GlobeImmune Initiates Phase 2 Study of a Novel T Cell Stimulating Cancer Vaccine (GI-6207) Targeting CEA in Patients with Metastatic Medullary Thyroid Cancer
(Thomson Reuters ONE) -
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.
GI-6207
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 months.
About GlobeImmune
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 www.globeimmune.com.
###
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 statements.
GlobeImmune Contact:
David Apelian, M.D., Ph.D., M.B.A.
Chief Medical Officer
T: 303-625-2820
information(at)globeimmune.com
GlobeImmune Media Contacts:
Lena Evans or Tony Russo, Ph.D.
Russo Partners, LLC
T: 212-845-4262 or 212-845-4251
lena.evans(at)russopartnersllc.com
tony.russo(at)russopartnersllc.com
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: GlobeImmune, Inc via Thomson Reuters ONE
[HUG#1689283]
Unternehmensinformation / Kurzprofil:
Datum: 03.04.2013 - 13:00 Uhr
Sprache: Deutsch
News-ID 245592
Anzahl Zeichen: 7148
contact information:
Town:
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Kategorie:
Business News
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