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May 29, 2014 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP) announced today that new analytical data from the Company's SparVax
® anthrax vaccine program were presented at the 114
th General Meeting of the American Society for Microbiology (ASM), held recently in
In a poster presentation entitled "
Evidence Correlating Changes in Structure and Biological Activity for a Recombinant Protective Antigen (rPA) Anthrax Vaccine," Dr.
Bradford Powell, Director, Analytical Sciences at PharmAthene, presented the Company's achievements in developing new analytical methods to measure how changes in the structural characteristics of rPA impact the potency and stability of the vaccine product, an important requirement for licensure by the United States Food and Drug Administration (FDA). Specifically, deamidation of rPA has been identified as the major pathway of degradation, and methods were developed to assess the state of deamidation over time and its relationship to vaccine potency. The results of the study confirmed a strong positive correlation between the structural and functional stability of rPA.
Peter Fusco, Vice President, Immunobiology and Assay Development for PharmAthene, commented, "Our new analytical assays for this rPA vaccine have yielded faster and more reliable methodology for monitoring the potency and stability of rPA. In fact, we appear to be making considerable progress towards achieving the 'holy grail' for stability-indicating assays, where the chemistry may ultimately be used to predict the biology. As a result, there are now data that we believe demonstrate the product remains potent and stable for at least two years, and subsequent changes are predicted to proceed at a slow rate."
To date, 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.