GlobeImmune, Inc reported that use of GI-5005 in addition to standard of care (SOC) resulted in 94% early virologic response (EVR) in treatment naïve patients with hepatitis C in a Phase 2 clinical trial. EVR is defined as at least a 99% reduction in the virus load at the 12 week mark, and serves as early indicator of the likelihood of eradicating the virus or achieving sustained virologic response (SVR). Treatment naïve patients in the GI-5005 plus SOC arm were 8 – 12% more likely to achieve EVR than those receiving SOC (pegylated interferon and ribavirin) alone. Patients in GI-5005 also demonstrated improvements in serum fibrosis (Fibrotest) and necrosis (Actitest) markers which may lead to improvements in liver inflammation, necrosis, and fibrosis – symptoms of hepatitis. The results suggest that GI-5005 may act in a complimentary manner to the SOC. GI-5005, being developed for the treatment of chronic hepatitis C, is one of several Tarmogens, genetically modified yeast designed to express specific proteins, under development at GlobeImmune. Louisville, Colorado-based GlobeImmune is also developing products for several oncology indications.
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