Dynavax Reports Interim TOLAMBA(TM) Ragweed Allergy Results From DARTT Trial
Dynavax Technologies   Corporation (Nasdaq: DVAX) announced today that the analysis of interim   one-year data from its two-year DARTT ragweed allergy trial indicated that  no meaningful ragweed-specific allergic disease was observed in the study  population, making it impossible to measure the therapeutic effect of  TOLAMBA treatment. In all three arms of the study, including the placebo  arm, minimal change from baseline was observed in the main efficacy measure  of the study, the total nasal symptom score (TNSS). The company indicated  that in the placebo and treated groups, the change from baseline TNSS was  very low; not clinically significant; and substantially lower than what has  been observed in prior trials.
     "In effect, we saw three patient groups with no measurable disease  during the ragweed season. This result was unexpected, though these  challenges are well known to occur in allergy drug development. Due to the   fact that no clinically significant disease was seen in the study  population, it was impossible to measure the effect of our intervention,"  noted Dino Dina, MD, president and chief executive officer. Dina continued,  "We are working closely with our consultants and investigators to review  the data in detail and determine the future of the program."
        "In addition to the allergy franchise, we have a diverse pipeline of  TLR9 agonist based programs, including an ongoing pivotal Phase 3 trial  evaluating our hepatitis B vaccine, two clinical cancer studies, and  exciting preclinical work in flu, anthrax, hepatitis, and asthma. Our  partnerships with AstraZeneca, Symphony, and the NIH, and a cash position  in excess of $100 million provide a strong foundation for moving forward to  capitalize on our robust portfolio of near- and longer-term commercial  opportunities," he noted.
        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.
        The DARTT (Dynavax Allergic Rhinitis TOLAMBA Trial) study is a  30-center, placebo-controlled study in 738 ragweed allergic subjects, aged   18 to 55 years. The study randomized subjects into three arms: the same  dosing regimen that was used in the completed Phase 2b trial; a higher  total dose regimen; and placebo. Subjects received six doses of TOLAMBA  over six weeks prior to the start of the 2006 ragweed season.
        About Dynavax
      Dynavax Technologies Corporation discovers, develops, and intends to  commercialize innovative TLR9 agonist-based products to treat and prevent  allergies, infectious diseases, 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  pipeline includes: TOLAMBA(TM), a ragweed allergy immunotherapeutic, for  which a major safety and efficacy trial (DARTT) is currently underway, and  that is in a supportive clinical trial in ragweed allergic children;  HEPLISAV(TM), a hepatitis B vaccine in Phase 3; a therapy for non-Hodgkin's  lymphoma (NHL) in Phase 2; and a therapy for metastatic colorectal cancer  in Phase 1. Our preclinical asthma and COPD programs are partnered with  AstraZeneca. NIH funds our preclinical work on a vaccine for influenza;  Symphony Dynamo, Inc., funds our colorectal cancer trial and our   preclinical programs in hepatitis B and C therapies. While the NIH and  Symphony 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/.
        This press release contains forward-looking statements that are subject  to a number of risks and uncertainties, including statements about our  product candidates, clinical development plans and timelines, business  plans and financial position. Actual results may differ materially from  those set forth in this press release due to the risks and uncertainties  inherent in our business, including difficulties or delays in development;  initiation and completion of clinical trials, the results of clinical  trials and the impact of those results on the initiation or continuation of  subsequent trials, issues arising in the regulatory process; achieving the  objectives of our collaborative and licensing agreements and obtaining  regulatory approval for our products; the scope and validity of patent  protection for our products; possible claims against us based on the patent  rights of others; our ability to obtain additional financing to support our  operations; and other risks detailed in the "Risk Factors" section of our  Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake  no obligation to revise or update information herein to reflect events or  circumstances in the future, even if new information becomes available.
     Dynavax Technologies Corporation
 http://www.dynavax.com/

No comments:
Post a Comment