FDA OK's Palatin's NeutroSpec

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Palatin Technologies Inc. has received U.S. Food & Drug Administration approval to market NeutroSpec, an imaging agent indicated for the diagnosis of appendicitis in patients five years and older with atypical symptoms. NeutroSpec will be marketed and distributed by Palatin's strategic collaboration partner, Mallinckrodt Imaging, a business unit of Tyco Healthcare.

NeutroSpec, formerly known as LeuTech, includes a technetium-labeled anti-CD 15 monoclonal antibody which selectively binds to a type of while blood cell, neutrophils, involved in immune response. When injected into the blood stream, NeutroSpec binds to neutrophils present at the infection site, labeling these cells with a radioactive tracer. As a result, physicians can image and detect an infection using a gamma camera.

Palatin says it is also conducting additional clinical trials with NeutroSpec to expand its market potential as an imaging agent for other indications such as osteomyelitis, fever of unknown origin, post-surgical abscess, inflammatory bowel disease and pulmonary imaging.