Researchers for Dynavax Technologies of Berkeley, California, have reported that a Phase II/III trial of its experimental hepatitis B vaccine produced a statistically significant improvement in protection when compared with GlaxoSmithKline's Engerix-B. Dynavax plans to launch a pivotal Phase III trial of the vaccine in mid-2005.
"The clear demonstration of superiority of our HBV vaccine in a population with weakened immune responses is the cornerstone of our global regulatory and commercial strategy," said Dino Dina, MD, president and CEO. "Based on the compendium of clinical data showing enhanced efficacy, faster response and shorter regimens, we believe that our vaccine could become a new standard of care, especially for populations that are at high risk, that are currently underserved and whose need for protection is urgent. These populations include dialysis patients, individuals who are infected with hepatitis C virus, people who have failed to achieve seroprotection with conventional vaccines as well as healthcare workers and international travelers. We believe we could readily compete in these high-value markets with a differentiated product that is safe and offers greater effectiveness and convenience."
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