BioCentury
ARTICLE | Clinical News

NuThrax: Phase II started

January 21, 2013 8:00 AM UTC

Emergent began a double-blind, active-controlled, U.S. Phase II trial to evaluate 2 dose levels of NuThrax using 2 and 3-dose immunization schedules in about 168 healthy volunteers. The vaccine has Fast Track designation in the U.S. to prevent anthrax infection and is being developed under FDA's animal rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. Emergent licensed CPG 7909 from Pfizer. ...