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April 28, 2003
Palatin Technologies reported positive results from a phase II trial investigating LeuTech, a radiolabeled monoclonal antibody for the detection of pedal osteomyelitis infection in diabetics. Results showed the imaging and detection accuracy of LeuTech was equivalent for subjects both with and without pedal osteomyelitis. Data showed that 10 subjects had a positive diagnosis of pedal osteomyelitis with 15 subjects testing negative for the infection. The study enrolled 25 diabetic subjects with suspected pedal osteomyelitis. The design compared LeuTech with the current standard of care, Indium 111 labeled white blood cells (111IN WBCs) in conjunction with a bone scan. LeuTech technology consists of a direct injection and in-vivo radiolabeling of white blood cells, whereas 111IN WBCs require a blood sample to be taken, labeled in a lab, and then re-injected into the subject.