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Pilot Study Demonstrates 50% Survival in Valortim-Treated Animals
PRINCETON, N.J. and ANNAPOLIS, MD., March 29, 2007 - Medarex, Inc. (Nasdaq: MEDX), a leading monoclonal antibody company, and PharmAthene, Inc., a privately held biotechnology company dedicated to the development of biodefense countermeasures, today announced that Valortim, a fully human monoclonal antibody product candidate being developed for the prevention and treatment of anthrax infection, has been shown to have a therapeutic effect in a new primate model of established inhalation anthrax infection.
The new model, which is being developed at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), seeks to improve on existing therapeutic models for anthrax by closely monitoring the disease process to establish the presence of anthrax bacteremia and determine the optimal window for therapeutic intervention. In addition, the new model uses the African Green monkey, which, based on research data, USAMRIID believes follows a similar disease course as is expected in humans exposed to aerosolized Bacillus anthracis spores. B. anthracis is the bacterium responsible for anthrax infection. This new animal model has not yet been validated under the U.S. Food and Drug Administration Animal Effectiveness Rule.
In the pilot study conducted at USAMRIID, adult African Green
monkeys were exposed to aerosolized anthrax spores and blood
samples were collected at regular intervals beginning 24 hours
post-exposure. The samples were closely monitored for evidence of
bacteremia both by culture and by use of a rapid assay designed to
detect protective antigen. Protective antigen is one of the toxins
produced by B. anthracis and its presence in the blood is being
evaluated as a surrogate marker for symptomatic anthrax disease.
Once bacteremia was detected by the rapid assay, animals were
administered either Valortim
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