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Home » DYNAVAX INITIATES PIVOTAL PHASE III TRIAL VACCINE
DYNAVAX INITIATES PIVOTAL PHASE III TRIAL VACCINE
Dynavax Technologies has announced the initiation of a pivotal Phase III clinical trial of its hepatitis B (HBV) vaccine.
The pivotal Phase III trial is designed to compare the effectiveness of Dynavax's HBV vaccine to GlaxoSmithKline's Engerix-B HBV vaccine in an older adult population that is more difficult to immunize with conventional vaccine. A second pivotal Phase III trial in a younger adult population to be conducted in Europe and Canada is anticipated to begin in early 2006.
Assuming positive data from these trials, Dynavax could potentially file a Biologic License Application for its HBV vaccine in 2007.
Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR-9) to stimulate an innate immune response. Dynavax's HBV vaccine combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection.
KEYWORDS Drug Pipeline Alert
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