Study Demonstrates AspenBio Pharma’s AppyScore Multi-Marker Blood Test Highly Predictive for Absence of Acute Appendicitis in Children with Abdominal Pain
Clinical Data to be Presented at Annual Meeting of the Society for Academic Emergency Medicine
Feb 28, 2012
CASTLE ROCK, Colo., Feb. 28, 2012 — The final results from AspenBio Pharma’s (NASDAQ: APPY) 503-patient pilot study of AppyScore™ will be presented from the podium at the annual meeting of the Society for Academic Emergency Medicine being held in Chicago, May 9-12.
AppyScore is a multi-marker blood-based test panel consisting of the company’s patented MRP 8/14 biomarker and C-reactive protein, along with white blood cell count. AppyScore is designed to aid emergency physicians in the identification of patients at low risk when acute appendicitis is suspected due to abdominal pain. The AppyScore test is in development and not yet approved for use. Abdominal pain is the number one reason for hospital emergency department visits, and appendectomy is the number one reason for emergency abdominal surgery.
Enrollment and delivery of the total patient samples for the 2011 pilot study was completed in December 2011, and included pediatric and adolescent patients ages 2-20 with symptoms suspicious for acute appendicitis who were enrolled at 11 hospital sites across the country. Final data analysis using the multi-marker panel on the total 503 patient samples collected in the 2011 pilot study was recently finalized and demonstrated results for the AppyScore test at a negative predictive value of 97%, sensitivity of 96%, and specificity of 43%.
"Evaluating children for appendicitis is difficult, and strategies have been sought to improve the precision of the diagnosis,” said David S. Huckins, M.D., a clinical investigator in the AppyScore pilot study. “Computed tomography (CT) is widely used, but there are concerns regarding the large dose of ionizing radiation and risk of subsequent radiation-induced malignancy. I believe that the AppyScore results demonstrated in this study are very encouraging.”
In the U.S., approximately 10 million people annually enter hospital emergency rooms with abdominal pain. Currently, CT scanning is frequently used for screening of appendicitis due to the lack of other more definitive tools. However, CT scans take time, are expensive, and published studies have reported increased concern among clinicians about the potential harmful effects of CT radiation.
According to the New England Journal of Medicine, children are at significantly greater risk from CT scans because they are inherently more radiosensitive and have more remaining years of life during which a radiation-induced cancer could develop. A single abdominal CTscan exposes patients to a radiation dose equivalent to 100 to 800 chest x-rays, according to a February 2010 report released by the FDA, “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.”
“The use of AppyScore has the potential to reduce the number of costly abdominal CT scans and associated exposure to harmful radiation,” said Stephen T. Lundy, president and CEO of AspenBio Pharma. “In addition, radiology procedures can result in significant wait times and patient backlog in hospital emergency rooms. These factors have created an unmet clinical need for a quick blood test that can provide doctors with a high level of confidence that low-risk patients may be conservatively managed and potentially not require CTscans in the workup for possible appendicitis.”
An AppyScore pivotal clinical trial is planned for later in 2012, followed by the submission of results to the U.S. Food and Drug Administration for market clearance. The company is also advancing in plans to certifyAppyScore with the CE (European Conformity) mark, allowing for the potential sale and distribution ofAppyScore in regions of Europe before the end of the year.
About AspenBio Pharma and AppyScore
AspenBio Pharma, Inc. is an emerging in vitro diagnostic company focused on obtaining FDA clearance for its lead product, AppyScore, which is a unique blood-based test in development designed to help physicians manage the large number of patients who enter emergency rooms every year complaining of abdominal pain, many suspected of having acute appendicitis. As a screening test to aid in evaluating patients suspected of appendicitis based on its projected sensitivity and negative predictive value, the AppyScore test is designed to aid in identifying those patients who are at low risk for appendicitis, allowing clinicians to take a more conservative approach to patient management. The current focus of AspenBio’s effort is the use of AppyScorein children and adolescents suspicious for the disease as this population is at the highest risk of the long-term health effects associated with CT imaging. AppyScore could potentially decrease radiation exposure risk arising from the use of CT scans performed in triaging pediatric and adolescent patients with abdominal pain, as well as potentially reduce healthcare costs. The company has a large and unique repository of blood samples that provide valuable data regarding the appendicitis condition and additional protein marker information associated with causes of abdominal pain, providing an important resource for product development. For more information, visit www.aspenbiopharma.com.
This press release includes "forward-looking statements" of AspenBio Pharma, Inc. ("AspenBio") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this press release that address activities, events or developments that AspenBio believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors AspenBio believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of AspenBio. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product modifications in a timely and cost effective manner, complete clinical trial activities for AppyScore required for FDA submission, obtain FDA clearance, cost effectively manufacture and generate revenues from AppyScore and other new products, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, AspenBio does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this press release should be considered in conjunction with the risk factors contained in AspenBio's recent filings with the SEC, including its Quarterly Report on Form 10-Q for the period ended September 30, 2011.
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