AspenBio (APPY) Reports BioMarker Use Improves MRP 8/14 Results
Tweet Send to a Friend
Up)
AspenBio Pharma, Inc. (Nasdaq: APPY), reported on its progress with AppyScore", a test designed to aid in managing the large numbers of patients who enter emergency rooms every year complaining of abdominal pain suspicious for appendicitis. AppyScore would aid in helping to rule out appendicitis in those patients who are at low to moderate risk.
Regulatory Interactions During the third quarter, the company received feedback from representatives of the FDA review team regarding AppyScore's intended use, its clinical and regulatory pathway, and the company's plans for a pivotal clinical trial.
In discussions with the FDA, the agency was amenable to a product profile that uses a risk stratification model to identify low-to-moderate risk patients, followed by a diagnostic test to help confirm the patients who are at low-to-moderate risk so they can be managed accordingly. D-dimer, a widely-used diagnostic blood-based test designed to help rule out pulmonary embolism, is an example of a risk stratification model and diagnostic test that has been cleared for use. The FDA also indicated that the factors used to assess a risk stratification model would need to be validated as part of the planned AppyScore clinical trial.
Interim Analysis of Pre-Clinical Study AspenBio's pilot study currently involves 11 hospital sites across the country that are enrolling patients towards an estimated 500 total patients the company plans to include in the study. Approximately 400 patients have been enrolled to-date, with patient information, samples and data analysis completed on 197 of these study subjects. The pilot study is ongoing, and further patient recruitment is required for the data results to achieve statistical significance.
The interim analysis using the company's patented MRP 8/14 biomarker provided outcomes that were generally consistent with MRP 8/14 results noted in prior trials. The interim analysis also included evaluation of certain additional biomarkers (identified during AspenBio's discovery work which commenced early this year) that may have better or unique performance characteristics as compared to MRP 8/14 alone. The use of multiple biomarkers as the diagnostic test format also provided improved outcomes.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
Regulatory Interactions During the third quarter, the company received feedback from representatives of the FDA review team regarding AppyScore's intended use, its clinical and regulatory pathway, and the company's plans for a pivotal clinical trial.
In discussions with the FDA, the agency was amenable to a product profile that uses a risk stratification model to identify low-to-moderate risk patients, followed by a diagnostic test to help confirm the patients who are at low-to-moderate risk so they can be managed accordingly. D-dimer, a widely-used diagnostic blood-based test designed to help rule out pulmonary embolism, is an example of a risk stratification model and diagnostic test that has been cleared for use. The FDA also indicated that the factors used to assess a risk stratification model would need to be validated as part of the planned AppyScore clinical trial.
Interim Analysis of Pre-Clinical Study AspenBio's pilot study currently involves 11 hospital sites across the country that are enrolling patients towards an estimated 500 total patients the company plans to include in the study. Approximately 400 patients have been enrolled to-date, with patient information, samples and data analysis completed on 197 of these study subjects. The pilot study is ongoing, and further patient recruitment is required for the data results to achieve statistical significance.
The interim analysis using the company's patented MRP 8/14 biomarker provided outcomes that were generally consistent with MRP 8/14 results noted in prior trials. The interim analysis also included evaluation of certain additional biomarkers (identified during AspenBio's discovery work which commenced early this year) that may have better or unique performance characteristics as compared to MRP 8/14 alone. The use of multiple biomarkers as the diagnostic test format also provided improved outcomes.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Cytokinetics (CYTK) ATOMIC-AHF Results to Be Presented at ESC Congress 2013 (AMGN)
- New Mountain Finance (NMFC) Prices Aggregate 6M Common Offering
- Genetic Tech (GENE) Updates on Impact of SCOTUS Ruling on Gene Patenting
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
