The results from a two-year phase II/III clinical trial of Tolamba, a ragweed allergy immunotherapeutic, showed that patients treated with the drug experienced a statistically significant reduction in total nasal symptom scores (TNSS), the primary efficacy endpoint, compared to placebo-treated patients in the second year of the trial.
Data also showed significant clinical benefit relative to secondary endpoints, including composite hay fever symptoms and ocular effects, and a significant reduction in antihistamine use. These results were achieved after a single short course of therapy prior to the first ragweed season (2004), and demonstrated that a booster dose prior to the second season (2005) was not required to achieve clinical benefit.
Unlike the Tolamba-treated group, the boosted group did not achieve statistical significance relative to the primary efficacy endpoint compared to placebo. The safety profile of Tolamba was favorable. Systemic side effects were indistinguishable from placebo and local injection site tenderness was minor and transient.
Based on these results Dynavax anticipates initiating a large-scale pivotal phase III clinical trial of Tolamba in the first half of 2006 and pursuing discussions with the FDA concerning the potential registration strategy for the drug.
“We are preparing to initiate our pivotal phase III trial within the next few months and will look forward to upcoming discussions with the FDA concerning key parameters in this study and our regulatory strategy,” said Dr Dino Dina, president and CEO at Dynavax.
The company is also continuing with an ongoing clinical trial in ragweed allergic children, results of which are expected after the 2006 ragweed season.