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Dynavax Initiates Phase II Human Trial Of ISS For ASTHMA First Study of ISS in Asthmatic Patients
Contact:
Dino Dina, M.D.
President and Chief Executive Officer
Dynavax Technologies Corporation
(510) 848-5100
Berkeley, CA, February 11, 2003 � Dynavax Technologies today announced it has initiated an exploratory Phase II clinical trial to evaluate the efficacy of its inhaled ISS (immunostimulatory DNA sequences) for the treatment of asthma. The goal of Dynavax�s ISS therapy is to reprogram the immune response, reducing inflammatory immune responses to allergens and potentially providing long-lasting results. Asthma is a major health problem affecting an estimated 17 million Americans and more than 100 million individuals worldwide. As in other developed countries, the prevalence and severity of asthma in the U.S. are increasing, with significant impact both in terms of quality of life and in the total costs associated with the disease.
�This trial represents the first administration of ISS in asthmatic patients,� said Dino Dina, M.D., president and chief executive officer of Dynavax. �Our Phase I clinical study in healthy volunteers, concluded last fall, demonstrated that the compound is safe and well tolerated when inhaled and gave us objective measures of activity and potency in the respiratory tract. We plan to present this data, including information about mechanisms of action, at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in March.�
Study investigators include Paul O�Byrne, M.D., of the McMaster University Department of Medicine in Hamilton, Ontario, as the principal investigator, and Louis-Philippe Boulet, M.D., of Laval University in Quebec City, Quebec, as co-investigator. The Phase II observer-blind, placebo-controlled trial will evaluate the safety and efficacy of inhaled ISS in 30 patients with allergen-induced asthma. Patients enrolled in the study will receive four inhaled doses of either nebulized ISS or placebo at weekly intervals for four weeks. The primary endpoint of the trial will be a comparison of the change from baseline in late-phase airway responsiveness between ISS and placebo following allergen exposure. Results are expected in the second half of 2003.
ISS are short synthetic DNA sequences that have been shown to strengthen an insufficient immune response against foreign pathogens and cancer, and to suppress an inappropriate immune response against otherwise harmless environmental substances, known as allergens. The first patent covering the use of ISS alone to treat asthma was recently granted to the University of California and is exclusively licensed to Dynavax, giving the company a strong position in the rapidly developing field of ISS treatment for asthma.
Preclinical studies have demonstrated that Dynavax�s ISS therapy can reduce inflammatory immune responses provoked by an over-activation of Th2 cells (T helper type 2 cells) in response to allergens. In numerous mouse and primate studies, ISS delivered to sensitized animals before, during, or after allergen challenge were shown to inhibit airway hyper-reactivity and allergic inflammation.
Asthma is a chronic lung disease characterized by inflammation of the airways typically driven by an excessive Th2 response to allergens. The possibility of inhibiting the inflammation by provoking a concomitant Th1 response provides a strong rationale for developing an ISS-based product for the treatment of asthma. ISS therapy is expected to alleviate the symptoms associated with asthmatic reactions and create mechanisms within the body for preventing future attacks.