months and then treated
with GI-6207 for one year. The primary endpoint for the trial will be the
effect of GI-6207 on changes in calcitonin levels after six months of GI-6207
treatment vs. observation. Calcitonin is a tumor marker that correlates with
tumor size in MTC. Elevated calcitonin values after surgery indicate
persistent or recurrent disease.
"We believe that MTC is an excellent clinical indication for Tarmogen^®
immunotherapy," said David Apelian, M.D., Ph.D., Chief Medical Officer at
GlobeImmune. "Observation is the current standard of care for minimally
symptomatic MTC with low tumor burden. However, in this setting we believe we
will be able to evaluate GI-6207-induced immune responses and potentially
correlate them with calcitonin levels in a short time frame."
Medullary Thyroid Cancer
Thyroid cancer is the most common type of endocrine malignancy in the U.S.
with approximately 56,000 new cases in 2012. MTC, a subtype of thyroid
cancer, is aggressive, spreads quickly and has a poor prognosis, with
approximately 25 percent and 10 percent of patients alive at five and ten
years, respectively. Surgery is currently the only curative treatment for
MTC. Two drugs have been approved for the treatment of metastatic MTC. Both
of these products were approved on the basis of improved progression free
survival; neither has yet shown improved overall survival. Both of these
products have significant side effect profiles that include hypertension,
nausea, diarrhea, cardiac arrhythmias and thrombotic or bleeding episodes.
The GI-6207 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae
yeast genetically engineered to express a modified version of the human
carcinoembryonic antigen (CEA) protein as the target cancer antigen. CEA is
over-expressed in multiple human epithelial cancers, including MTC, where CEA
is almost universally expressed and is a diagnostic marker of the disease.
Preclinical studies have shown that GI-6207 can induce an immune response to
CEA as well as therapeutic anti-tumor responses. A previous Phase 1 study of
monotherapy GI-6207 demonstrated preliminary safety and tolerability, enhanced
immune responses and stable disease in 20% of subjects (5/25) beyond 3
GlobeImmune is a biopharmaceutical company focused on developing products for
the treatment of cancer and infectious diseases based on its proprietary
Tarmogen platform. Tarmogens activate the immune system by stimulating
cellular immunity, known as T cell immunity, in contrast to traditional
vaccines that predominately stimulate antibody production. To date, Tarmogen
product candidates have been generally well tolerated in clinical trials for
multiple disease indications and are efficient to manufacture. In May 2009,
the company entered into a collaboration agreement with Celgene Corporation
focused on the discovery, development and commercialization of product
candidates for the treatment of cancer. In October 2011, the company entered
into a worldwide, strategic collaboration with Gilead Sciences, Inc., to
develop Tarmogens for the treatment of chronic hepatitis B infection. For
additional information, please visit the company's website at
Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the
safe harbor provided by the Private Securities Litigation Reform Act of 1995.
These statements include, but are not limited to, statements regarding the
potential for GI-6207 to target medullary thyroid cancers expressing CEA and
Tarmogen's potential side effect profiles, the Company's ability to
successfully complete clinical trials, timing and eventual prospects for
approval to market any of the Company's products and the prospects for the
Company's collaborations. Such statements are based on management's current
expectations and involve risks and uncertainties. Actual results and
performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including, without
limitation, the risks and uncertainties associated with: the Company's
financial resources and whether they will be sufficient to meet the Company's
business objectives and operational requirements; results of earlier studies
and trials may not be predictive of future clinical trial results, the
protection and market exclusivity provided by the Company's intellectual
property; risks related to the drug discovery and the regulatory approval
process; and, the impact of competitive products and technological changes.
The Company disclaims any intent or obligation to update these forward-looking
David Apelian, M.D., Ph.D., M.B.A.
Chief Medical Officer
GlobeImmune Media Contacts:
Lena Evans or Tony Russo, Ph.D.
Russo Partners, LLC
T: 212-845-4262 or 212-845-4251
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information contained therein.
Source: GlobeImmune, Inc via Thomson Reuters ONE
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