Navigation Links
Dynavax Presents New Analysis of TOLAMBA(TM) Data at ACAAI Meeting
Date:11/12/2007

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.

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 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.

About Dynavax

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

Related medicine technology :

1. Dynavaxs HEPLISAV(TM) Hepatitis B Vaccine Maintains Full Immunogenicity at 50 Weeks in Phase 3 Trial
2. Dynavax Begins TOLAMBA(TM) Environmental Exposure Chamber Study
3. Genaera Corporation Presents Interim Phase 1 Data for Obesity Compound Trodusquemine (MSI-1436) at IBC Conference
4. EntreMed Presents Data for Phase 2 Study of MKC-1 in Metastatic Breast Cancer
5. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
6. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
7. CEL-SCI Presents Data for CEL-1000 as a Vaccine Adjuvant with Recombinant Hepatitis B Virus Protein
8. Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
9. Targanta Presents First Data Demonstrating In Vitro Activity and In Vivo Efficacy of Prodrugs in Osteomyelitis Models
10. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
11. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... has announced the addition of the " Global ... This report ... provides an updated review, including its applications in various ... total market, which includes three main industries: pharmaceutical and ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, 2016 ... mobile pulmonary function testing company, is now able to perform sophisticated ... by ndd Medical Technologies , Inc. Patients ... hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients ... get any needed testing done in the comfort of her own ...
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... Quality metrics are proliferating in cancer care, and are derived from many ... the beholder, according to experts who offered insights and commentary in the current issue ... the full issue, click here . , For the American Society of Clinical ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... A recent ... that most people are unfamiliar with. The article goes on to state that individuals ... also many of these less common operations such as calf and cheek reduction. The ...
(Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are recognized ... this recognition are considered among the top 2 percent of lawyers practicing within the ... this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, Burt ...
Breaking Medicine News(10 mins):