Emergent BioSolutions, Inc., begins Phase I trial of anthrax vaccine

Emergent BioSolutions, Inc. has initiated a Phase I clinical trial for NuThrax TM, also known as AV7909, which is a third generation vaccine that combines BioThrax with an immunostimulatory compound and adjuvant 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," Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, Inc., said. "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 study, which is a parallel arm dose-ranging study, will evaluate the tolerability, immunogenicity and the safety of the vaccine. It will be performed at multiple U.S. sites and involves 105 health volunteers.

Data from the study is expected be available in the third quarter of 2011.

The trial is being conducted with support from a development contract from the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, and the Office of Biomedical Advanced Research and Development Authority of the Department of Health and Human Services.

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