AspenBio Pharma Inc reported conclusions from its pre-planned, independent, interim analysis of the company’s ongoing supplemental clinical trial of AppyScore™, the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis, and outlined next steps for its AppyScore 510(k) filing with the FDA.
Based on the interim analysis, the trial, currently with over 600 patients enrolled, will continue enrollment to approximately 800 patients with completion anticipated in March of 2010. Given the time estimate to complete the current trial and related data analysis, the Company has withdrawn its 510(k) on file with the FDA and will submit a new 510(k) with full results from the ongoing clinical trial. This clinical trial is statistically sized to stand alone and thereby becomes the pivotal trial to support the new 510(k) submission.
"We believe AppyScore has the potential to help improve physicians’ evaluation of appendicitis, eliminating unnecessary CT scans and reducing radiation exposure risk for patients — while also reducing health care costs," said Daryl J. Faulkner, Chief Executive Officer of AspenBio Pharma. "We continue to actively enroll patients in the ongoing clinical trial and believe that submitting a new 510(k) based on a full analysis of the data from this study will provide the most effective path to 510(k) clearance. Our new timeline includes finalizing the trial results and submitting the new 510(k) in the second quarter of 2010.
"In addition, we continue to make excellent progress advancing our second generation AppyScore product — a stand-alone, state-of-the-art cassette and reader instrument platform — and anticipate being in a position to begin clinical trials for this rapid assay in the second half of 2010," concluded Faulkner.
Interim statistical analyses are conducted to advise clinical trial sponsors on the progress of a study to determine if: 1) a trial should be stopped as the defined end point(s) will not be reached; 2) a trial should be stopped as the end point(s) have already been reached; or 3) a trial should continue as planned. A fourth item was included in AspenBio’s interim analysis to determine if the clinical trial size should be expanded in order to generate the statistical power needed to reach defined end point(s).
The interim analysis report for AspenBio’s trial concluded that the trial should continue. Based upon the data set, the interim analysis determined that the trial is adequately sized for the primary endpoint goal, the use of AppyScore test alone. However, the data set gathered for the interim analysis was not sufficient to provide guidance, at this stage, on if the trial is adequately sized for the secondary endpoints — using AppyScore in combination with either white blood cell count (WBC) or neutrophil count. The Company and all participants in the study remain blinded to the data until the close of the study and there can be no assurance of the outcome of the study based on the interim analysis.
Source: Aspen BioPharma
