"We are pleased to have been able to refine this model for therapeutic intervention in anthrax infection, further defining the potential efficacy of Valortim in anthrax disease," commented Dr. Lowy. "Animal modeling for therapeutic intervention in anthrax infection (in contrast to post-exposure prophylaxis) has been challenging because of the variability in onset time to disease after exposure and the rapidity of disease progression once symptoms are manifest. We used a rapid approach to identify animals with active disease, and our results showed that the animals designated for treatment proved to have bacteria circulating in their blood, supporting the accuracy of the approach and that Valortim had impressive activity in this setting. This study, along with others being conducted by our partner PharmAthene, may help to define an optimal and reproducible approach to evaluate therapeutic agents for anthrax disease in general, as well as Valortim in particular."
Details of the study
The pilot study, funded by the National Institute of Allergy and
Infectious Diseases, part of the National Institutes of Health (NIH), was
designed to attempt to refine the New Zealand White (NZW) rabbit model as a
predictive therapeutic model for anthrax inhalation disease, and to assess
the efficacy of Valortim in this model. In the study, 32 adult NZW rabbits
were exposed by aerosol to Ames anthrax spores. Beginning 12 hours
post-exposure, animals were evaluated hourly for changes in temperature,
and every 6 hours blood samples were collected to assess bacteremia and
protective antigen in blood. Samples were analyzed for protective antigen
via a rapid electrochemiluminescent immunoassay (ECL), and bacteremia was
evaluated by 24- hour culture. A significant increase in body temperature
|SOURCE Medarex, Inc.|
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