Analysis Points to Appropriate Patient Selection Criteria for Future Field
Trial of TOLAMBA
BERKELEY, Calif., Nov. 12 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) presented yesterday a detailed analysis of data from the company's large-scale DARTT (SAR09) trial evaluating TOLAMBA(TM), a novel therapy for ragweed allergic rhinitis. The data were reported yesterday at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Dallas, TX. Dynavax explained that the data extend the company's understanding of the correlation between skin test parameters and the magnitude of ragweed allergic rhinitis symptoms in placebo-treated patients. Specifically, further analysis of the placebo group in the DARTT trial indicated that concomitant use of two parameters of skin test positivity could enable the selection of patients with substantially increased levels of ragweed specific symptoms.
Abstract presenter, Dr. Eduardo Martins, Vice President Clinical Development at Dynavax, indicated, "The DARTT dataset provided an opportunity to assess the correlation between various skin test parameters at enrollment and the development of meaningful symptoms in placebo patients upon exposure to ragweed. This analysis has provided valuable insights to guide the design of a potential future field study of TOLAMBA and increase the likelihood of enrolling symptomatic patients."
Dr. Martins continued, "A pre-specified subset analysis of patients in the Midwest showed a correlation between higher rhinitis symptoms in the placebo group and measurable efficacy in the TOLAMBA-treated group. Data from the current analysis provide additional support for this finding."
The multi-center DARTT study was comprised of 738 subjects with ragweed allergic rhinitis, including 241 placebo subjects. A positive skin test to ragweed was required for enrollment in the study. On January 8, 2007, Dynavax reported that the placebo group overall did not demonstrate sufficient levels of ragweed allergic rhinitis and as a result, no meaningful clinical effect could be measured.
Abstract #31 (ID 385836) entitled, "Wheal and erythema to ragweed extract are distinct predictors of symptom scores in ragweed allergic patients," was part of Concurrent Session "D" on Immunotherapy and Pharmacology.
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 allergic rhinitis caused by ragweed. The linking of ISS to Amb a 1 ensures that both ISS and ragweed allergen are presented simultaneously to the same immune cells, producing a highly specific and potent inhibitory effect and suppressing the Th2 cells responsible for inflammation associated with ragweed allergy.
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists 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. Our product candidates include: HEPLISAV(TM), a hepatitis B vaccine in Phase 3 partnered with Merck & Co. Inc.; TOLAMBA, a ragweed allergy immunotherapy in Phase 2; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinical hepatitis C therapeutic program, and Deerfield Management has committed funding for our allergy programs. While Deerfield, NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.
|SOURCE Dynavax Technologies Corporation|
Copyright©2007 PR Newswire.
All rights reserved