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Abstract presenter, Dr. Eduardo Martins, Vice President ClinicalDevelopment at Dynavax, indicated, "The DARTT dataset provided an opportunityto assess the correlation between various skin test parameters at enrollmentand the development of meaningful symptoms in placebo patients upon exposureto ragweed. This analysis has provided valuable insights to guide the designof a potential future field study of TOLAMBA and increase the likelihood ofenrolling symptomatic patients."
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Dr. Martins continued, "A pre-specified subset analysis of patients in theMidwest showed a correlation between higher rhinitis symptoms in the placebogroup and measurable efficacy in the TOLAMBA-treated group. Data from thecurrent analysis provide additional support for this finding."
The multi-center DARTT study was comprised of 738 subjects with ragweedallergic rhinitis, including 241 placebo subjects. A positive skin test toragweed was required for enrollment in the study. On January 8, 2007, Dynavaxreported that the placebo group overall did not demonstrate sufficient levelsof ragweed allergic rhinitis and as a result, no meaningful clinical effectcould be measured.
Abstract #31 (ID 385836) entitled, "Wheal and erythema to ragweed extractare distinct predictors of symptom scores in ragweed allergic patients," waspart of Concurrent Session "D" on Immunotherapy and Pharmacology.
About TOLAMBA
TOLAMBA consists of Dynavax's proprietary immunostimulatory sequences(ISS) linked to the purified major allergen of ragweed, called Amb a 1.TOLAMBA is designed to target the underlying cause of seasonal allergicrhinitis caused by ragweed. The linking of ISS to Amb a 1 ensures that bothISS and ragweed allergen are presented simultaneously to the same immunecells, producing a highly specific and potent inhibitory effect andsuppressing the Th2 cells responsible for inflammation associated with ragweedallergy.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends tocommercialize innovative TLR9 agonist-based products to treat and preventinfectious diseases, allergies, cancer, and chronic inflammatory diseasesusing versatile, proprietary approaches that alter immune system responses inhighly specific ways. Our TLR9 agonists are based on immunostimulatorysequences, or ISS, which are short DNA sequences that enhance the ability ofthe immune system to fight disease and control chronic inflammation. Ourproduct candidates include: HEPLISAV(TM), a hepatitis B vaccine in Phase 3partnered with Merck & Co. Inc.; TOLAMBA, a ragweed allergy immunotherapy inPhase 2; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and formetastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also inPhase 1. Our preclinical asthma and COPD program is partnered withAstraZeneca. The National Institutes of Health (NIH) partially funds ourpreclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) fundsour colorectal cancer trials and our preclinical hepatitis C therapeuticprogram, and Deerfield Management has commit
