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news.Dynavax Technologies has reported that the one-year interim analysis of the company's two-year phase II/III clinical trial of its ragweed allergy therapeutic showed a clear positive trend relative to the trial's major endpoint of nasal symptom scores, as well as other secondary endpoints.
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The interim analysis indicated that AIC was safely administered and systemic adverse reactions were similar between the AIC and control arms.
Dynavax intends to complete the two-year clinical trial as planned, a decision that was endorsed by an independent Drug Safety Monitoring Board. Manufacturing of the phase III clinical supply of AIC will also be completed.
The ongoing 462-patient phase II/III clinical trial, which was initiated in early 2004 and whose primary endpoint is the reduction of nasal symptom scores during the summer/fall 2005 ragweed season, will remain blinded until those data are collected and fully analyzed.
Pending the outcome of discussions with the FDA in early 2005, Dynavax will determine the design, target populations and timing of initiating a pivotal phase III clinical program, now expected to begin in 2006. In addition, Dynavax will discuss with the FDA plans to initiate a supportive phase III trial in a pediatric indication in 2005.
“We believe that the positive trends shown in the AIC phase II/III interim analysis suggest a therapeutic benefit and we are optimistic that the benefit will last, and potentially increase, through the second season,” said Dr Dino Dina, president and CEO.
“This promising outcome, combined with recently reported positive phase II/III interim clinical results with our hepatitis B vaccine, support the clinical rationale for pursuing ISS-based approaches in other allergies such as grass, peanut and cedar, as well as in inflammatory and viral diseases,” Dr Dina added.
In February 2004, Dynavax and UCB Pharma established a strategic partnering agreement for development and commercialization of seasonal allergy products. Dynavax understands that UCB is reviewing its commitment to the program. Should UCB Pharma opt to exercise its contractual right to return the allergy program to Dynavax, Dynavax is planning to pursue the ongoing development of AIC independently.