FDAnews
www.fdanews.com/articles/75131-phase-i-clinical-trial-of-valortim-announced

PHASE I CLINICAL TRIAL OF VALORTIM ANNOUNCED

August 8, 2005

Medarex and PharmAthene have announced the allowance of an investigational new drug application filed with the FDA to initiate a Phase I clinical trial for Valortim, a monoclonal antibody targeting the bacillus anthracis protective antigen.

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, part of the National Institutes of Health, awarded to Medarex for product development of Valortim as an agent to counter the bioterrorism threat of anthrax exposure.