| September
2 , 2004
Dynavax Announces Completion of Enrollment
of Phase II/III Hepatitis B Prophylactic
Vaccine Trial
BERKELEY, Calif., Sept. 2 /PRNewswire-FirstCall/
-- Dynavax Technologies
Corporation (Nasdaq: DVAX), today
announced that it has completed enrollment
and administered the first round of
immunizations in a Phase II/III clinical
trial of its hepatitis B (HBV) prophylactic
vaccine candidate containing Dynavax's
Immunostimulatory Sequence (ISS).
The study conducted at two study centers
in Singapore began enrollment in June.
The double-blind study compared Dynavax's
HBV vaccine candidate with GlaxoSmithKline's
marketed HBV vaccine, Engerix-B(R)
in 94 subjects. The subjects ranging
between 40 and 70 years of age had
not previously been immunized against
HBV. The full immunization schedule
will consist of three injections over
six months, with antibody levels measured
one month after each injection. The
third injection is scheduled to be
administered in early 2005. The primary
endpoint of the study will be comparative
protective antibody levels measured
after the third injection. Comparative
protective antibody levels measured
after the first injection are a secondary
endpoint. The study is being conducted
by Dr. Lim Seng Gee at the National
University Hospital, and Dr. Chow
Wan Cheng, at the Singapore General
Hospital.
"We are pleased with the rapid
enrollment of this study and are on
track
to receive interim results from this
trial early next year," said
Dr. Dino
Dina, President and CEO of Dynavax.
"If these data show that our
HBV vaccine can provide superior protection
against HBV infection for this sizeable
segment of the population that historically
respond poorly to currently marketed
vaccines, we will initiate in the
first half of 2005 phase III studies
that would confirm this efficacy on
a larger scale. In parallel, we will
test this vaccine more broadly in
young adults and adolescents."
Hepatitis B is a common infectious
disease with an estimated 350 million
chronic carriers worldwide. Prevention
of hepatitis caused by the hepatitis
B virus is central to managing the
spread of the disease, particularly
in
regions of the world with large numbers
of chronically infected individuals.
Annual sales of hepatitis B vaccines
in 2001 exceeded $1.0 billion globally.
Currently approved hepatitis B vaccines
confer protective hepatitis B antibody
responses to approximately 95% of
healthy young adults, if the full
dosing regimen is completed. According
to the Centers for Disease Control,
only 53% of all those who received
the first dose of vaccine typically
receive the second dose of vaccine,
and only 30% receive the third, resulting
in greatly impaired protection levels.
Furthermore, the protective hepatitis
B antibody responses achieved by conventional
vaccines is lower in older adults,
and for persons who are overweight
or who smoke.
Data previously reported from Dynavax's
phase II hepatitis B prophylactic
vaccine trial in young adults showed
superior efficacy after both one and
two immunizations as compared to Engerix-B(R).
These results demonstrated that protective
hepatitis B antibody responses were
produced more quickly and withfewer
injections with Dynavax's HBV vaccine.
About
Dynavax Technologies
Dynavax Technologies Corporation discovers,
develops, and intends to commercialize
innovative products to treat and prevent
allergies, infectious diseases, and
chronic inflammatory diseases using
versatile, proprietary approaches
that alter immune system responses
in highly specific ways. Our clinical
development programs 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. In addition
to the hepatitis B vaccine, ISS are
being developed in other indications
that include: a ragweed allergy program
in phase II/III, and an asthma program
in phase II testing.
Dynavax cautions you that statements
included in this press release that
are not a description of historical
facts are forward-looking statements.
The
inclusion of forward-looking statements
should not be regarded as a
representation by Dynavax that any
of its plans will be achieved. Actual
results may differ materially from
those set forth in this release due
to the
risks and uncertainties inherent in
Dynavax's business including, without
limitation, statements about: the
progress and timing of its clinical
trials;
difficulties or delays in development,
testing, obtaining regulatory approval,
producing and marketing its products;
the scope and validity of patent
protection for its products; competition
from other pharmaceutical or
biotechnology companies; its ability
to obtain additional financing to
support
its operations; its ability to maintain
effective financial planning and
internal controls; and other risks
detailed in the "Risk Factors"
section of
Dynavax's Annual Report on Form 10-K
filed on March 30, 2004, and in the
section titled "Additional Factors
That May Affect Future Results"
within
Dynavax's quarterly report on Form
10-Q filed on August 9, 2004. You
are
cautioned not to place undue reliance
on these forward-looking statements,
which speak only as of the date hereof.
All forward-looking statements are
qualified in their entirety by this
cautionary statement and Dynavax
undertakes no obligation to revise
or update this news release to reflect
events or circumstances after the
date hereof.
Contact:
Andrew Gengos Chief Financial Officer
Dynavax Technologies Corporation (510)
848-5100
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