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 via COMTEX) --
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/.
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.
Timothy C. Rodell M.D.
President and Chief Executive Officer
GLOBEIMMUNE MEDIA CONTACTS:
Lena Evans or Tony Russo, Ph.D.
Russo Partners, LLC
T: 212-845-4262 or 212-845-4251
GLOBEIMMUNE INVESTOR CONTACT:
S.A. Noonan Communications
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Source: GlobeImmune, Inc via Thomson Reuters ONE
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