Dynavax Reports Positive Single-Season Data on AIC Ragweed Allergy Therapy
Dynavax Technologies has announced that data from a Phase I clinical trial of the company's AIC ragweed allergy immunotherapy showed that AIC treatment resulted in a clinically significant improvement in symptoms and a parallel reduction in medication usage during the peak ragweed season compared to placebo.
The Phase I trial was designed to evaluate the safety and immunogenicity as well as to capture selected clinical efficacy parameters of AIC at higher doses than those used in previous studies.
AIC is currently being evaluated in a 462-patient, multisite Phase II/III clinical trial. Pending the outcome of discussions with the FDA in 2005, Dynavax anticipates initiating a pivotal Phase III clinical program in early 2006, and plans to initiate a supportive Phase III trial in a pediatric indication in the first half of 2005.