Dynavax Technologies Corporation announced that Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration, has approved the initiation of the Company’s next Phase 3 trials in Canada. Initiation of the Canadian studies is expected to facilitate enrollment for the multi-center trials. Immunizations in the U.S. have begun, while the Canadian sites are expected to begin enrollment shortly. In Canada, the Health Products and Food Branch (HPFB) of Health Canada regulates the development of new drugs and vaccines.
One trial is designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV, the Company’s investigational adult hepatitis B vaccine. The second trial compares HEPLISAV to Engerix-B in patients with chronic kidney disease. These studies are directed toward fulfilling licensure requirements in Canada, in addition to the U.S and Europe. HEPLISAV has been shown in two previous Phase 3 trials to enhance protection more rapidly and with fewer doses than a currently licensed vaccine.
The lot-to-lot consistency trial will enroll approximately 2,000 patients in Canada and in the U.S., 1600 of whom will receive HEPLISAV. Patients randomized to the comparator arm will receive Engerix-B, a currently licensed hepatitis B vaccine. The chronic kidney disease trial will enroll approximately 600 patients in Canada, the U.S. and Germany, 300 of whom will receive HEPLISAV. Patients randomized to the comparator arm will receive Engerix-B.
Data from these trials are expected in mid-2011. The hepatitis B surface antigen in the HEPLISAV lots being evaluated was produced in Dynavax’s manufacturing facility in Dusseldorf, Germany. This facility was recently upgraded and licensed in the European Union for commercial production of hepatitis B surface antigen.
