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news.Medarex and PharmAthene, a privately held biotechnology company dedicated to the development of bio-defense products, have filed an investigational new drug application with the FDA to initiate a phase I clinical trial for Valortim, an antibody with the potential to counter the effects of exposure to anthrax.
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The phase I dose-escalation trial is expected to enroll up to 46 healthy volunteers and is designed to collect safety and pharmacokinetic data. The funding of this clinical trial is supported in large part by a grant from the National Institute of Allergy and Infectious Diseases that is presently awarding grants to company’s to develop anti-bioterrorism agents.
“We are extremely enthusiastic about Valortim’s ability to help the US Government secure effective products to protect the nation’s citizens from biological terrorism,” said David Wright, president and CEO of PharmAthene.
In preclinical studies Valortim has been shown to offer protection to rabbits and monkeys against the normally lethal effects of anthrax infection.