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PharmAthene Presents rPA Anthrax Vaccine Data at the 2009 HHS PHEMCE Stakeholders Workshop
Date:12/4/2009

s second generation rPA anthrax vaccine, SparVax(TM), is currently under consideration for a major advanced development and procurement contract through BARDA.

PharmAthene's portfolio includes second generation and third generation rPA anthrax vaccine product candidates, which incorporate significant product development and technological advancements and are designed to meet these requirements.

The goal of PharmAthene's third generation rPA vaccine program is to develop a vaccine formulation which can induce a more rapid onset of protective immunity in fewer doses, and can be stored, transported and used without the need for a conventional cold chain -- an important advantage for civilian biodefense deployment within the Strategic National Stockpile.

Summary of the Data Presented

In an oral presentation entitled, "Development of a Highly Stable Lyophilized rPA-Based Anthrax Vaccine," Dr. Duchars presented results from a series of studies evaluating different approaches to increase the stability of an rPA anthrax vaccine product candidate. Of the techniques evaluated, lyophilization showed exceptional stability. An optimized lyophilized formulation of rPA was subsequently tested in an accelerated stability study at 5 degrees C; 25 degrees C; 40 degrees C; and 55 degrees C.

At 3 months, little evidence of rPA degradation was detected in the samples at all temperatures up to and including 55 degrees C. Using the mouse challenge assay, the lyophilized rPA vaccine was shown to have retained potency. Subsequent analysis at 16 months demonstrated that the rPA had retained both structural integrity and vaccine potency.

These preliminary data suggest that an optimized rPA formulation could be used to provide a stable cold-chain-free vaccine. Scale-up of the lyophilization process is currently underway.

Funding for these studies was provided under a Challenge grant (U
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SOURCE PharmAthene, Inc.
Copyright©2009 PR Newswire.
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