Genocea announces Phase 2 GEN-003 optimization trial Genocea Biosciences announced the start of a Phase 2 dose optimization trial for GEN-003. The Phase 2 dose optimization study will enroll approximately 300 subjects from 17 institutions in the U.S. and will study six combinations of two antigen doses with each of three adjuvant doses alongside a placebo. All subjects will receive three doses of GEN-003 or placebo at 21-day intervals. The primary end point for the study is the change from baseline in viral shedding rate. The study is also designed to evaluate the impact on percentage of days with genital herpes lesions as reported by patients. Subjects receiving GEN-003 will be followed for 12 months after the last dose. Previously the company announced results from its Phase 1/2a clinical trial of GEN-003, which demonstrated, in the 30 microgram dose group, statistically significant reductions from baseline in viral shedding and genital lesion rates of up to 52% and 65% respectively, with a durability of effect to six months after dosing. The company said, "We look forward to announcing interim results from this trial in the middle of 2015.”
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