PharmAthene records development progress with anthrax vaccine

PharmAthene, Inc., an Annapolis, Maryland-based medical countermeasures company, announced on Thursday that its next generation rPA anthrax vaccine has completed final analytical testing and release of the final drug product for further clinical analysis.

SparVax is being developed to give protection against the exposure to anthrax during a national security emergency. The progress the company noted comes after the successful cGMP manufacturing of the vaccine at full commercial scale.

"This latest achievement represents another major step forward for our SparVax program," Thomas Fuerst, the executive vice president and chief scientific officer of PharmAthene, said. "We now know that SparVax manufactured in the United States meets all of the specifications and potency metrics necessary to begin clinical studies. 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."

PharmAthene's rPA technology platform uses E. coli in its manufacturing process, giving it the ability to annually produce more than 150 million rPA vaccine equivalent 50 microgram doses of bulk drug substance. PharmAthene's program for the vaccine was funded in whole or in part with federal funds from the National Institutes of Health, the National Institute of Allergy and Infectious Disease and the Biomedical Advanced Research and Development Authority.

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