Tuesday March 20, 8:31 am Eastern Time
Press Release
SOURCE: Dynavax Technologies Corporation
Dynavax Presents Phase II Results for Ragweed
Immunotherapy (AIC) At American Academy of
Allergy, Asthma and Immunology (AAAAI) Meeting
NEW ORLEANS, March 20 /PRNewswire/ -- At the 57th annual meeting of the American
Academy of Allergy, Asthma and Immunology, Dynavax Technologies Corporation
announced preliminary results from a Phase II clinical trial that demonstrated the safety and
immunogenicity of a short-course form of immunotherapy for ragweed allergy.
The Phase II study, presented by Joseph Eiden, M.D., Ph.D., vice president of medical
affairs at Dynavax, explored the safety and immune response, or immunogenicity, of
Dynavax's AIC in a pool of 27 ragweed-allergic adults with a history of seasonal rhinitis, or
hay fever. AIC is an anti-allergy vaccine candidate composed of the major ragweed allergen,
Amb a 1, linked to Dynavax's proprietary 1018 immunostimulatory DNA sequence (ISS). In
the study, AIC was administered subcutaneously in a six-injection regimen at three different
dosing levels, ranging from 2.4 micrograms over a three-week period to 15 micrograms over
a six-week period. The study was sponsored by Stallergenes, S.A., Dynavax's collaborator
in Europe for AIC, and was conducted at the Centre Hospitalier in Lyon Sud, Lyon, France,
with Professeur Denis Vital Durand and Dr. F. Dieudonne as principal investigators.
Study results demonstrated that the injections of AIC were well tolerated, with the exception
of self-limited local reactions. No serious, vaccine-related adverse systemic reactions were
observed throughout the study. Antibody responses to ragweed allergen showed marked
dose-related increases in allergen-specific IgG levels. These levels were similar to those
observed with successful conventional immunotherapy (allergy shots) with licensed ragweed
extract -- an approach that typically involves 60 injections of allergen administered at
frequent intervals over a period of up to two years. Elevated levels of IgG against the allergen
are reported to be associated with successful immunotherapy.
``These preliminary results show that AIC, administered over a six-week period, can induce
an antibody response similar to that of conventional immunotherapy, administered over a
period of years,'' stated Dr. Eiden. ``This immune response and the safety profile in this
clinical study therefore support our goal of developing improved immunotherapy products
that may decrease the time required to achieve efficacy, while enhancing patient participation
and ensuring safety. Our next step will be to proceed to Phase II/III testing of AIC in the
near future.''
Also at this year's AAAAI meeting, Dr. Peter Creticos reported results obtained in another recently completed study with AIC,
conducted at Johns Hopkins University. The Hopkins study explored safety and immune response to AIC, using a schedule of
subcutaneous immunotherapy injections similar to that employed for conventional immunotherapy regimens with licensed
allergen vaccines in the U.S. In this study, AIC exhibited a safety profile and immune response similar to that observed in the
study in France.
At last year's AAAAI annual meeting, Dr. Creticos presented a Phase I clinical study demonstrating that AIC is less allergenic
than conventional ragweed pollen extracts currently used in immunotherapy. In that study, an average of approximately
180-fold more AIC was required to induce a skin test allergic response equal to that of licensed ragweed alone. These data
indicated the potential for improved safety of AIC for immunotherapy.
Allergic rhinitis, or hay fever, is the fifth most prevalent chronic disease in the U.S., affecting more than 40 million people and
resulting in an estimated 9.2 million physician visits each year. The majority of allergic individuals suffer seasonal symptoms in
response to airborne pollens produced by weeds, grasses and trees. In the U.S., ragweed is reported as the most prominent
among the seasonal allergens, affecting an estimated 20 to 30 million people. AIC is the first in a series of ISS-allergen
conjugate products that Dynavax plans to develop for the treatment of allergic rhinitis caused by seasonal and perennial
allergens.
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. Dynavax's lead product, AIC, has recently completed Phase II clinical testing for the treatment of
ragweed allergy. 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. A company profile
is available at the Dynavax website, www.dynavax.com.
SOURCE: Dynavax Technologies Corporation |
