Tuesday, October 06, 2009

GlobeImmune | Presenting Phase II Data @ AASLD

GlobeImmune (Louisville, CO) a clinical-stage company focused on developing targeted immunogens for the treatment of cancer and infectious diseases, has had an abstract (“GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus PEG-IFN/Ribavirin in Naïve Genotype 1 Chronic HCV Patients”) for their investigational hepatitis C virus product candidate accepted for presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (31 Oct. to 4 Nov. 2009 Boston, MA).

GlobeImmune will also present at AASLD end-of-treatment, 48-week data in interferon-naïve patients from a Phase II clinical study investigating the efficacy and safety of GI-5005 plus peg-interferon (peg- IFN) and ribavirin, the current standard of care, in patients with genotype 1 chronic HCV infection compared to patients receiving only SOC.

Chronic hepatitis C infection, a viral liver disease, is a major health epidemic worldwide. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4 million live in the United States with an additional 5 million in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma and 30% of liver transplants in the United States. The incidence of new symptomatic infections of hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person who is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control and Prevention estimate that there are up to 230,000 new hepatitis C infections in the U.S. every year. Currently, 8,000 to 10,000 deaths each year are attributed to hepatitis C.

The GI-5005 Tarmogen expresses a fusion protein encompassing sequences from both HCV NS3 and Core proteins. NS3 and Core are abundantly expressed in infected cells, are required for viral replication and contain targets that are recognized by both CD4+ "helper" and CD8+ "killer" T cells. Both the Core and NS3 proteins are highly conserved among HCV genotypes 1a and 1b, the HCV strains most prevalent in the U.S. In December 2007, GI-5005 initiated a multi-center, randomized, Phase 2 study in combination with standard of care (pegylated interferon plus ribavirin).

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