2013-01-28 13:02:44 -
LOUISVILLE, Colo., Jan. 28, 2013 - GlobeImmune, Inc., today announced the
initiation of a Phase 1a clinical trial to investigate the safety and
immunogenicity of GI-13020 in healthy volunteers. The GI-13020 Tarmogen(®),
which GlobeImmune is developing in collaboration with Gilead Sciences, Inc.,
consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically
modified to express hepatitis B (HBV) antigens. This study is being conducted
under an Investigational New Drug application (IND) that was filed with the U.S.
Food and Drug Administration in December 2012. As a result of successfully
filing the IND, GlobeImmune received a milestone payment from Gilead.
The GI-13020-01 Phase 1a clinical trial is a randomized, open-label, dose
escalation trial assessing the safety, tolerability and immunogenicity of
various doses of GI-13020 in healthy adults. This study is designed to enroll
48
evaluable subjects at a single U.S. center.
"While approved anti-viral drugs have been shown to effectively suppress
replication of the hepatitis B virus, they rarely result in cures and must be
taken indefinitely," said David Apelian, M.D., Ph.D., Chief Medical Officer at
GlobeImmune. "GI-13020 is designed to activate an antigen-specific immune
response against HBV, and our development strategy will be to combine GI-13020
with direct-acting antiviral medicines to determine if the combination can
increase rates of surface antigen seroconversion, thereby leading to a cure for
infected patients."
HBV infection is the most common form of chronic viral hepatitis in the world.
Approximately 350 million people worldwide are chronic carriers of HBV,
resulting in more than 620,000 deaths annually from liver-related diseases. In
the United States, chronic HBV infection affects up to 1.4 million people.
Current treatment for HBV includes once-daily oral antiviral therapy medicines
to suppress virus replication. These antiviral products have been effective in
controlling the disease but generally do not result in a long-term cure, thus
requiring chronic suppressive therapy.
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.
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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-13020 to target HBV and potentially cure an infection, 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@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@russopartnersllc.com
tony.russo@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
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