PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that in addition to its year end results, it will provide an update on the contract modification suspension it received on Friday, March 19, 2010.
PharmAthene is pursuing various options to move forward under the contract modification announced on February 23, 2010 to its existing contract with BARDA for the research and development of SparVax™ pending a final ruling under the protest. The Company is confident that the protest is without merit and that the contract modification will be upheld. While the protest is being resolved, all work under the current contract for the development of SparVax™, including prior modifications, will continue uninterrupted.
Anthrax remains the foremost biological threat to the nation, and the government's Requirement to procure a recombinant anthrax vaccine for the Strategic National Stockpile, which remains unfulfilled, is an important national security priority. The Company continues to believe that SparVax™ represents the most advanced rPA vaccine candidate under development. Phase II human clinical studies suggest that SparVax™ may induce protective immunity in three doses over 56 days whereas the currently licensed vaccine is approved for a 5 dose regimen over 18 months. Various government agencies, including the Institute of Medicine, have acknowledged the urgent need to stockpile next-generation anthrax vaccines employing modern vaccine technology, which offer the potential for improved safety, convenience and more rapid immunity. Further, BARDA has demonstrated its commitment to continued development in this area, through the contract modification and a revision to BAA-BARDA 09-34 to explicitly encourage submissions by recombinant anthrax vaccine developers.
SparVax™ is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for pre and post exposure protection against anthrax infection. SparVax™ is a highly purified, well characterized, sub unit vaccine comprised of a single protein (recombinant PA) manufactured in E.coli. Phase I and Phase II clinical trials involving 770 healthy human subjects have been completed and showed that SparVax™ appears to be well tolerated and immunogenic in humans. These studies suggest that three doses of SparVax™, administered several weeks apart, should be sufficient to induce protective immunity. In non-clinical studies SparVax™ has also demonstrated the capability to protect rabbits and non-human primates against a lethal aerosol spore challenge of the anthrax Ames strain.
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