Phase 3 Data on HEPLISAV(TM) in Adults Aged 18-55 Published in VACCINE
BERKELEY, CA, Feb 13, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) announced today that results of a pivotal Phase 3 trial of
HEPLISAV (HBV-10) were published online in the journal VACCINE. Data from this
study will be used to support the HEPLISAV Biologics License Application (BLA)
submission for an indication in adults 18-70 years of age. The article concludes
that a short, two-dose regimen of HEPLISAV over 1 month was well-tolerated and
induced superior immunogenicity and earlier onset of protection than a three-dose
regimen of a licensed hepatitis B vaccine over 6 months.
The article entitled "Comparison of Safety and Immunogenicity of Two Doses of
Investigational Hepatitis B Virus Surface Antigen Co-administered with an
Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide and Three Doses of a
Licensed Hepatitis B Vaccine in Healthy Adults 18-55 Years of Age" describes the
results from one of the two pivotal Phase 3 trials of HEPLISAV. Dr. Scott
Halperin of Dalhousie University was the principal investigator and lead author.
The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B(R) in
2,415 adults randomized in a ratio of 3:1, HEPLISAV to Engerix-B. The
seroprotection rate at the primary endpoint after 2 doses for HEPLISAV (95%) was
significantly higher than after 3 doses for Engerix-B (81%). Superiority of the
seroprotection rates for HEPLISAV was demonstrated at all time points measured.
Dynavax plans to submit the BLA for HEPLISAV by the middle of May for an
indication in adults 18-70 years of age.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3
trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than
current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV.
HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist known as 1018 ISS to enhance the immune response.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious and
inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase
3 investigational adult hepatitis B vaccine designed to provide rapid and
superior protection with fewer doses than current licensed vaccines. For more
information visit dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking statements," including those
relating to the HEPLISAV BLA, planned indication, and timing of the submission,
that are subject to a number of risks and uncertainties. Actual results may
differ materially from those set forth in this press release due to the risks and
uncertainties inherent in our business, including whether successful clinical and
regulatory development and approval of HEPLISAV and our process for its
manufacture can occur in a timely manner or without significant additional
studies or difficulties or delays in development or clinical trial enrollment,
whether our studies can support registration for commercialization of HEPLISAV;
the results of clinical trials and the impact of those results on the initiation
and completion of subsequent trials and issues arising in the regulatory process,
including whether the BLA will be accepted for filing; the Company's ability to
obtain additional financing to support the development and commercialization of
HEPLISAV and its other operations, possible claims against the Company based on
the patent rights of others; and other risks detailed in the "Risk Factors"
section of our current periodic reports with the SEC. We undertake no obligation
to revise or update information herein to reflect events or circumstances in the
future, even if new information becomes available. Information on Dynavax's
website at dynavax.com is not incorporated by reference in the
Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
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