FDAnews
www.fdanews.com/articles/100771-globeimmune-presents-results-from-gi-5005-tarmogen-study

GlobeImmune Presents Results From GI-5005 Tarmogen Study

November 7, 2007

GlobeImmune reported results from the additional higher dose cohorts from the company's randomized, placebo-controlled Phase 1b clinical trial evaluating the safety, immunogenicity and initial efficacy of GI-5005 in patients with chronic hepatitis C (HCV) infection.

GI-5005 showed a favorable safety profile to the highest planned dose without toxicity. Safety concerns generally were limited to transient local injection site reactions and transient mild constitutional complaints.

David Apelian, chief medical officer of GlobeImmune, said results indicated a short course of GI-5005 can generate an HCV-specific immune response associated with improved liver inflammation and clearance of infected hepatic cells. A Phase II trial comparing GI-5005 plus pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone is beginning at 50 centers in the U.S., the European Union and India.