HEPATITIS C NEW DRUG PIPELINE

NEW DRUG INDEX

GI-50005

GlobeImmune - Therapeutic Vaccine

Description:

GI-50005 is a therapeutic vaccine being developed by GlobeImmune for the treatment of Hepatitis C. It is a Tarmogen expressing a hepatitis C virus NS3-Core fusion protein. Tarmogens are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein targets that stimulate the immune system against diseased cells.

Clinical Milestones:

IND March 2005
Phase 1b start July 2005
Phase 2 start December 2007

Highlights:

In the Phase 1b trial

Viral load reductions in GI-5005 treated patients ranging from -0.75 log10 to -1.4 log10.

0% placebo subjects normalized their ALT levels on study
- 11% from the first 4 dose groups combined (through 10YU) normalized ALT
- 43% of the 20YU cohort normalized ALT levels on treatment
- 50% of the 40YU cohort normalized ALT levels on treatment

No placebo subjects (0 / 19) normalized their ALT on study drug, or had near log10 reductions of viral load on study drug.

Press Release

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