Anthrax vax to move into new Phase II trials

Anthrax is a lethal disease caused by infection with the bacterium Bacillus anthracis. Its spores can lay dormant for centuries, and infection can occur through swallowing or breathing the spores, or even through the skin. These deadly characteristics make it a perfect bioterrorism weapon worthy of a spy thriller. PharmaThene, supported with federal funding, is developing an anthrax vaccine, SparVax, and is planning further Phase II trials for the second half of 2012.

In previous clinical and preclinical trials, SparVax's protection was between 90% and 100% when given on a 6- or 12-month booster dose regime. Thomas Fuerst, executive vice president and CSO commented: "SparVax has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects. This latest Phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax in approximately 300 healthy subjects."

The second-generation recombinant vaccine has been manufactured to full cGMP standards using the company's E. coli-based rPA technology platform, and the trial will use the final drug product in pre-filled syringes. According to the company, this is a major step forward, with a much improved yield and more robust process, compared with the first-generation anthrax vaccine. The vaccine's development is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Biomedical Advanced Research and Development Authority.

The vaccine currently used in the U.S., BioThrax from Emergent Solutions, requires 5 doses over 18 months, with annual boosters. It not clear yet what SparVax's dosing schedule could be, but the company could have an advantage if it is a shorter schedule, or requires fewer doses.

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