Vacc-4x: Additional Phase IIb data

Bionor reversed its previous decision to discontinue development of Vacc-4x after additional data from a double-blind, international Phase IIb trial in 135 HIV-infected patients showed that the vaccine met the secondary endpoint of significantly reducing viral load from baseline during the study period in the whole patient population (p=0.028) and in a subset of patients that did not resume ART vs. placebo (p=0.0012). Additionally, Vacc-4x significantly reduced viral load from pre-ART levels to week 52 by 0.55 log10 copies/mL (p=0.0003) vs. a non-significant 0.08 log10 copies/mL reduction for placebo (p=0.89).

Patients on ART with a CD4 count >400 cells/mm 3 received Vacc-4x or placebo for a 28-week immunization period. At week 28, all patients stopped ART and were monitored for 24 weeks. ART was resumed if CD4 count fell below 350 cells/mm 3 or by >50% of the count at the start of the ART-free period, or if a patients' viral load increased to >300,000 copies/mL. ...