Emergent BioSolutions Successfully Completes Pivotal Clinical Study

Wednesday, 16 Apr 2014 07:21am EDT 

Emergent BioSolutions Inc:Completes the last licensure-enabling study in its BioThrax((reg))(Anthrax Vaccine Adsorbed) Post-Exposure Prophylaxis (PEP) program.Clinical study, also known as the non-interference study, was designed to evaluate the pharmacokinetic profile of the antimicrobial ciprofloxacin when administered prior to and following the administration of a three-dose series of BioThrax.It was also designed to evaluate the immune response to BioThrax when administered with or without ciprofloxacin.Primary endpoints were the ratio of the maximum concentration (Cmax) and area under the curve (AUC) for ciprofloxacin and the secondary endpoint was the ratio of the geometric mean titer of the antibody response to BioThrax two weeks following the last dose.Study met the prospectively defined success criteria for both the primary and secondary endpoints.Data from this study show no interaction between ciprofloxacin and BioThrax. 

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