FDA approval of NeutroSpec™ reflects Philadelphia's biomedical R&D strengths
(PHILADELPHIA) - NeutroSpec™, a new imaging agent approved by the Food and Drug Administration for detecting certain difficult-to-diagnose cases of appendicitis quickly and accurately, is based on a monoclonal antibody called SSEA1 discovered at The Wistar Institute. Developed further by Palatin Technologies Inc., located in Cranbury, NJ, with assistance from Thomas Jefferson University, also in Philadelphia, NeutroSpec™ will be marketed by Mallinckrodt Imaging, a St. Louis-based unit of Tyco Healthcare, a global medical products company headquartered in Bermuda.
"The success of NeutroSpec™ reflects the Philadelphia area's enormous strengths in biomedical research and development," says Russel E. Kaufman, M.D., president and CEO of The Wistar Institute. "Contributions from academic scientists at two leading Philadelphia research institutions helped an early-stage biotechnology company in the region and its international corporate partners bring to the clinic an important advance in physicians' ability to diagnose hidden infections."
The Wistar antibody, labeled with radioactive technetium to create NeutroSpec™, binds selectively to the CD15 receptor on neutrophils, a type of white blood cell that travels through the body to sites of infection. When injected into the blood, NeutroSpec™ binds to neutrophils battling an infection, allowing physicians to detect the infection with a gamma camera, a common piece of equipment in hospital nuclear medicine departments.
The FDA approved NeutroSpec™ for use in patients five years of age or older with equivocal symptoms of appendicitis. It is estimated that about half of the 700,000 patients in the United States with suspected appendicitis each year lack distinctive symptoms, such as pain and tenderness in the right lower abdomen, fever, nausea, and an elevated white blood cell count.
NeutroSpec™ enables physicians to rapidly diagnose appendicitis in cases without straightforward symptoms, eliminating the delays and risks, including unnecessary surgeries, associated with current diagnostic capabilities. In Phase III clinical studies of NeutroSpec™, ninety percent of appendicitis cases were diagnosed within an hour.
NeutroSpec™ is also being studied for possible use in diagnosing other occult infections, including osteomyelitis (bone infection), post-surgical abscesses, fever of unknown origin, and inflammatory bowel syndrome. Additionally, NeutroSpec™'s potential as a diagnostic for inhalation anthrax is being investigated.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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