PharmAthene and Medarex's Anthrax Drug Fast Tracked
Posted on: Tuesday, 10 January 2006, 12:00 CST
The FDA has granted fast track designation to Valortim, a treatment for anthrax infection being co-developed by Medarex and PharmAthene.
Valortim is an investigational fully human antibody created using Medarex's UltiMAb human antibody development system that targets the bacillus anthracis protective antigen.
The FDA will now facilitate the development and expedite the regulatory review of the product. Fast track designation is given to drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.
Preclinical studies suggest that Valortim has the potential to provide significant protection against anthrax infection when administered prior to the emergence of symptoms of anthrax infection, and also may increase survival when administered therapeutically, or once symptoms become evident.
In these studies, Valortim has been shown to protect both rabbits and monkeys against the lethal effects of anthrax infection when administered at the time of exposure at doses as low as 1 mg/kg. When administered to rabbits after the development of symptoms, Valortim also improved survival as late as 48 hours post-exposure as compared to controls.
Valortim is currently being evaluated in a phase I open-label, dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of a single dose of Valortim administered intravenously or intramuscularly in healthy volunteers.
"The FDA's decision to grant Fast Track designation for Valortim is an important indication of the unmet medical need for novel anthrax therapeutics," commented David Wright, president and CEO of PharmAthene. "We believe that Valortim has the potential to play an important role in our nation's biodefense arsenal."
Source: Datamonitor
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