Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Emergent BioSolutions Inc., today announced the initiation of a Phase I clinical trial for NuThrax^TM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. The product candidate, a third generation vaccine being developed as part of Emergent's anthrax franchise, consists of BioThrax^® (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909.

"Emergent is pleased to commence this clinical trial in support of the U.S. government's multiple product strategy to strengthen the nation's biodefense capabilities," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "We believe this third generation anthrax vaccine has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response, and having a favorable shelf life. If successful, this could be an attractive candidate for the government's growing arsenal of medical countermeasures."

The Phase I clinical trial, a parallel arm dose-ranging study, is designed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the U.S. and involves 105 healthy volunteers. Preliminary data from this study is expected to be available in the third quarter of 2011.