Dynavax Reports Positive Immunogenicity Data From an Analysis of Hypo-Responsive
Populations in HEPLISAV(TM) Phase 3 Trial
BERKELEY, CA, Oct 10, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced immunogenicity data for subpopulations known
to be hypo-responsive (males, obese, and smokers) to currently licensed hepatitis
B vaccines from its Phase 3 trial (HBV-16). The Phase 3 study was a multi-center,
observer-blinded study to determine if the immunogenicity of two doses of
HEPLISAV was non-inferior/superior to three doses of Engerix-B(R) by comparing
seroprotection rates (SPR) at eight weeks post last dose in healthy adults over
age 40.
The data demonstrate HEPLISAV's enhanced immune response and superiority as
measured by peak SPRs for the subpopulations as follows:
HEPLISAV SPR%Engerix-B SPR%
---------------------------
Adults = 40 yrs.95.170.5
Males94.667.8
Females95.677.8
Obese (BMI = 30 kg/m2)94.765.4
Non-obese95.478.4
Smokers95.665.3
Non-smokers95.074.8
As reported previously, for all safety parameters, HEPLISAV was similar to the
Engerix-B control arm.
Dynavax President and Chief Medical Officer, Tyler Martin, MD, said, "These
subset analyses from HBV-16 further underline the superiority of HEPLISAV
compared to the current market leading HBV vaccine, Engerix-B. It has long been
known that males, the obese, and smokers have an impaired response to current
licensed HBV vaccines. Not only was HEPLISAV superior to Engerix-B in each of
these subpopulations, the seroprotection rates in the HEPLISAV group did not
decline for any hypo-responsive subset, in comparison to the responsive subset.
These results substantially strengthen the observation that HEPLISAV is superior
to Engerix-B."
Dynavax will present additional detail on the hypo-responsive groups at the
American Association for the Study of Liver Diseases (AASLD) later this year.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier completed
pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with
fewer doses than current licensed vaccines. Dynavax has worldwide commercial
rights to HEPLISAV and is developing the vaccine for large, high-value
populations that are less responsive to current licensed vaccines, including
individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface
antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance
the immune response.
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," 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 the outcome of
pre-filing discussions with regulatory authorities; 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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