Yesterday, GlobeImmune, Inc announced four-week results from its Phase 2 clinical trial of GI-5005. The 140 patient randomized, multi-center trial compared standard of care (SOC), pegylated interferon and ribavirin, to SOC plus GI-5005 in patients with chronic genotype 1 hepatitis C infection. Patients in the GI-5005 treatment arm showed an overall rate of viral clearance double that of patients receiving SOC alone in all major subgroups. Treatment naïve patients with high viral loads receiving GI-5005 plus SOC also showed a 2.6 fold improvement in rapid virologic response rate (RVR). The rate of viral reduction in peripheral blood also increased significantly in patients receiving GI-5005. The data will be presented in a poster next week at the AASLD meeting (American Association for the Study of Liver Diseases) by principal investigator John G. McHutchison, M.D. of Duke University.
Hepatitis C is a chronic disease caused by the Hepatitis C virus (HVC) that is transmitted through blood to blood contact. Initially, many patients may be asymptomatic or develop mild flu-like symptoms, but long term the disease can cause significant liver damage eventually leading to cirrhosis. In the acute phase (first 6 months after contraction) about 20% of patients clear the disease spontaneously, but after the initial period (chronic hepatitis C) spontaneous clearance is unlikely necessitating medical intervention. The current standard of care has primary activity as an antiretroviral, which limits the ability of the HVC virus to replicate. However, these medications do not speed the clearance of the virus from the liver, a step necessary for treatment success, which results in the need for extended courses of treatment of about 24 to 48 weeks.
GI-5005, a targeted molecular immunogen (Tarmogen®), seems to offer a good complement to the SOC, or more broadly any retroviral drug, because its action focuses on clearing HVC from the liver rather than preventing replication. Tarmogens, genetically modified whole yeast cells, are designed to stimulate the body’s own immune response, specifically killer T cells, against diseased cells. The Tarmogens are engineered to contain a disease specific protein antigen which upon release in the body generates a targeted immune response to this protein, resulting in selective destruction of diseased cells with limited impact on healthy cells. GlobeImmune, Inc., a privately held company based in Louisville, Colorado, has other Tarmogens in development for the treatment of infectious diseases and cancers. For more information, please visit the company’s web site.
