Dynavax Completes Enrollment for Phase 3 Study of HEPLISAV(TM) in Subjects With
Chronic Kidney Disease
BERKELEY, CA, Jan 10, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced completing the enrollment of its Phase 3 study
of HEPLISAV(TM), Dynavax's novel vaccine for the prevention of hepatitis B
infection, in subjects with chronic kidney disease. The multi-center study,
conducted in the U.S., Germany and in Canada, included 69 sites. To date over 500
first immunizations have been administered. According to the protocol, all
patients will receive immunizations over a period of six months, with the primary
endpoint evaluated at month 7. The primary endpoint of the study is
non-inferiority of three injections of HEPLISAV at times 0, 1 and 6 months versus
eight injections of Engerix-B(R) consisting of double doses at times 0, 1, 2 and
6 months.
Tyler Martin, M.D., President and Chief Medical Officer of Dynavax, noted,
"Completion of enrollment in this trial is another important milestone in the
development of HEPLISAV and keeps us on track for BLA submission in Q4 2011. We
expect the last immunizations to be administered in June 2011."
In September, 2010, Dynavax reported that the first subjects enrolled in the
Phase 3 chronic kidney disease study were 12 months past their first dose, and
that no safety issues had been identified by the DSMB monitoring safety of the
trial. The DSMB is comprised of an independent group of medical experts who are
responsible for reviewing and evaluating subject safety data at regular intervals
during the ongoing trials.
In a poster session on Saturday, October 31, 2009 at the 47th Annual Meeting of
the Infectious Disease Society of America (IDSA), Dynavax reported data from two
Phase 2 studies in subjects with chronic kidney disease. Vaccinated with
HEPLISAV, chronic kidney disease patients demonstrated rapid, increased
protection against hepatitis B viral infection in fewer doses than patients
receiving licensed vaccine. 96% of patients (n = 36) receiving 3 doses of
HEPLISAV achieved seroprotection at month 7, compared to 88% of patients (n = 10)
receiving 8 doses of Engerix-B.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate
is being evaluated in two Phase 3 studies that are directed toward fulfilling
licensure requirements in the U.S., Canada and Europe. Enrollment has been
completed for both studies. In a 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 Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six months to
achieve full immunogenicity in healthy patient populations. Because compliance
with this vaccine regimen is low, new vaccines are needed to provide increased
protection with fewer doses in a shorter timeframe. Furthermore, currently
available vaccines do not fully address the needs of several patient populations,
including those with chronic kidney disease, HIV or chronic liver disease. In
particular, patients with compromised immune systems require both rapid and
enhanced protection, either because they are less responsive to conventional
vaccine regimens or because they are at high risk of infection.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious diseases.
The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult
hepatitis B vaccine designed to enhance protection more rapidly and 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, including statements regarding the timing of
the BLA submission. 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 can occur in a timely manner or without significant additional studies
or difficulties or delays in development or clinical trial enrollment, whether
the 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; 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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