| June
24 , 2004
Dynavax Completes Phase I Immunization
in Pediatric Ragweed Allergy Trial
FOR IMMEDIATE RELEASE
BERKELEY, Calif., June 24 /PRNewswire-FirstCall/
-- Dynavax Technologies
Corporation (Nasdaq: DVAX), a biopharmaceutical
company focused on the
discovery, development, and commercialization
of innovative products to treat
and prevent allergies, infectious
diseases and chronic inflammatory
diseases,
today reported the successful completion
of immunizations in a Phase I
pediatric trial of its ragweed allergy
immunotherapy product candidate, AIC.
Only relatively minor and transitory
local reactions at the injection site
were reported, and no dose adjustments
were necessary.
"The local reactions and adverse
experience of AIC in this young
population appeared to be even milder
than those observed in the adult
population, where the product has
already been shown to be quite safe
and well
tolerated," said Dino Dina, M.D,
President and Chief Executive Officer
of
Dynavax Technologies.
"The excellent tolerability
of AIC thus far in the pediatric age
group
provides us with the ability to evaluate
AIC in a larger segment of the target
ragweed allergic population. Equally
important, we believe these findings
could permit us to explore early interventions
with AIC in ragweed allergic
individuals prior to the onset of
severe symptoms and the development
of
asthma, with the goal of preventing
the evolution of the disease into
significant health and life-style
compromising conditions. We hope in
the
future to test AIC therapy as a way
to prevent the onset of severe allergic
disease their serious sequelae such
as chronic sinusitis and asthma,"
Dr. Dina
added.
The pediatric trial is being conducted
in 24 children between the ages of
9 and 17 with known ragweed allergy,
as documented by medical history and
a
strongly positive skin test to ragweed
allergen. Subjects were subdivided
into
three cohorts, with each cohort receiving
gradually increasing doses of AIC.
The pediatric trial
is part of Dynavax's larger AIC ragweed
program being
conducted in collaboration with Dynavax's
partner, UCB Pharma. The AIC
program includes an ongoing Phase
II/III study in adults, with a blinded
interim analysis to be made in late
2004 to assess safety and the
appropriateness of commencing a one-year
Phase III trial in early 2005.
About UCB Pharma
UCB Pharma
is one of Europe's leading pharmaceutical
companies. It is
active in all the world's major markets,
specializing in the fields of allergy
and respiratory diseases and in treatments
for disorders of the central
nervous system. Among products
developed by UCB Pharma are XYZAL(R)
(levocetirizine), a novel antihistamine;
ZYRTEC(R) (cetirizine hydrochloride),
the world's most widely used second-generation
antihistamine; and KEPPRA(R)
(levetiracetam), a novel adjunctive
therapy for the treatment of partial
onset
seizures associated with epilepsy.
ZYRTEC(R) is a registered trademark
of
Pfizer, which markets ZYRTEC(R) in
the U.S. under an agreement with UCB.
With
over 6,500 employees and operating
in over 100 countries, UCB Pharma's
global
headquarters are in Brussels, Belgium.
In 2003 it achieved a consolidated
turnover of euro 1,463 million.
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
Note: This press
release contains "forward looking
statements" within the meaning
of the federal securities laws. These
forward-looking statements include
without limitation, statements relating
to the potential success of product
development, subsequent regulatory
approvals and potential product sales.
These statements are subject to risks
and uncertainties that could cause
actual results and events to differ
materially from those anticipated.
Readers are cautioned not to place
undue reliance on these forward-looking
statements that speak only as of the
date of this release. Dynavax undertakes
no obligation to update publicly any
forward-looking statements to reflect
new information, events or circumstances
after the date of this release except
as required by law.
|
