Dynavax Presents Additional Phase 3 Data for HEPLISAVTM Hepatitis B Vaccine at DDW Medical Conference
9:00a ET June 3, 2009 (Business Wire)
Dynavax Technologies Corporation (Nasdaq:DVAX) today presented additional Phase 3 clinical data for HEPLISAV(TM) hepatitis B vaccine in a poster session at the Digestive Disease Week (DDW) medical conference in Chicago. In addition to meeting its primary endpoint in this Phase 3 trial as previously reported, HEPLISAV provided more rapid and increased seroprotection against hepatitis B viral infection and with fewer doses than the licensed vaccine. The data show the differences to be particularly significant in the subset of subjects over 40 years of age who are usually less likely to respond to immunization.
"Vaccination is critical for the prevention of hepatitis B viral infection and its spread, but the lengthy dosing regimen of current vaccines leaves many unprotected," commented Scott A. Halperin, M.D., Director Clinical Trials Research Center, Dalhousie University, IWK Heath Centre of Halifax, Nova Scotia and Lead Investigator in the Phase 3 trial. "The Phase 3 data demonstrate HEPLISAV's superior immunogenicity and similar safety profile versus the licensed vaccine, particularly for adults over 40 who are more difficult to protect against this preventable viral infection."
This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B(R) at 0, 1, and 6 months.
In a subanalysis of subjects over 40 years of age, at each time point during the trial there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.
Ages 40-55 Dosing Regimen Seroprotection Rate (1) Treatment Group at Month 1 2 3 6 7 HEPLISAV 2 doses (0, 1 month) 18% 84% 92%(2) 97% 97% Engerix-B 3 doses (0, 1, 6 months) 3% 21% 17% 27% 75%(2)
A copy of the poster is available at
Dynavax Technologies Corporation - News & Events. Dynavax's abstract #587659 is titled "A Phase 3 Safety and Efficacy Study to Compare Immune Responses following Either Two Doses of Hepatitis B Surface Antigen Combined with Immunostimulatory Phosphorothioate Oligonucleotide (HBsAg-ISS) or Three Doses of Conventional Hepatitis B Vaccine."
As previously reported, safety results from this trial demonstrated the safety profile of HEPLISAV and Engerix-B appeared similar. Subjects were randomized 3 to 1 to receive HEPLISAV or Engerix-B and one case of vasculitis was reported in each of the treatment groups. Following the report of the severe adverse event of Wegener's granulomatosis, an uncommon form of vasculitis, HEPLISAV was placed and remains on clinical hold by the U.S. Food and Drug Administration (FDA). Dynavax is in active discussions with regulatory agencies to resolve the FDA's clinical hold on HEPLISAV and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.
About HEPLISAV
HEPLISAV is a Phase 3 hepatitis B vaccine aimed at unmet medical needs in the vaccination of adults and end-stage renal disease patients by providing rapid and increased protection with fewer doses. HEPLISAV combines a proprietary immunostimulatory sequence (ISS), which targets Toll-like Receptor 9, with hepatitis B surface antigen (HBsAg).
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