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September 4 , 2002
Dynavax
Initiates Phase II Clinical Trial
of ISS Vaccine for Hepatitis B
Study
Focuses on Single-Injection Approach
Dynavax
Technologies - BERKELEY, Calif.,-a
privately held biopharmaceutical company,
today announced it has initiated a
Phase II clinical study to evaluate
the ability of its ISS (immunostimulatory
DNA sequence) vaccine candidate to
provide effective hepatitis B prophylaxis
in patients after a single injection.
The study will compare the protective
immune response of patients after
immunization with either Engerix-B(R)
HBV vaccine, a commercially available
hepatitis B vaccine, or recombinant
hepatitis B surface antigen (rHBsAg)
co-administered with Dynavax's proprietary
immunostimulatory DNA sequences (1018-ISS).
Infection
with the hepatitis B virus (HBV) is
a major global health problem, with
350 million chronically infected individuals
worldwide. One third of those with
chronic infection develop cirrhosis
of the liver and/or liver cancer.
"Our ISS vaccine candidate has the
potential to be a single-injection
product that provides protection against
HBV shortly after immunization," said
Dino Dina, M.D., president and chief
executive officer of Dynavax. "Previous
clinical testing suggests its potential
to address major limitations with
current HBV vaccines -- the number
of immunizations required, poor patient
compliance in completing the regimen,
and percentage of non-responders."
As its primary objective, the Phase
II observer-blind, randomized study
will compare the proportions of subjects
achieving seroprotective immune responses
four weeks following the first immunization
with Engerix-B HBV vaccine versus
Dynavax's vaccine, consisting of rHBsAg
and 3 milligrams of 1018-ISS. Additional
immune response comparisons will be
conducted following subsequent immunizations.
Principal investigators for the study
are Simon Dobson, M.D., of the Children
and Women's Health Centre of British
Columbia, and Scott Halperin, M.D.,
of Dalhousie University and the IWK
Health Centre in Halifax, Nova Scotia,
Canada.
Results are expected by late 2002.
Results from a Phase I/II clinical
trial support the potential of the
Dynavax ISS vaccine candidate as a
single-injection product.
The
double blind study compared HBV surface
antigen alone and coadministered with
1018-ISS. At the highest dose tested,
the coadministered vaccine produced
protective antibody titers in 88 percent
of subjects after a single administration,
and all dose levels were well tolerated.
Current commercial vaccines require
up to three injections over a period
of six months to achieve a comparable
level of seroprotection. Development
of a hepatitis B vaccine that provides
rapid protection would be of major
importance in reducing infection,
particularly among high-risk individuals,
including health care workers.
About
Dynavax Technologies
Dynavax Technologies is a privately
held biopharmaceutical company developing
innovative products to treat allergy,
inflammation-mediated diseases, infectious
diseases and cancer. The company’s
lead products are based on ImmunoStimulatory
Sequences (ISS), short DNA sequences
that enhance the ability of the immune
system to fight disease and prevent
inflammation. The company’s two
most advanced products are AIC, which
has provided positive results in recently
completed phase II clinical trials
for the treatment of ragweed allergy,
and a next-generation hepatitis B
vaccine that may offer single-dose
protection. Dynavax is also developing
an oral TNF-alpha synthesis inhibitor
initially for the treatment of rheumatoid
arthritis. The company has collaborations
with Aventis-Pasteur, Triangle Pharmaceuticals
and Stallergenes.
Contact:
Andrew Gengos
Chief Financial Officer
Dynavax Technologies Corporation
(510) 848-5100
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