ANNAPOLIS, Md., June 14, 2012 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) today announced additional development progress of its next generation rPA anthrax vaccine, SparVax™, which is being developed to provide protection against anthrax exposure during a national security emergency. Following on the successful cGMP manufacturing of SparVax™ at full commercial scale, the Company has now completed final analytical testing and release of the final drug product in pre-filled syringes for future clinical evaluation.
Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer commented, "This latest achievement represents another major step forward for our SparVax™ program. 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."
A key differentiator for PharmAthene's rPA technology platform is the utilization of E. coli. This technology enables a more robust manufacturing process and the capability of annually producing more than 150 million rPA vaccine equivalent doses of bulk drug substance (at a 50 mcg dose) – a substantial improvement in rPA production yield compared to the first generation anthrax vaccine.
PharmAthene's rPA anthrax vaccine program has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority.About PharmAthene, Inc. PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:
- SparVax™ - a second generation recombinant protective antigen (rPA) anthrax vaccine
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
- rBChE - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
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