Dynavax Technologies Corporation's results from a two-year phase 2/3 clinical trial of Tolamba, a ragweed allergy immunotherapeutic, showed that patients treated with Tolamba experienced a statistically significant reduction in total nasal symptom scores (TNSS) compared to placebo-treated patients in the second year of the trial, the primary efficacy endpoint of the study.
Results 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 favourable. Systemic side effects were indistinguishable from placebo and local injection site tenderness was minor and transient, claims a company release.
Based on these results Dynavax anticipates initiating a large-scale pivotal phase 3 clinical trial of Tolamba in the first half of 2006 and pursuing discussions with the US Food and Drug Administration (FDA) concerning the potential registration strategy for Tolamba.
"We believe that the positive outcome in this allergy trial represents a major success for Dynavax and its shareholders and expands our leadership in the TLR-9 agonist space. This achievement provides important validation of our ISS technology's potential to modify disease through immune system reprogramming and complements the positive results shown to date with Heplisav, our hepatitis B vaccine," said Dino Dina, MD, president and chief executive officer.
Dr. Dina added, "We are fully committed to the development of Tolamba and believe this product could represent the cornerstone of our strategy to establish a valuable allergy franchise. We are preparing to initiate our pivotal Phase 3 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. In addition, our ongoing clinical trial in ragweed allergic children is progressing well and should yield primary endpoint results following the 2006 ragweed season. We sincerely appreciate the support and enthusiasm of our many clinical investigators in the phase 2/3 trial, and will look forward to building on these relationships as we implement our pivotal phase 3 trial."
Tolamba represents the foundation of a comprehensive allergy franchise for Dynavax, and has the potential to be a novel entrant in the multibillion-dollar global allergy market. In the US alone, approximately 40 million people suffer from allergic rhinitis. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis, or 30 million Americans. Current therapeutic options are mainly limited to symptomatic therapies and conventional allergy immunotherapy, which generally requires 60-90 shots over three to five years and represents a significant treatment burden for allergy sufferers. Tolamba has the potential to offer a safe, efficacious and convenient alternative for patients suffering from ragweed allergy, added the release.
"The results of the phase 2/3 clinical trial are encouraging, clearly demonstrating that Tolamba has a meaningful clinical benefit in reducing the symptoms of ragweed allergy and has an attractive safety profile. Tolamba could represent an entirely novel approach to allergy immunotherapy and has the potential to offer allergy sufferers with severe as well as moderate or mild disease an effective, convenient and safe alternative to conventional treatment," said Dr. Busse.
Dynavax Technologies Corporation discovers, develops, and intends to commercialise innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways.