PharmAthene, Inc. (NYSE MKT: PIP) announced today that new data from the Company's SparVax® next-generation anthrax vaccine program were presented in two separate oral presentations at the 2013 Bacillus – ACT international anthrax conference in Victoria, British Columbia, Canada.
In a presentation entitled "Development of an Immunopotency Assay as a Release and Stability Test for a Recombinant Protective Antigen (rPA) Anthrax Vaccine," Dr. Peter Fusco, Vice President, Immunobiology and Assay Development at PharmAthene, presented data showing the Company's progress in developing a new functional assay to more accurately measure the stability and potency of rPA, an important requirement for licensure by the United States Food and Drug Administration (FDA).
"The issue of stability has historically been a major stumbling block for other recombinant anthrax vaccine programs," said Dr. Fusco. "Current potency assays, such as the Mouse Challenge Assay (MCA), are not optimal due to the inherent variability of infectious challenge assays. There remains a clear need for a more practical and sensitive alternative for potency testing of anthrax vaccines."
Dr. Fusco continued, "PharmAthene has worked closely with the FDA and our partner, the Biomedical Advanced Research and Development Authority (BARDA), to develop more robust assays for anthrax vaccine development. Recently, the FDA advised us that it has accepted the use of our Immunopotency Assay (IPA) as a suitable replacement for the MCA. We are proud to be advancing technologies for next-generation anthrax vaccine development that can provide a superior alternative to existing technologies."
In a second oral presentation entitled "Development of Stability Assays for a Recombinant Protective Antigen Anthrax Vaccine," Dr. Bradford Powell, Director of Analytical Sciences for PharmAthene, presented additional data on the Company's rPA assay development efforts.
The objective of these studies was to evaluate supportive analytical assays to determine the potential correlation between the physicochemical structure and function of rPA. In these experiments, Dr. Powell and his team evaluated the effects of forced degradation of rPA resulting from increases in temperature and pH level. The data showed a trend suggesting a correlation between the structural and functional stability of rPA.
Dr. Powell commented, "By better informing our understanding of how changes to the structure of the rPA molecule impacts its function, or potency, we can fulfill an important requirement of the FDA and provide further confidence in the robustness of our stability data. The continuing refinement of these supportive assays may lead to the development of faster, more cost-effective assays to gauge stability and potency of rPA."
"We are very encouraged about the opportunities for our SparVax® anthrax vaccine program," remarked Eric I. Richman, President and Chief Executive Officer. "The benefits of rPA-based anthrax vaccines are well-established and we believe our program is at the forefront of efforts in this field. Most importantly, SparVax® is expected to meet a fundamental objective of Project BioShield, which was established to encourage the development and acquisition of newer medical countermeasures that offer potential improvements in cost, convenience, safety and effectiveness for the U.S. government and its citizens."
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 BARDA.
SOURCE PharmAthene, Inc.