News Release

Wistar-discovered antibody will help diagnose appendicitis

FDA approval of NeutroSpec™ reflects Philadelphia's biomedical R&D strengths

Business Announcement

The Wistar Institute

(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.

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The Wistar Institute is an independent nonprofit biomedical research institution dedicated to discovering the causes and cures for major diseases, including cancer, cardiovascular disease, autoimmune disorders, and infectious diseases. Founded in 1892 as the first institution of its kind in the nation, The Wistar Institute today is a National Cancer Institute-designated Cancer Center - one of only eight focused on basic research. Discoveries at Wistar have led to the development of vaccines for such diseases as rabies and rubella, the identification of genes associated with breast, lung, and prostate cancer, and the development of monoclonal antibodies and other significant research technologies and tools.

News releases from The Wistar Institute are available to reporters by direct e-mail or fax upon request. They are also posted electronically to Wistar's home page (http://www.wistar.upenn.edu), and to EurekAlert! (http://www.eurekalert.org), an Internet resource sponsored by the American Association for the Advancement of Science.


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