Emergent BioSolutions, Inc., announces positive anthrax vaccine trial results

Emergent BioSolutions, Inc., announced results Friday from a Phase 1a clinical trial evaluating an investigational anthrax vaccine.
Anthrax Vaccine Adsorbed, also known as BioThrax, was found to have an accelerated and enhanced immune response when combined with the adjuvant CPG 7909.

The study enrolled 69 subjects who received three doses of either BioThrax alone, one milligram of CPG 7909 alone or BioThrax plus one milligram of CPG 7909. The doses were all given intramuscularly on study days zero, 14 and 28.

Data from the trial shows that BioThrax plus CPG7909 generated peak antibody responses that were six-fold higher than those generated by BioThrax alone. BioThrax plus CPG 7909 also accelerated the time to reach the peak immune response seen following BioThrax vaccination by three weeks.
The findings were determined to be statistically significant. Early immune responses are quite important due to the rapid disease progression of anthrax.
Emergent BioSolutions, Inc., also announced the completion of dosing in its ongoing Phase 1b clinical trial to evaluate the tolerability, immunogenicity and safety of different formulations of BioThrax pre-formulated with a novel immunostimulatory oligodeoxynucleotide compound, which is also known as AV7909 or NuThrax. The company anticipates that preliminary data from that trial will be available as early as Q3 2011.
"Emergent is pleased to share this information related to our anthrax vaccine development program," Daniel J. Abdun-Nabi, the president and chief operating officer of Emergent BioSolutions, Inc., said. "The Phase 1a data on BioThrax plus CPG 7909 add support to our hypothesis that the combination could have enhanced characteristics over BioThrax alone. Such characteristics could increase the attractiveness of this product candidate to potentially support the U.S. government's multi-product strategy in stockpiling medical countermeasures."  
The Phase 1a study was supported by a contract with the Defense Advanced Research Projects Administration. The ongoing Phase 1b trial for NuThrax is being contracted with support that is jointly administered by the National Institute of Allergy and Infectious Diseases and the Office of Biomedical Advanced Research and Development Authority.