GLOBEIMMUNE PRESENTS INTERIM DATA FROM HEPATITIS C STUDY

GlobeImmune has announced positive interim results from study GI-5005-01, a randomized, placebo-controlled, multicenter, dose-escalation, Phase 1b study of GI-5005 in patients chronically infected with hepatitis C virus (HCV). The data were presented at the annual meeting of the American Association for the Study of Liver Diseases. GI-5005 generated cellular immune responses in 41 percent of patients, elicited a statistically significant improvement in alanine amino transferase levels from baseline and caused viral load reductions of nearly 1 log 10 in three patients, two of whom had positive immune responses after only a three month course of GI-5005 monotherapy. No meaningful safety concerns were seen in the study to date.

The purpose of the ongoing study is to evaluate the safety and preliminary efficacy of five weekly subcutaneous doses followed by two monthly subcutaneous doses of GI-5005 in ascending dose groups in patients chronically infected with hepatitis C virus. Patients that were treatment naïve, partial responders, or relapsers to an interferon-based regimen with or without ribavirin were eligible for the study.

The GI-5005 Tarmogen (targeted molecular immunogen) is a whole, heat-killed, recombinant Saccharomyces cerevisiae yeast engineered to express a hepatitis C virus fusion protein composed of large segments of NS3 protease and core protein sequences. Tarmogens are believed to activate both an innate immune response via toll-like receptors, as well as an adaptive, antigen-specific cellular immune response.