Dynavax Technologies Corporation announced that the US Food and Drug Administration (FDA) has removed the clinical hold for the Heplisav Investigational New Drug (IND) application in individuals with chronic kidney disease. Heplisav is a phase-3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.

As a result of the FDA's decision, Dynavax expects to initiate a phase-3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a phase-3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.

"The success of our scientific approach to resolving the clinical hold on HEPLISAV allows us to resume development of our enhanced hepatitis B vaccine," commented Dino Dina, president and chief executive officer of Dynavax. "After achieving strong efficacy data in our prior phase-3 pivotal trial, we are fully prepared to initiate the final registration trials for Heplisav."

Dynavax's global strategy as previously discussed with the FDA and the European Medicines Evaluation Agency (EMEA) is to develop Heplisav for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.

Heplisav is a phase-3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines. Over 2,500 individuals have been vaccinated with Heplisav to date.

Phase-3 data from Dynavax's PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of Heplisav over a 1 month period achieved a seroprotection rate of 92 per cent, compared to 75 per cent of subjects receiving three doses of a licensed vaccine over a six month period. For individuals with chronic kidney disease, clinical data from a small phase-1 and partially completed phase-2 trial will be reported at an upcoming medical conference.

Dynavax has worldwide commercial rights to Heplisav, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.