Emergent BioSolutions Initiates Phase 2 Clinical Trial for Next Generation
Anthrax Vaccine NuThrax
ROCKVILLE, Md. -- January 17, 2013
Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a
Phase 2 clinical trial for NuThrax^TM (Anthrax Vaccine Adsorbed with CPG 7909
Adjuvant), also known as AV7909, with the dosing of the first subject.
NuThrax, a next generation vaccine being developed as part of Emergent's
anthrax franchise, consists of Anthrax Vaccine Adsorbed in combination with a
novel immunostimulatory adjuvant, CPG 7909.
“Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which
supports the near-term goal and priority of the U.S. Department of Health and
Human Services (HHS) to develop next generation anthrax vaccines with advanced
characteristics such as requiring fewer doses and generating an enhanced
immune response,” said Adam Havey, EVP and president of the biodefense
division at Emergent BioSolutions. “We thank HHS for their continued trust and
partnership as we work together to accomplish elements of its Public Health
Emergency Medical Countermeasures Enterprise Implementation Plan set forth to
strengthen the nation’s biodefense capabilities.”
The Phase 2 clinical trial, a randomized, parallel-group, active-controlled,
double-blind study, is designed to evaluate the safety and immunogenicity of
NuThrax for post-exposure prophylaxis of anthrax infection using two and three
dose immunization schedules and two dose levels. The study is being conducted
in multiple sites within the U.S. and plans to enroll 168 healthy adult
volunteers. Preliminary data from this study are expected in the fourth
quarter of 2013.
Emergent has submitted to the U.S. Food and Drug Administration the Clinical
Study Report for the Phase 1 study, which evaluated the safety and
immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection
using a two dose immunization schedule and four formulations.
This Phase 2 clinical trial is being conducted with support from the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH) of HHS, under development contract number
HHSN272201000035C. The Phase 1 trial was conducted with support from a
development contract jointly administered under contract number
HHSN272200800051C by NIAID and the Office of the Biomedical Advanced Research
and Development Authority (BARDA), a component of the Office of the Assistant
Secretary for Preparedness and Response (ASPR), HHS.
About Emergent BioSolutions
Emergent BioSolutions is a specialty pharmaceutical company seeking to protect
and enhance life by offering specialized products to healthcare providers and
governments to address medical needs and emerging health threats. Additional
information may be found at www.emergentbiosolutions.com. Follow us on
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Emergent BioSolutions Inc.
Robert G. Burrows
Vice President, Investor Relations
Vice President, Corporate Communications
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