( inistered either Valortim or saline (co...)Anthrax Monoclonal Antibody Valortim Demonstrates Therapeutic,Effect in New Primate Model of Established Anthrax Infection,Health

"While post-exposure models of inhalation anthrax infection are relatively straight-forward, demonstrating efficacy in a therapeutic model for inhalation anthrax infection has proven somewhat challenging," remarked Valerie Riddle, M.D., Vice President and Medical Director for PharmAthene. "In most animal species in which anthrax has been studied, the disease course and time to death is markedly shorter than that seen in humans, making it challenging to evaluate the potential therapeutic efficacy of promising products. The model being developed by USAMRIID uses a rapidly detectable surrogate marker for the development of symptomatic disease to provide a consistent window in which to determine the therapeutic efficacy of Valortim in animals confirmed to have active disease. We believe this will be an important consideration for the licensure of novel anthrax therapeutics under the Food and Drug Administration's proposed Animal Rule."

Dr. Riddle continued, "This is a very encouraging survival result when one considers that these animals had bacteria multiplying in their blood and were poised to manifest severe symptoms and death at the time they were treated with Valortim. We plan to continue to collaborate with USAMRIID to further refine the model and determine the optimal therapeutic dose for Valortim."

"Previous studies in the rabbit animal model had suggested the capacity of Valortim to successfully treat symptomatic animals," noted Israel Lowy, M.D., Ph.D., Senior Director of Infectious Disease for Medarex. "The current studies in a non-human primate model, that may be more relevant to human disease, provide additional confirmation for those results. The methodological advances of the group at USAMRIID may help to better define the therapeutic potency of Valortim and
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