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news.PharmAthene has dosed first patient in a randomized, placebo-controlled, double-blind Phase I clinical trial evaluating Valortim as a treatment and prevention of inhalational anthrax.
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The Phase I trial is intended to investigate single escalating doses of 1, 5, or 10mg/kg of Valortim (or placebo) administered intravenously over a 120 minute infusion period.
The company expects to complete the safety follow-up in the third quarter of 2011 with final unblinded results available later in the year.
PharmAthene executive vice president and chief scientific officer Thomas Fuerst said they have completed dosing of all 28 subjects and are pleased to report that no infusion-related adverse reactions have been observed in the current Phase I trial.
"We look forward to completing the Phase I clinical trial, which will provide important information about the IV dosing schedule for Valortim in humans," Fuerst said.