GlobeImmune Initiates Phase 1a Clinical Trial of GI-13020 in Healthy Volunteers
January 28, 2013 - London
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.
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 releasecontains "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.
David Apelian, M.D., Ph.D., M.B.A.
Chief Medical Officer
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Russo Partners, LLC
T: 212-845-4262 or 212-845-4251
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Source: GlobeImmune, Inc via Thomson Reuters ONE