A method to detect the earliest stages of inhalation anthrax infection will soon undergo a clinical trial to assess its efficacy.
As reported in the December issue of The Journal of Nuclear Medicine, researchers at Walter Reed Army Medical Center in Washington will assess the efficacy of a technetium Tc 99mlabeled monoclonal antibody for imaging early-stage inhalation anthrax infection. The technique promises to detect the earliest stages of infection before any other laboratory or radiographic diagnostic test and well before serious symptoms of the infection are apparent.
The trial is designed to identify asymptomatic patients who experience "credible exposure" to anthrax spores. For ethical reasons, all patients exposed will be assessed with no control group since time-from-exposure is a key factor in the successful treatment of pulmonary anthrax. The trial will enroll subjects on active military duty, their spouses, or retired service members.
The monoclonal antibody works by binding with high affinity and specificity to a carbohydrate antigen, CD-15, on human polymorphonuclear leukocytes in vivo. This means that once a small amount of the radiolabeled antibody is injected, it binds to white blood cells congregating at the site of even the earliest infections, making them apparent on nuclear medicine imaging.
An investigational new drug designation was granted to Palatin Technologies, which makes Leutech, the radiolabeled antibody product that will be used in the investigation.