Dynavax
Technologies Corporation (Nasdaq: DVAX) announced today the initiation of a
pivotal Phase 3 clinical trial of HEPLISAV, its hepatitis B virus (HBV)
vaccine in Canada. Sites in the United States and in Europe are scheduled
to participate in the study and are expected to begin dosing patients in
early 2007. The multi- center Phase 3 trial, known as PHAST (Phase 3
HeplisAv Short-regimen Trial), will compare a two-dose regimen of HEPLISAV
administered at 0- and 1-month to the conventional three-dose regimen of
Engerix-B(R). The enrollment target of the study is 1,740 subjects, ages 11
to 55 years.
"In several previous clinical studies, HEPLISAV has been shown to
provide seroprotection against hepatitis B faster and with fewer doses than
conventional hepatitis B vaccines. Additionally, HEPLISAV has provided 100%
seroprotection in all fully vaccinated patients, including those who are
difficult-to-treat. We believe our drug's shorter, more convenient
vaccination schedule and proven efficacy position HEPLISAV to significantly
change the standard for HBV adult vaccination. Equally important, the
initiation of the Canadian study sites reinforces our confidence in our
regulatory strategy, and keeps us on track regarding the timing of our
pivotal studies and our plans to file for product licensure," noted Dr.
Eduardo Martins, Vice President, Clinical Development.
Dynavax anticipates that the trial will be completed in 2008 and
intends to use the data to support registration of HEPLISAV. Previously
reported clinical trial results have shown 100% seroprotection after two
doses in subjects 18 to 39 years of age, and after three doses in subjects
40 to 70 years of age. Recently reported data from a Phase 3 study show
that after three doses, HEPLISAV provided seroprotection to 100% of
subjects versus 73.1% for Engerix-B (p < 0.0001), and that after two doses,
HEPLISAV provided seroprotection to 98.5% of subjects versus 25% for
Engerix-B (p< 0.0001).
Dynavax's HBV vaccine is based on its proprietary immunostimulatory
sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to
stimulate an innate immune response. Dynavax's HBV vaccine combines ISS
with HBV surface antigen (HBsAg) and is designed to significantly enhance
the level, speed and longevity of protection. As a result of its
acquisition of Rhein Biotech in April 2006, the company has secured
manufacturing capabilities in Dusseldorf, Germany, for producing both
clinical and commercial quantities of the vaccine.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to
commercialize innovative TLR9 agonist-based products to treat and prevent
allergies, infectious diseases, cancer, and chronic inflammatory diseases
using versatile, proprietary approaches that alter immune system responses
in highly specific ways. Our TLR9 agonists are based on immunostimulatory
sequences, or ISS, which are short DNA sequences that enhance the ability
of the immune system to fight disease and control chronic inflammation. Our
pipeline includes: TOLAMBA(TM), a ragweed allergy immunotherapeutic, for
which a major safety and efficacy trial (DARTT) is currently underway, and
that is in a supportive clinical trial in ragweed allergic children;
HEPLISAV(TM), a hepatitis B vaccine in Phase 3; a therapy for non-Hodgkin's
lymphoma (NHL) in Phase 2; and a therapy for metastatic colorectal cancer
in Phase 1. Our pre- clinical asthma and COPD programs are partnered with
AstraZeneca. NIH funds our preclinical work on a vaccine for influenza;
Symphony Dynamo, Inc., funds our colorectal cancer trial and our
preclinical programs in hepatitis B and C therapies. While the NIH and
Symphony provide program support, Dynavax has retained rights to seek
strategic partners for future development and commercialization. For more
information, please visit dynavax.
This press release contains forward-looking statements that are subject
to a number of risks and uncertainties, including statements about the
potential safety and efficacy of HEPLISAV, whether successful results may
be shown in additional clinical studies, whether HEPLISAV may show similar
or supportive results in the Phase 3 clinical studies and the potential for
HEPLISAV to achieve clinical and commercial success. Actual results may
differ materially from those set forth in this press release due to the
risks and uncertainties inherent in our business, including difficulties or
delays in development, achieving the objectives of our collaborative and
licensing agreements and obtaining regulatory approval for our products;
the scope and validity of patent protection for our products; possible
claims against us on the patent rights of others; competition from other
companies; our ability to obtain additional financing to support our
operations; and other risks detailed in the "Risk Factors" section of our
Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake
no obligation to revise or update information herein to reflect events or
circumstances in the future, even if new information becomes available.
Dynavax Technologies Corporation
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