14.06.2005 16:32:00
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New Diagnostic Tool 'Lights Up' Infection for Clinical Certainty in Dangerous Appendicitis Cases
CRANBURY, N.J., June 14 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. announced today that Tyco International , Palatin's strategic collaboration partner that manages the sales, marketing and distribution of NeutroSpec(TM), is conducting a panel discussion today on the use of NeutroSpec in the diagnosis of equivocal appendicitis.
Every year in the U.S. alone, a half million Americans are rushed into the operating room for emergency abdominal surgery. For tens of thousands of them - disproportionately women - they will only later realize it may have been unnecessary. Misdiagnosed appendicitis costs more than $2.4 billion annually in hospital charges, lost time and wages, and medical malpractice lawsuits.
To address this issue, Tyco International today brought together a broad panel of medical and economic experts to outline the problem and describe how a breakthrough imaging agent, NeutroSpec(TM) [Technetium (99m Tc) fanolesomab], can help reduce the human pain and economic cost of misdiagnosed appendicitis.
Carl Spana, Ph.D., president and chief executive officer of Palatin, stated, "We are very excited to continue our successful collaboration with Tyco Healthcare. NeutroSpec(TM) is now available to the entire nuclear medicine community and is positively impacting the diagnosis and management of equivocal appendicitis."
"Every year in the United States, misdiagnosed appendicitis extracts an enormous human and economic toll," said Ed Breen, Tyco Chairman and CEO. "Thousands of patients and their families are affected directly - and it takes a $2.4 billion bite out of our healthcare dollars. Even more shocking, it's preventable. Through our Tyco Healthcare and Mallinckrodt businesses, Tyco now offers technologically advanced products like NeutroSpec to provide physicians with the tools to accurately diagnose patients and improve the quality of patient care everywhere."
NeutroSpec, marketed by Tyco's Mallinckrodt business, is an imaging agent that provides non-invasive, fast, and accurate scintigraphic imaging for patients five years of age or older with equivocal signs and symptoms of appendicitis. It allows physicians to see clearly the "function" of the appendix rather than just the anatomy - resulting in a reliable diagnosis. NeutroSpec attaches to the white blood cells (and myeloid precursors) at the site of the infected appendix, "lighting up" the infection at its source. In the pivotal trial, NeutroSpec was found to be 96 percent accurate in ruling out appendicitis within 90 minutes.
"Even in the 21st century, appendicitis is difficult to diagnose since half of the patients do not exhibit typical symptoms, such as lower right abdominal pain," said Andrew Y. Lo, MD, general surgeon with Beth Israel Hospital. "NeutroSpec provides easy-to-read images that make the diagnosis very clear in as little as 5 minutes for positive cases and no more than 90 minutes in negative cases. This means that greater use of NeutroSpec could result in a dramatic decrease in unnecessary appendectomies."
"During clinical studies, nearly 10 percent of patients with appendicitis would have been sent home - potentially suffering a perforated appendix - if it wasn't for the NeutroSpec scan. This really highlights the need for new diagnostic tools," said Frederick L. Weiland, MD, FACNP, co-director of nuclear medicine at Sutter Roseville Medical Center and clinical associate professor of radiology at University of California, Davis. "NeutroSpec is fast, reliable and easy to read. It truly has the potential to create a paradigm shift in the diagnosis of appendicitis."
Tyco and highly-regarded medical research firm, Covance, unveiled the results of an unprecedented economic study, detailing how misdiagnosed appendicitis cases cost the U.S. close to $2.46 billion yearly in hospital charges, lost wages and medical malpractice lawsuits.
"According to our research study, the rate of misdiagnosis of appendicitis is alarmingly high," said Stacey Ackerman, PhD, vice president of Covance. "Our findings clearly indicate that earlier, more accurate diagnosis would result in substantial clinical and economic benefits."
To educate the general public about the signs and symptoms of appendicitis and other abdominal conditions, as well as to provide useful clinical and diagnostic assistance to physicians, Tyco also launched a consumer/physician Web site - http://www.appendicitisinfo.com/ - at the event. The new Web site provides user-friendly information for parents and other consumers - including interactive diagrams, frequently asked questions, and a glossary of common medical terms. For physicians and other clinicians, the Web site provides a section that details the effectiveness and function of NeutroSpec, important prescribing information, and a handful of patient case studies.
NeutroSpec contains both murine antibodies and sodium hydrosulfite, each of which has been known to induce allergic reactions, including anaphylaxis. The most frequently observed adverse events seen in clinical studies were flushing and difficulty breathing, which occurred in less than 2 percent of patients. For full prescribing information, visit http://www.neutrospec.com/.
About NeutroSpec(TM)
NeutroSpec(TM) is Palatin's proprietary radiolabeled monoclonal antibody product for imaging and diagnosing infections. NeutroSpec is marketed and distributed by Palatin's strategic collaboration partner, Mallinckrodt Imaging, a business unit of Tyco Healthcare. NeutroSpec has been approved by the FDA as an imaging agent for the diagnosis of equivocal appendicitis. The Company is also conducting additional clinical trials with NeutroSpec to evaluate its market potential as an imaging agent for other indications.
NeutroSpec includes a technetium-labeled anti-CD 15 monoclonal antibody which selectively binds to a type of white blood cell, neutrophils, involved in the 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 rapidly image and detect an infection using a gamma camera, a common piece of hospital equipment that records radioactivity. NeutroSpec offers the advantage of direct injection and in-vivo labeling of white blood cells, leading to a rapid and highly specific functional image of an infection in less than an hour, whereas the current standard of care, ex-vivo labeled white blood cells, requires a blood sample to be taken from the patient, processed by a nuclear pharmacy and then re- injected into the patient, with diagnostic images usually not available until 12-24 hours later.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing melanocortin-based therapeutics. The Company has one product on the market generating revenue and a pipeline of product opportunities in development. The Company's internal research and development capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling product development. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. To-date, the Company has formed partnerships with Mallinckrodt, a subsidiary of Tyco Healthcare, and King Pharmaceuticals. For additional information regarding Palatin, please visit Palatin Technologies' website at http://www.palatin.com/.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Palatin disclaims any intent or obligation to update any forward-looking statements. Such statements are based on Palatin's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, the inherent uncertainty associated with financial projections, and such risks and uncertainties as detailed from time to time in Palatin's public filings with the U.S. Securities and Exchange Commission, including but not limited to, Palatin's Annual Report on Form 10-K for the year ended June 30, 2004 and its Quarterly Reports on Form 10-Q for the quarterly periods ended September 30, 2004, December 31, 2004 and March 31, 2005.
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