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news.Emergent BioSolutions, a biopharmaceutical company that develops, manufactures and commercializes vaccines and antibody therapies that support the body's immune system to prevent or treat disease, has started NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant) also known as AV7909 parallel arm dose-ranging Phase I clinical trial.
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With the initiation of the trial, Emergent BioSolutions has dosed first patient in the trial.
According to the company, the Phase I trial is designed to investigate the safety, tolerability and immunogenicity of NuThrax.
Supported by NIH, the Phase 1 trial is being oganised in multiple sites within the US and involves 105 healthy volunteers.
Preliminary data from this study is expected to be available in the third quarter of 2011.
Emergent BioSolutions president and chief operating officer Daniel Abdun-Nabi said that they 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.