AspenBio Pharma (APPY) Updates on Progress and Plans of ELISA Appyscore Test 510(k) Submission
AspenBio Pharma, Inc. (NASDAQ: APPY) reported on its progress and plans for the Premarket Notification 510(k) submission of its ELISA format AppyScore test. AppyScore is the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis.
The previously announced AppyScore supplemental clinical trial continues to advance, with over 400 patients enrolled to-date from the emergency departments of more than a dozen well-known hospitals across the United States. Based upon additional analysis of prior trial data, as well as input from a panel of clinical experts assembled by AspenBio's regulatory consultants, the Statistical Analysis Plan ("SAP") for this supplemental trial has now been finalized. This SAP defines a study end point for the AppyScore test alone, and additionally, adds two alternative end points which evaluate the AppyScore result in combination with either white blood cell count ("WBC") or neutrophil count.
Applying the parameters of this SAP in a retrospective analysis of the previous pivotal clinical trial data improved the negative predictive value ("NPV") of AppyScore to more than 95% in the subset of patients who have negative results for either the combination of AppyScore/WBC or AppyScore/neutrophil count. While there can be no absolute assurance that these results will be repeated in the current supplemental clinical trial, the company believes such results, if repeated would substantially enhance the clinical utility and value of AppyScore in the emergency department setting.
The SAP provides for, and AspenBio has scheduled, an interim analysis of the clinical trial data to validate the required supplemental trial sample size necessary to achieve statistical significance for all study endpoints. Achieving statistical significance is essential for the inclusion of these important study end points in the submission of the Premarket Notification 510(k) information to the FDA, as well as describing clinical utility to physicians. This interim analysis was initially planned to be conducted with data from 250 patients; however, with the addition of the two new alternative study end points, a 400 patient interim data analysis will provide better predictive results of the final sample size needed. While patient recruitment continues uninterrupted, the interim analysis will be conducted in the upcoming weeks and is expected to be completed by late January or early February 2010. This analysis may demonstrate that the previously planned trial size is sufficient, or it may indicate a need to expand the size in order to achieve statistical significance of all end points. If an expansion of the trial is determined to be necessary, the timing for advancing the Premarket Notification 510(k) through the FDA will be evaluated and adjusted to ensure that the quality of the trial is not compromised and the clinical and statistical results are sound and compelling.
AppyScore is anticipated to be used as a diagnostic tool to aid emergency department physicians in identifying a subset of patients for whom the risk of acute appendicitis is sufficiently low to support consideration for delaying or eliminating the need for computed tomography (commonly known as a CAT scan) and/or immediate surgical consultation.
To address the 510(k) and related matters, the company has scheduled a meeting with the FDA in January 2010. One of the objectives of the meeting is to ensure alignment with the FDA with respect to the data requirements necessary to support the proposed intended use and clinical utility of the AppyScore test.
Following the meeting with the FDA and the completion of the interim data analysis, the company expects to be in a position to provide a further update to shareholders regarding the supplemental clinical trial patient size and plans for advancing 510(k) clearance.
Clinical trials of the rapid assay are planned for 2010 and will be designed to support a 510(k) submission for this rapid assay platform using the ELISA test as a predicate, assuming the ELISA test is cleared by the FDA. In addition, these trials will provide AspenBio and physicians with additional information on the product's potential utility. The company expects to announce the execution of supply agreements with internationally recognized manufacturers for the rapid assay device and reader instrument as they are finalized.
The previously announced AppyScore supplemental clinical trial continues to advance, with over 400 patients enrolled to-date from the emergency departments of more than a dozen well-known hospitals across the United States. Based upon additional analysis of prior trial data, as well as input from a panel of clinical experts assembled by AspenBio's regulatory consultants, the Statistical Analysis Plan ("SAP") for this supplemental trial has now been finalized. This SAP defines a study end point for the AppyScore test alone, and additionally, adds two alternative end points which evaluate the AppyScore result in combination with either white blood cell count ("WBC") or neutrophil count.
Applying the parameters of this SAP in a retrospective analysis of the previous pivotal clinical trial data improved the negative predictive value ("NPV") of AppyScore to more than 95% in the subset of patients who have negative results for either the combination of AppyScore/WBC or AppyScore/neutrophil count. While there can be no absolute assurance that these results will be repeated in the current supplemental clinical trial, the company believes such results, if repeated would substantially enhance the clinical utility and value of AppyScore in the emergency department setting.
The SAP provides for, and AspenBio has scheduled, an interim analysis of the clinical trial data to validate the required supplemental trial sample size necessary to achieve statistical significance for all study endpoints. Achieving statistical significance is essential for the inclusion of these important study end points in the submission of the Premarket Notification 510(k) information to the FDA, as well as describing clinical utility to physicians. This interim analysis was initially planned to be conducted with data from 250 patients; however, with the addition of the two new alternative study end points, a 400 patient interim data analysis will provide better predictive results of the final sample size needed. While patient recruitment continues uninterrupted, the interim analysis will be conducted in the upcoming weeks and is expected to be completed by late January or early February 2010. This analysis may demonstrate that the previously planned trial size is sufficient, or it may indicate a need to expand the size in order to achieve statistical significance of all end points. If an expansion of the trial is determined to be necessary, the timing for advancing the Premarket Notification 510(k) through the FDA will be evaluated and adjusted to ensure that the quality of the trial is not compromised and the clinical and statistical results are sound and compelling.
AppyScore is anticipated to be used as a diagnostic tool to aid emergency department physicians in identifying a subset of patients for whom the risk of acute appendicitis is sufficiently low to support consideration for delaying or eliminating the need for computed tomography (commonly known as a CAT scan) and/or immediate surgical consultation.
To address the 510(k) and related matters, the company has scheduled a meeting with the FDA in January 2010. One of the objectives of the meeting is to ensure alignment with the FDA with respect to the data requirements necessary to support the proposed intended use and clinical utility of the AppyScore test.
Following the meeting with the FDA and the completion of the interim data analysis, the company expects to be in a position to provide a further update to shareholders regarding the supplemental clinical trial patient size and plans for advancing 510(k) clearance.
Clinical trials of the rapid assay are planned for 2010 and will be designed to support a 510(k) submission for this rapid assay platform using the ELISA test as a predicate, assuming the ELISA test is cleared by the FDA. In addition, these trials will provide AspenBio and physicians with additional information on the product's potential utility. The company expects to announce the execution of supply agreements with internationally recognized manufacturers for the rapid assay device and reader instrument as they are finalized.
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