Published on September 29, 2009 at 7:21 AM
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).
“After achieving pivotal trial data demonstrating HEPLISAV’s clinical benefit, we currently expect to complete these two registration trials within the next 24 months,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “The unmet medical need for better hepatitis B vaccination for certain groups such as chronic kidney disease patients is significant and is a large, servable market opportunity for Dynavax.”
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