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Feb. 8, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that new pharmacokinetic data from the Company's Valortim® anthrax anti-toxin program were presented at the 9th Annual ASM Biodefense and Emerging Diseases Research Meeting, held in
February 6-9, 2011. The data were presented by Dr.
Elizabeth Leffel, Director of Non-Clinical Sciences for PharmAthene, in a poster presentation entitled,
"Pharmacokinetics of a Monoclonal Anthrax Anti-Toxin Antibody in Healthy and Infected Cynomolgus Macaques."
Valortim® is a fully human anti-toxin monoclonal antibody being developed by PharmAthene for the prevention and treatment of inhalational anthrax. Valortim® was licensed from Medarex, which was acquired by Bristol-Myers Squibb in 2009. Nonclinical animal studies suggest that Valortim® has the potential to provide protection against anthrax infection when administered prophylactically (prior to the emergence of symptoms of anthrax infection) and also may increase survival when administered therapeutically (once symptoms become evident).
"Anti-toxins such as Valortim® are an important part of our nation's biodefense armamentarium against anthrax," commented Dr.
Thomas Fuerst, Executive Vice President and Chief Scientific Officer. "The accumulating data suggest that Valortim® possesses important characteristics that may make it a strong choice for procurement in the Strategic National Stockpile, including: demonstrated efficacy in animal models as both a prophylactic and therapeutic for inhalational anthrax, efficacy at low doses, and a mechanism of action with unique properties that make it an attractive candidate. We look forward to continuing to work collaboratively with the U.S. Government to develop innovative new biodefense countermeasures like Valortim® to protect our nation's citizens both at home and on the battlefield."
Valortim® Findings Reported
The objective of the study was to compare the pharmacokinetics (PK) of Valortim® following a single intravenous injection in non-challenged cynomolgus macaques (cynos) to that in cynos infected with
In this study, 30 healthy non-challenged cynos were given 1, 5, 10, 20, or 40 mg/kg of Valortim® on Day 1. Separately, 48 cynos were challenged with
Bacillus anthracis spores and subsequently given 5, 10, 20, or 40 mg/kg of Valortim® at the time they were determined to be antigenemic (evidence of bacterial infection in the bloodstream).
Serum was collected over 56 days in the non-challenged animals and over 5 days in challenged animals for pharmacokinetics as measured by ELISA. Non-compartmental analysis was conducted on the concentration-time profiles in all cynos.