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ARTICLE | Clinical News

PXVX0200: Interim Phase III data

February 10, 2014 8:00 AM UTC

Interim data from 68 healthy volunteers in a double-blind, U.S. Phase III trial showed that a single oral dose of PXVX0200 reduced the incidence of moderate to severe diarrhea in subjects challenged with V. cholera at 10 days post-vaccination, a co-primary endpoint, vs. placebo (5.7% vs. 60.6%). PXVX0200 was well tolerated. The trial is also evaluating the vaccine in subjects challenged at 90 days post-vaccination, the other co-primary endpoint, with final data expected in May. PaxVax said it plans to conduct additional Phase III trials in about 3,000 subjects to evaluate the immunogenicity, safety and lot consistency of the vaccine. The trials are slated to begin immediately after the company closes a series C round, which is expected by April. ...