APPY. A miss.
AspenBio Pharma Reports Preliminary Results of AppyScore(TM) Clinical Study
Company to Host Conference Call to Discuss Results on January 22 at 4:30 PM ET
Tuesday January 20, 2009, 9:15 am EST
Yahoo! Buzz Print Related:AspenBio Pharma Inc.
CASTLE ROCK, CO--(MARKET WIRE)--Jan 20, 2009 -- AspenBio Pharma, Inc. (NasdaqCM:APPY - News), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported initial preliminary data from its Food and Drug Administration ("FDA") clinical trial for AppyScore(TM), the world's first blood-based test as an aid in the diagnosis of human appendicitis and an update on planned steps for pursuing FDA market authorization in the U.S.
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Although data analysis is ongoing, the preliminary results demonstrate the relationship between AppyScore and the risk of pathologically proven appendicitis in patients with acute abdominal pain. The company's ongoing data analysis also aims to determine the optimal clinical use of the test in conjunction with other standard diagnostic tests. These preliminary results indicate that the negative predictive value using the previously suggested optimal threshold ("cut-point") of AppyScore at 20 is 83% as compared to 96% that was observed in the earlier pilot study. However, upon further analysis utilizing a lower cut-point a significantly higher negative predictive value is observed. In particular when used in combination with a normal white blood count a negative predictive value of 98% was achieved using an AppyScore cut-point of 15.
"We are encouraged the data from this study continues to support our longstanding belief that AppyScore, in conjunction with other standard diagnostic approaches, could provide a significant improvement in the evaluation of abdominal pain," said Richard Donnelly, president and CEO of AspenBio Pharma. "Along with our FDA consultants we are evaluating our next steps regarding an FDA premarket notification '510(k)' submission to secure clearance as a diagnostic tool as an aid in the diagnosis of acute appendicitis. However, we do not know if the resulting data will be acceptable or sufficient for FDA clearance for our intended use until such determinations are made by the FDA. Furthermore we continue to evaluate the best course of action for the company given our current product plans and objectives. We believe we will be in a position to provide additional information on our FDA 510(k) submission plans and expected timing in the next several weeks."
After elimination of subjects who were determined to not conform to the study criteria, the study encompassed a total of 586 individuals. Of this total 168 (28.7%) had pathology confirmed acute appendicitis. In addition, there were a total of 168 appendectomies (appendix removal surgeries) of which 148 had pathology-confirmed appendicitis. This indicates there were 20 individuals or 12% who had a normal appendix removed and AppyScore correctly identified 10 (or 50%) of these unnecessary appendix surgeries as negative.
The results of the current Pivotal Clinical Study as compared to the results of the prior Pilot Trial are summarized below:
Value, (95% CI) Pivotal Clinical Study Pilot Clinical Study
----------------------------------------------------------------
Statistics Cutoff = 15 Cutoff = 20 Cutoff = 15 Cutoff = 20
------------ ------------ ------------ ------------ ------------
AppyScore:
Negative
Predictive
Value 89% (83-93) 83% (79-87) 98% (89-100) 96% (89-99)
Sensitivity 89% (83-93) 73% (66-79) 98% (86-100) 93% (81-98)
Specificity 38% (33-43) 52% (48-57) 39% (31-48) 54% (46-62)
AppyScore +
WBC(1):
Negative
Predictive
Value 98% (94-99) 93% (89-96) 100% (90-100) 100% (91-100)
Sensitivity 97% (92-99) 85% (77-91) 100% (83-100) 100% (86-100)
Specificity 60% (53-66) 70% (64-75) 54% (43-65) 67% (57-76)
(1) - Limited to the subsets in which the assay determinations
agree (++:--).
The company continues to develop AppyScore and the next generations of the appendicitis test. Based upon preliminary market data reports from two widely recognized market research firms, the market for the emergency room, urgent care and physicians' office may be substantially larger than previously estimated. Additionally, a preliminary pricing and reimbursement study data based upon the features and benefits of a compact electronic reader with 15 minute cassette (which is three times faster than our ELISA test format) suggests that an electronic reader and cassette configuration will result in broader market appeal of the product and likely a significantly higher price. Other indicated benefits over our ELISA include ease of use, better reliability and time to result (15 vs. 45 minutes), reduced sample handling and test preparation steps plus the potential to perform the test in the emergency room and other point of care locations. Significant progress is being made on development of the compact reader and cassette, which includes plans for yes/no, low cost version. Based upon this current assessment, it is unlikely the company will bring an ELISA test format to market. |
