GlobeImmune Announces Presentation of GI-4000 Phase 2 Data at IASLC World Conference on Lung Cancer
(Thomson Reuters ONE) -
Sydney, Australia, October 28, 2013 - GlobeImmune, Inc. announced that data from
a Phase 2 clinical trial of the GI-4000 Tarmogen(® )in patients with non-small
cell lung cancer (NSCLC) will be presented today at the International
Association for the Study of Lung Cancer (IASLC) 15(th) World Conference on Lung
Cancer in Sydney, Australia. The study evaluated GI-4000 as consolidation
therapy in patients with tumors with mutations in K-Ras following treatment
with curative intent for Stage I-III NSCLC. The study was performed at Memorial
Sloan Kettering Cancer Center (MSKCC) in New York.
In this study, 24 patients with Stage I-III, K-Ras mutant(+) NSCLC who
successfully completed first-line treatment were enrolled in the study.
Additionally, 64 case-matched, contemporary control patients were followed at
MSKCC. GI-4000-treated patients demonstrated a trend for improved 1-, 2- and 3-
year survival over the case-matched controls.
Overall Survival GI-4000 Control
Year 1 100% 93%
Year 2 100% 88%
Year 3 92% 83%
HR = 0.58; p=0.29
Dr. Jamie Chaft of MSKCC, the lead author of the abstract, will present the
results during an oral session at 4:15 p.m. today in the Bayside Gallery B
auditorium. The abstract (#2451) titled, "Phase 2 study of the GI-4000 Kras
vaccine following curative therapy in patients with Stage I-III lung
adenocarcinoma harboring a Kras G12C, G12D, G12V or G12R mutation," is published
online at the IASLC web site.
"Despite multi-modality treatment with curative intent, most patients with
early-stage lung cancers recur and die of their disease," said Dr. Chaft. "The
most frequent acquired genetic cause of non-small cell lung cancers is mutation
in a gene called K-ras. Unfortunately, unlike their less common counterparts,
K-Ras-mutant lung cancers have no standard targeted treatment options available.
Better treatments designed specifically for patients with K-Ras-mutant lung
cancers are an unmet need in lung cancer care."
About GI-4000
GI-4000 is a series of Tarmogen products intended to generate a T cell immune
response in patients against cells containing Ras mutations. Mutations in K-Ras
are believed to be responsible for over 180,000 cases of cancer annually in the
United States, including significant proportions of pancreas, NSCLC, colorectal,
ovarian and other cancers.
About NSCLC
Lung cancer remains the leading cause of cancer in the United States, with
228,190 new cases and 159,480 deaths estimated to occur in 2013. Non-small cell
lung cancer accounts for approximately 85% (194,000) of all lung cancers.
Approximately 25% of NSCLC tumors harbor a Ras mutation and appear to be
resistant to chemotherapy and targeted therapies, offering patients fewer
treatment options. For more information on NSCLC, please see the American
Cancer Society website.
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 Tarmogens to target NSCLC, Tarmogen 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:
Timothy C. Rodell M.D.
President and Chief Executive 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
GLOBEIMMUNE INVESTOR CONTACT:
Susan Noonan
S.A. Noonan Communications
T: 917-513-5303
susan(at)sanonan.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#1738435]
Unternehmensinformation / Kurzprofil:
Datum: 27.10.2013 - 21:00 Uhr
Sprache: Deutsch
News-ID 309655
Anzahl Zeichen: 7196
contact information:
Town:
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Kategorie:
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