Dynavax Technologies Corporation Initiates Phase 3 Registration Trial in Chronic Kidney Disease Patients for HEPLISAVTM Hepatitis B Vaccine
Published: Sep 29, 2009
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX) today announced the initiation of a Phase 3 registration trial for HEPLISAVTM hepatitis B vaccine in individuals with chronic kidney disease. A second registration trial, a Phase 3 lot-to-lot consistency trial, is expected to begin in early 2010. HEPLISAV is an investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines. Dynavax believes that these studies, taken together, could support registration filing of HEPLISAV with the Food and Drug Administration (FDA).