Dynavax's HEPLISAV(TM) Hepatitis B Vaccine Shows 100% Seroprotection Regardless of Vaccination Schedule in Phase 2 Trial
Dec 4, 2006 11:00:00 (ET)
BERKELEY, Calif., Dec 04, 2006 /PRNewswire-FirstCall via COMTEX/ -- Dynavax Technologies Corporation (DVAX, Trade ) announced today positive results from a Phase 2 trial comparing two different vaccination schedules of HEPLISAV, its hepatitis B virus (HBV) vaccine. The primary endpoint is comparative seroprotection after the second dose. The data was reported today in a poster at the Canadian Immunization Conference in Winnipeg, Manitoba, Canada by Dr. Scott A. Halperin, Professor of Pediatrics and Microbiology and Immunology at Dalhousie University and Head of Pediatric Infectious Disease at the Halifax-based IWK Health Center.
The data show that 100% seroprotection is achieved whether the second dose is administered one or two months after the first.
According to Melissa Malhame, project leader for hepatitis B vaccines, "The data presented in Canada are the first reported that support our decision to study a two-dose, 0 and 1-month vaccination schedule for HEPLISAV in our upcoming Phase 3 trials. By vaccinating at 0 and 1 month, we once again see that HEPLISAV has a rapid onset of immunogenicity that can effectively be translated to an even shorter, more convenient vaccination schedule without compromising effectiveness."
Dr. Halperin indicated that 100% of all subjects were seroprotected at month three (3) and that all subjects sustained seroprotection at month eight (8). HEPLISAV was found to be safe and well tolerated.
The Phase 2 trial enrolled more than 40 seronegative subjects, 18 - 39 years of age, at one study site in Canada. One group of subjects received HEPLISAV at 0 and 1 month; the other group received HEPLISAV at 0 and 2 months.
Dynavax plans to pursue approval of a two-dose regimen administered at 0 and 1 month, and expects to initiate multi-center, international Phase 3 trials in Europe, Canada and the United States before the year-end, comparing the two-dose regimen against Engerix-B in patients from 11 to 55 years of age. The first dosing is expected in Canada, followed in early 2007 by dosing in the U.S. and in Europe. These trials are expected to be completed in 2008.
Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) 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. As a result of its acquisition of Rhein Biotech in April 2006, the company has secured manufacturing capabilities in Dusseldorf, Germany for producing both clinical and commercial quantities of the vaccine.
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