Dynavax Technologies Corporation (NASDAQ: DVAX) today announced
completion of planned enrollment in the ongoing phase 3 clinical trial
of HEPLISAV-B, its investigational adult hepatitis B vaccine. More than
8,250 adults, including over 1,100 diabetic subjects, have been enrolled
at 40 sites in the U.S.
This large safety and immunogenicity study (known as HBV-23) is
intended to provide an adequately-sized database of vaccinated subjects
to enable the U.S. Food and Drug Administration to complete its review
of the pending HEPLISAV-B Biologics License Application. The study is
also designed to assess the immunogenicity of HEPLISAV-B in adults for
whom approved hepatitis B vaccines are less effective, including those
with type-2 diabetes mellitus.
"Concluding enrollment of HBV-23 is a major milestone in the path to
potential approval of HEPLISAV-B. I am pleased with the team's efforts
to complete this key phase of the trial three months ahead of schedule"
said Eddie Gray, Chief Executive Officer of Dynavax. "HEPLISAV-B is the
most advanced demonstration of our leadership in TLR biology and
validates our targeted approach to modulating the immune system to
prevent and treat disease."
HBV-23 is an observer-blinded, randomized, active-controlled trial.
Adult subjects between the ages of 18 and 70 have been randomized in a
2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of
the control vaccine, Engerix-B®. Safety follow up will continue for 12
months following each subject's second vaccination. All study visits
will be completed by October, 2015.
Additional details regarding HBV-23 are available at www.clinicaltrials.gov.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that
combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist to enhance the immune response. Dynavax has worldwide
commercial rights to HEPLISAV-B.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers and
develops novel vaccines and therapeutics in the areas of infectious and
inflammatory diseases and oncology. Dynavax's lead product candidate is
HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For
more information visit www.dynavax.com.
Read complete release here Labels: Dynavax, HEPLISAV-B, vaccine