Source: DGNews  |  Posted 1 year ago

By Chris Berrie

VIENNA, Austria -- April 22, 2010 -- Adding a novel tarmogen vaccine (GI-5005)
to the standard of care of chronic hepatitis C virus (HCV) genotype 1 increases
sustained virological response and promotes alanine aminotransferase (ALT)
normalisation in patients by the end of treatment.

GI-5005 is a therapeutic vaccine expressing HCV NS3 and core antigens. GI-5005
elicits antigen-specific T-cell responses with the goal of improving the rate
of immune-mediated elimination of HCV-infected hepatocytes.

"The study was designed to evaluate a product that boosts the immune response
to 2 important hepatitis C proteins and serves as an adjunct to other
therapies, in an effort to increase eradication rates of the virus," said lead
investigator Ira M. Jacobson, MD, Center for the Study of Hepatitis C, Weill
Cornell Medical College, New York, New York.

Dr. Jacobson presented results of the randomised, open-label, phase 2 trial on
April 15 at the 45th Annual Meeting of the European Association of the Study of
the Liver (EASL 2010).

By the end of treatment, the addition of GI-5005 to pegylated interferon
(PEG-IFN) alfa-2a plus ribavirin (RBV) significantly improved the proportion of
patients with complete virological response, compared with PEG-IFN alfa-2a/RBV
alone (63% vs 45%; P = .037).

This improvement was seen in patients who were treatment-naïve (74% vs 59%;
P = .133) as well as in previous non-responders (33% vs 11%;
P = .125).

The addition of GI-5005 to standard of care also significantly improved ALT
normalisation at end of treatment (61% vs 36%; P = .018).

Patients in the first arm of the study received an initial run-in of 5 weekly
doses of GI-5005 monotherapy (weeks 1-4, week 8), followed by 2 monthly doses
of GI-5005, and then monthly GI-5005 combined with PEG-IFN alfa-2a/RBV for
either 48 or 72 weeks.

Patients in the second arm received only PEG-IFN alfa-2a/RBV for 48 or 72 weeks.

Patients who were treatment-naïve received 48 weeks of treatment, and those who
had previous treatment failure received 72 weeks of treatment in both arms.

By the end of treatment, 13.2% of patients receiving GI-5005 and 12.3% of
patients receiving standard of care of alone discontinued treatment due to
adverse events (mainly fatigue).

GI-5005 is the first therapeutic vaccine to show a favourable impact on a range
of clinical endpoints in this chronic infectious disease. "We believe this
serves as an excellent foundation for further exploration of this technology,"
said Dr. Jacobson.

Funding for this study was provided by GlobeImmune Inc.

[Presentation title: GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin
Significantly Improves Virologic Response and ALT Normalization at
End-of-Treatment and Improves SVR24 Compared to PEG-IFN/Ribavirin in Genotype-1
Chronic HCV patients. Abstract 2006]