I don't remember if we commented on these results when they were presented at AASLD , but here's the PR anyway. Maybe Schiff is looking at it as a patient-friendly tx. with possible benefit on liver health ( evidenced by lower ALTs ) without having much expectation of achieving SVR. Or , he may know of patients that have continued to show viral load reduction beyond what is reported below and thinks that at least a few of them may achieve SVR eventually.
LOUISVILLE, CO – October 30, 2006 – GlobeImmune, Inc. today announced positive interim results from Study GI-5005-01, a randomized, placebo-controlled, multi-center, dose-escalation, Phase 1b study of GI-5005 in patients chronically infected with hepatitis C virus (HCV). The data were presented today at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). GI-5005 generated cellular immune responses in 12/29 patients (41%), elicited a statistically significant improvement in alanine amino transferase (ALT) levels from baseline and caused near 1 log10 viral load reductions 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 interim results of this study appear to demonstrate a robust immunologic response in patients with chronic HCV,” said Timothy C. Rodell, M.D., GlobeImmune’s President and CEO. “To our knowledge, no other HCV therapy in development or on the market has shown the ability to convert the weak cellular immune response typically seen in chronically infected patients to a strong cellular response. The immune responses observed in chronically infected patients treated with GI-5005 resemble those of patients in the early stages of exposure to hepatitis C virus during which a proportion of patients can spontaneously cure themselves. This suggests that GI-5005 has the potential to transform the immune activity of chronically infected patients into a more effective response and drive favorable clinical outcomes in the setting of chronic hepatitis C disease.”
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. Interim results on the first 40 subjects enrolled were presented in a poster at AASLD entitled: “Interim Results from a Randomized, Double-blind, Placebo-controlled Phase 1b Study in Subjects with Chronic HCV after Treatment with GI-5005, a Yeast-Based HCV Immunotherapy Targeting NS3 and Core Proteins.”
The preliminary results of the study to date have demonstrated:
1) GI-5005 is well tolerated with no serious adverse events (SAEs), dose limiting toxicities (DLTs), and no discontinuations due to adverse events (AEs) to date.
2) GI-5005 converted subjects with a weak cellular immune response typical of chronic HCV patients to a strong cellular immune response with broad HCV epitope coverage, consistent with the immune response seen in patients during the acute stage of infection.
3) The immune responses were observed in association with favorable changes in viral load and ALT:
a. A statistically significant difference in maximum change in ALT (a surrogate of hepatic injury) from baseline in all GI-5005 treated subjects compared to placebo treated subjects (p=0.03).
b. Three treated patients had viral load reductions approaching 1 log10 (0.75 log10 – 0.90 log10); no placebo patients had HCV RNA reductions > 0.65 log10.
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