Dynavax Initiates First Human Trial of ISS for Asthma
BERKELEY, Calif., May 20 /PRNewswire/ -- Dynavax Technologies, a privately held biopharmaceutical company, today announced it has initiated a Phase I clinical study to evaluate the safety and tolerability of its inhaled ISS (immunostimulatory DNA sequence) for the treatment of asthma. The trial is also designed to produce data on the drug's pharmacokinetics and biological activity as the basis for selecting an appropriate dosage for further development in a Phase II efficacy study. 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. is increasing causing significant impact both in terms of quality of life and in the total costs associated with the disease.
"This trial represents the first use of ISS in a pulmonary delivery mode," said Dino Dina, M.D., president and chief executive officer of Dynavax. "We now have ISS in trials for four disease indications and in each one of them, including hepatitis B, ragweed-induced allergic rhinitis, cancer and asthma, we are using ISS in a different configuration, with the goal of maximizing the therapeutic potential of each intervention."
The randomized, placebo-controlled Phase I safety study will evaluate three dosages of ISS-1018 administered via nebulizer to 54 healthy male volunteers. In Part 1 of the study, administrations will be made weekly for four weeks in each of three groups of subjects. In Part 2 of the study, a single dose will be administered to each of three groups of subjects, followed by tests for biological response markers to ISS-1018. These tests are designed to provide objective measures of activity and potency of the compound in the respiratory tract, and may provide information about mechanisms of action and possible clinical activity in asthmatic patients. The study is being conducted in the United Kingdom, and results are expected by fall 2002. Following the successful completion of this study, Dynavax will conduct a Phase IIa efficacy trial in asthmatic subjects.
Preclinical studies have demonstrated that Dynavax' ISS can reprogram the immune response, reducing inflammatory immune responses provoked by 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 was shown to inhibit airway hyper-reactivity and allergic inflammation.
Asthma is a chronic lung disease characterized by inflammation of the airways typically driven by Th2 lymphocytes in response to common environmental 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.
About Dynavax
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. The company's two most advanced products are AIC, which has provided positive results in recently completed phase II clinical trials for the treatment of ragweed allergy, and a next-generation hepatitis B vaccine that may offer single-dose protection. 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. |
