[CpG-rich DNA conjugates/ragweed/Dynavax]
Saturday March 2, 5:00 pm Eastern Time
Press Release
SOURCE: Dynavax Technologies Corporation
Dynavax, Johns Hopkins University and NIH-Sponsored Immune Tolerance Network Present New Positive Data From Phase II Study of Ragweed Immunotherapy Product (AIC)
NEW YORK, March 2 /PRNewswire/ -- At the 58th annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), Dynavax Technologies Corporation, Johns Hopkins University and the National Institutes of Health (NIH)-Sponsored Immune Tolerance Network announced positive preliminary results from a Phase II clinical trial that assessed the safety, immunogenicity, and clinical efficacy of Dynavax's proprietary anti-allergy immunotherapy known as AIC. AIC consists of the major ragweed allergen, Amb a 1, linked to Dynavax's proprietary 1018 immunostimulatory DNA sequence (ISS).
Johns Hopkins University's Peter Creticos, M.D., the principal investigator for the trial, presented data suggesting that the ISS-enhanced ragweed allergy immunotherapy was well tolerated, immunogenic, and efficacious as indicated by several independent measures of clinical efficacy. The study results showed that individuals who received AIC therapy had substantially lower hayfever nasal allergy symptoms and used less allergy medication during peak ragweed season in comparison to individuals who received placebo. Other measures such as quality of life scores and daily symptom diaries also indicated fewer allergy symptoms among study participants. Additionally, the data showed that the injections of AIC were well tolerated, with the exception of self-limited local reactions, and that no clinically significant, therapy-related adverse events were observed.
Remarking on the outcome, Dr. Creticos said, ``This clinical study represents a major advance in the development of new treatments of allergic disease. Current immunotherapy for allergic rhinitis requires a tedious six-month build-up phase with subsequent maintenance injection therapy over the ensuing 3-5 years to ensure the likelihood of success. This study demonstrates that we can induce a clear clinical response in ragweed allergic patients with a brief six-week, six injection regimen.''
The observer-blind, placebo-controlled Phase II study evaluated 25 adult volunteers who had a history of fall, seasonal allergic rhinitis and exhibited skin test reactions to ragweed pollen. In the study, AIC was administered by subcutaneous injection once per week for six weeks. 19 subjects remained in the study through the period of study immunization and were followed for allergy symptoms, medication use and immune response through the subsequent ragweed season.
``The data reported at AAAAI allows us to move to Phase IIb expanded efficacy studies this summer,'' commented Dino Dina, M.D., Dynavax president and chief executive officer. ``The clinical efficacy data complete the already strong body of positive evidence of AIC's safety and immunogenicity obtained in eight studies involving more than 200 subjects and over 800 AIC injections.''
``The immune response and the safety profile in this clinical study support our goal of developing improved immunotherapy products that will decrease the time required to achieve efficacy, while enhancing patient compliance and ensuring safety,'' stated Dr. Joseph Eiden, vice president of medical affairs at Dynavax.
AIC is an example to Dynavax's proprietary ISS technology linked to a known allergen for presentation to the same part of the immune system at the same time. ISS is a unique short immunostimulatory sequence of single stranded DNA, and it is the foundation technology for Dynavax's proprietary drug development platform. Dynavax believes that the linked molecule generates an increased Th1 response by the immune systems in the form of IgG antibodies and interferon gamma. In both preclinical and earlier human trials, Dynavax has shown that the ISS-linked allergens have a highly specific and potent inhibitory effect of the Th2 cells responsible for allergic reactions. The net effect is to reprogram the immune response away from the Th2 response that causes allergy. Upon subsequent exposure to the allergen, the Th1 memory response is triggered and long-term control of allergy is affected.
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.
The trial was sponsored by the NIH's Immune Tolerance Network (ITN) in collaboration with Johns Hopkins University and Dynavax. ITN is a collaborative clinical research program aimed at accelerating the clinical use of tolerance therapeutics for islet and kidney transplantation, autoimmune disease, and allergy and asthma. Led by over 70 world leaders in the clinical research and basic science of immunology, the ITN is funded by a contract from the National Institute of Allergy and Infectious Diseases; the National Institute of Diabetes, Digestive and Kidney Disease, and the Juvenile Diabetes Research Foundation. The program is headquartered at the University of California, San Francisco.
About Dynavax Technologies
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 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 |
