BERKELEY, CA -- (MARKET WIRE) -- 03/13/12 -- Dynavax
Technologies Corporation (NASDAQ: DVAX) announced today
that results of an early Phase 3 trial (HBV-04) of
HEPLISAV™ investigational hepatitis B vaccine were
published online in the journal VACCINE. The article
concludes that HEPLISAV was well-tolerated and demonstrated
superior and more durable seroprotection earlier than the
licensed comparator hepatitis B vaccine.
The article, entitled "Demonstration of Safety and
Enhanced Seroprotection Against Hepatitis B with
Investigational HBsAg-1018 ISS Vaccine Compared to a
Licensed Hepatitis B Vaccine" by first author Benjamin
Sablan, describes the results from a Phase 3 clinical trial
of HEPLISAV conducted in Asia. The trial compared the
safety and immunogenicity of HEPLISAV with
Engerix-B® in 412 adults 40-70 years of age. The
seroprotection rate at one month after the second dose in
the HEPLISAV group was 97% versus 24% in the Engerix-B
group (p < 0.0001). At one month after the third dose,
the seroprotection rates were 100% for HEPLISAV and 73% for
Engerix-B (p < 0.0001). Seroprotection rates at one year
after the first dose were 100% for HEPLISAV and 69% for
Engerix-B (p < 0.0001).
Senior study author and Vice President of Clinical
Development at Dynavax, Dr. William Heyward, commented,
"The 97% seroprotection rate of HEPLISAV after two
doses in older adults in this trial was early evidence of
the potential of HEPLISAV as a highly effective two-dose
vaccine for older adults. These results provided important
information leading to the design of our pivotal Phase 3
trial in adults 40-70 years of age in which HEPLISAV
provided a peak seroprotection of 98%".
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 Phase 3 trials, HEPLISAV demonstrated higher and earlier
protection with fewer doses than currently licensed
vaccines. Dynavax has worldwide commercial rights to
HEPLISAV. HEPLISAV combines hepatitis B surface antigen
with a proprietary Toll-like Receptor 9 agonist to enhance
the immune response.
Engerix-B® 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 higher and earlier protection
with fewer doses than currently licensed vaccines. For more
information visit www.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 www.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
Email Contact
Source: Dynavax Technologies
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