Jan. 13, 2011
/PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the Company recently presented new data from its anthrax anti-toxin and recombinant Protective Antigen (rPA) anthrax vaccine programs at the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop and the Biomedical Advanced Research and Development Authority (BARDA) Industry Day, held
– 13, 2011 in
"BARDA continues to move forward to work closely with industry in the development and procurement of new medical countermeasures," commented Dr.
, Executive Vice President and Chief Scientific Officer of PharmAthene. "We are delighted to present new data from our biodefense programs, which demonstrate progress towards our shared goal of enhancing biodefense national security initiatives. As the data illustrate, PharmAthene continues to advance its pipeline and further its leadership position in biodefense."
Valortim® Anthrax Anti-Toxin Findings Reported
In an oral presentation entitled,
"Comparison of Functional Activity and Pharmacokinetic Data from Nonclinical Valortim® Efficacy Studies: Implications for the Animal Rule"
, Director of Bioanalytical Assay Development, at PharmAthene presented a biostatistical analysis of pharmacokinetic and toxin neutralization assay results for multiple Valortim
doses in three separate animal species – the African Green Monkey, New Zealand White Rabbit and Cynomolgus Monkey.
In these studies, animals were exposed to anthrax spores and subsequently treated with various doses of Valortim
upon detection of antigenemia (evidence of bacterial infection in the bloodstream) and/or significant increases in body temperature (in the case of New Zealand White rabbits). Pharmacokinetic (PK) analysis of serum samples was conducted utilizing a capture ELISA assay and a toxin neutralization assay (TNA).
Comparisons of the pharmacokinetic and toxin neutralization results for multiple Valortim
doses across the three separate species indicated that the TNA/PK ratios were relatively consistent within individual animals across various time points ranging from five minutes to five days for doses ranging from 2.5 to 40 mg/kg. While the absolute ratios differed slightly for some animals, the consistency of these ratios across time, regardless of dose, species, or animal outcome, suggests the suitability of these assays in providing reliable data to support the Food and Drug Administration's use of the 'The Animal Rule' to approve new drugs or biological products when human efficacy studies are not ethical or feasible.
Dr. Bourdage commented, "Despite the presence of potentially interfering substances in animals with active disease, we're very encouraged that two separate assays evaluating Valortim
concentration and functional activity demonstrated comparable results. In our opinion, this suggests the utility of these assays in providing data to support use of the Animal Rule for the approval of novel medical countermeasures, and thus represents a potentially important advance in the development of monoclonal antibody-based anthrax anti-toxins."
Funding for these studies was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) under contract HHSN27220070033C and by the Department of Defense under contract WB81XWH-07-2-0036.