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April 12, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) announced today that Dr.
Thomas Fuerst, Executive Vice President and Chief Scientific Officer, presented a comprehensive update on the Company's novel SparVax™ rPA anthrax vaccine program at the 2012 World Vaccine Congress, held at the Gaylord National Convention Center in
April 11-14, 2012.
SparVax™ is being developed to meet the government's need for an improved second generation anthrax vaccine that is safe, convenient, more cost-effective, and capable of providing rapid manufacturing scale-up in response to a national security emergency.
New data based on a recent analysis of previous human clinical trial immunogenicity data and non-clinical animal study results for SparVax™ suggested a preliminary estimate of efficacy in humans of over 90% protection and nearly 100% protection based on a 6- and 12-month booster dose, respectively. This analysis is based on a correlate of protection established under the Animal Rule in accordance with FDA guidelines.
"The benefits of rPA-based anthrax vaccines are well established and we believe our program is at the forefront of efforts in this field," remarked Dr. Fuerst. "We are very excited about the progress we continue to make in our SparVax™ program. Beyond our clinical successes, a key differentiator is our robust manufacturing process, which enables production of a highly characterized, highly purified and stable vaccine in sufficient scale required to meet the government's mandate for a modern, second-generation rPA-based anthrax vaccine. We look forward to commencing additional Phase II clinical testing of SparVax™ later this year and to continuing a very productive collaboration with our partners in government to address this important national security requirement."
Dr. Fuerst's presentation also highlighted the important technical milestones that PharmAthene achieved for its SparVax™ program during 2011. These include completing technology transfer of the manufacturing process and cGMP manufacturing of the final drug product at full commercial scale. SparVax™ also demonstrated 36 months of final drug product stability, a particularly noteworthy achievement, as stability has historically been a stumbling block for other rPA vaccine programs. PharmAthene also increased rPA yield six-fold at the bulk drug substance stage, which is highly significant in terms of being able to fill government stockpile requirements.