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Positive results for GlobeImmune's hepatitis C drug in Phase I
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GlobeImmune has announced positive results from the company's randomized, placebo-controlled Phase Ib trial evaluating the safety, immunogenicity and initial efficacy of its chronic hepatitis C treatment.
http://www.pharmaceutical-business-review.com
The Phase Ib study of GI-5005 demonstrated strong trends for a dose-dependent response in patients that normalize their ALT (a marker of liver damage) compared with placebo, ranging from no normalizations in the placebo group up to 50% of the patients in the highest dose group (40YU).
Viral load reductions were achieved with only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral therapy. No placebo patients had near log10 reductions of viral load or demonstrated an immune response by ELISpot assay.
GI-5005 is GlobeImmune's lead infectious disease product from its proprietary Tarmogen active immunotherapy platform for the treatment of chronic hepatitis C infection. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets.
David Apelian, chief medical officer of GlobeImmune, said: "A Phase II trial comparing GI-5005 plus pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone is now being initiated at 50 centers in the US, EU, and India. Long-term GI-5005 salvage therapy will also be examined in this trial in patients who fail to achieve an early virologic response or do not tolerate treatment in the pegylated interferon/ribavirin arm."
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