GlobeImmune annouced GS-4774 (GI-13020) into Phase 2
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/.
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