PharmAthene, Medarex receive FDA fast track designation for anthrax antibody

By Angela McDaniels

Seattle, Jan. 9 - Medarex Inc. and PharmAthene Inc. said the Food and Drug Administration has granted fast track designation to Valortim, an investigational antibody designed to protect against inhaled anthrax.

Valortim has been shown in preclinical studies 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, the companies said in a news release. 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 being evaluated in a phase 1 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.

"We believe that Valortim has the potential to play an important role in our nation's biodefense arsenal," PharmAthene president and chief executive officer David P. Wright said in the release.

"Due to its unique mechanism of action with regard to other antibodies, demonstrated efficacy in two animal models and its potency in animal studies at the lowest dose reported, Valortim should be a leading candidate for Project Bioshield procurement."

Valortim targets a protein component known as the anthrax protective antigen of the lethal toxin complex produced by the bacterium. The anthrax protective antigen is believed to initiate the onset of the illness by attaching to cells in the infected person and facilitating the entry of additional destructive toxins into the cells, the companies said.

Initial symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock. Inhalation anthrax is often fatal, even with the use of antibiotics, according to the release.

PharmAthene is a privately held biotechnology company based in Annapolis, Md., that was formed to develop biodefense products.

Medarex is a biopharmaceutical company based in Princeton, N.J., that develops fully human, antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases.

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