Dynavax Initiates Phase 3 Registration Trial For Hepatitis B Vaccine

Dynavax Technologies has announced the initiation of a phase 3 registration trial for Heplisav 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 a phase 3 investigational adult hepatitis B vaccine designed to provide protection with fewer doses than current licensed vaccines. Dynavax believes that these studies, taken together, could support registration filing of Heplisav with the FDA.

Dynavax’s phase 3 trial is enrolling approximately 600 patients with chronic kidney disease. After being randomised 1 to 1, patients will receive either 3 doses of Heplisav (at 0, 1, and 6 months) or 8 doses of the current licensed vaccine Engerix-B (2 doses at 0, 1, 2, and 6 months), said the compnay.

Dino Dina, president and CEO of Dynavax, said: “After achieving pivotal trial data demonstrating Heplisav’s clinical benefit, we currently expect to complete these two registration trials within the next 24 months. 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.”