PXVX0200: Phase III data

Data from 99 healthy volunteers in a double-blind, U.S. Phase III trial showed that a single oral dose of PXVX0200 met the co-primary endpoint of reducing the incidence of moderate to severe diarrhea in subjects challenged with V. cholerae at 90 days post-vaccination vs. placebo (12.1% vs. 59%). In January, PaxVax reported data from 68 healthy volunteers in the trial showing that a single oral dose of PXVX0200 met the other co-primary endpoint of reducing the incidence of moderate to severe diarrhea in subjects challenged with V. cholerae at 10 days post-vaccination vs. placebo (5.7% vs. 59%) (see BioCentury, Feb. 10). PaxVax is conducting 2 additional Phase III trials in about 3,000 subjects to evaluate the immunogenicity, safety and lot-to-lot consistency of the vaccine, with data slated for early 2015. The company plans to submit a BLA to FDA for the product next year. ...