GlobeImmune Announces Milestone Payment for Initiation of Phase 2 Clinical Trial for GS-4774 (Formerly GI-13020) in Patients with Chronic Hepatitis B Virus Infection
(Thomson Reuters ONE) -
LOUISVILLE, Colo., October 15, 2013 - GlobeImmune, Inc., today announced that it
has earned a milestone payment from Gilead Sciences, Inc. under the terms of an
exclusive worldwide license and collaboration agreement established in 2011 for
the development and commercialization of Tarmogen products(®) for use in
conjunction with Viread(®) (tenofovir disoproxil fumarate) and other oral
therapies for the treatment of chronic hepatitis B virus (HBV) infection.
The milestone payment is based on the initiation of a Phase 2 clinical trial
investigating GS-4774 (formerly GI-13020) in patients with chronic hepatitis B
virus (HBV) infection. The GS-4774 Tarmogen, consists of whole, heat-killed,
recombinant S. cerevisiae yeast genetically modified to express HBV antigens.
The Phase 2 clinical trial will enroll patients in a randomized, open-label
trial evaluating different doses of GS-4774 in virally-suppressed patients. In
addition to continuing ongoing oral antiviral treatment, patients will be
treated with GS-4774 administered once per month. The primary endpoint for this
trial is decline in serum HBV surface antigen (HBsAg). Surface antigen
seroconversion defines a cure in chronically infected patients.
"GS-4774 demonstrated a favorable safety and immunogenicity profile in a
previous Phase 1 clinical trial, which paved the way for the initiation of this
Phase 2 study," said Timothy C. Rodell, M.D., Chief Executive Officer at
GlobeImmune. "We believe that the antigen-specific immune response against HBV
driven by GS-4774 may improve rates of seroconversion in patients already being
treated with antiviral therapy."
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.
For more information on the trial, please visit http://www.clinicaltrials.gov/.
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 tuberculosis, 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#1735535]
Unternehmensinformation / Kurzprofil:
Datum: 15.10.2013 - 13:00 Uhr
Sprache: Deutsch
News-ID 305867
Anzahl Zeichen: 6447
contact information:
Town:
Louisville, Colorado
Kategorie:
Business News
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