AspenBio Pharma (APPY) Updates on AppyScore Pilot Study
Tweet
Share
E-mailGet Alerts APPY Hot Sheet
Join SI Premium – FREE
AspenBio Pharma, Inc. (Nasdaq: APPY), reported on its recently completed pilot study, multi-marker product profile and product pathway for AppyScore", a test designed to help physicians rule out acute appendicitis in pediatric and adolescent patients entering emergency rooms with symptoms suspicious for acute appendicitis.
From the release: "Analysis of Pilot Study Data Using Multi-Marker Panel AspenBio's pilot study involved pediatric and adolescent patients aged 2 to 20 with symptoms suspicious for acute appendicitis who were enrolled from 11 hospital sites across the country. Data analysis was completed on 431 study subjects, exhibiting a prevalence of acute appendicitis in the population of 27%. The clinical significance of the data from this study will serve as the basis for the company to proceed with the AppyScore product optimization in a multi-marker configuration and proceed with its plans for a pivotal trial.
The pilot study evaluated the use of multiple markers for the AppyScore test configuration and demonstrated appreciably better results than the single-marker test evaluated in previous studies. The panel for AppyScore will comprise two biomarkers -- the company's patented MRP 8/14 biomarker and C-Reactive Protein ("CRP"), along with White Blood Cell Count ("WBC"). The concentration in blood or plasma of each of these components was measured and the results analyzed using an algorithm. The algorithm uses both advanced proprietary and commercial software programs that optimize the interactions and outcomes to produce a single test result as the AppyScore.
This sample set from the 2008 clinical study represented a subset of patients from the total study and the subset had a 30% prevalence of acute appendicitis. The confidence intervals for the 2008 data set were wider than the results of the 2011 pilot study, which is believed to be due to the smaller number of patients (188) in this study subset versus 431 in the 2011 study. Notwithstanding these differences in the 2008 clinical trial patient population, the company believes the results of this additional patient population verify the results of our 2011 pilot study.
If AppyScore achieves regulatory clearance by the U.S. Food and Drug Administration, the company anticipates the product's intended use will be as a test to rule out acute appendicitis in pediatric and adolescent patients entering emergency rooms having signs and symptoms consistent with, or suspicious for, the disease."
From the release: "Analysis of Pilot Study Data Using Multi-Marker Panel AspenBio's pilot study involved pediatric and adolescent patients aged 2 to 20 with symptoms suspicious for acute appendicitis who were enrolled from 11 hospital sites across the country. Data analysis was completed on 431 study subjects, exhibiting a prevalence of acute appendicitis in the population of 27%. The clinical significance of the data from this study will serve as the basis for the company to proceed with the AppyScore product optimization in a multi-marker configuration and proceed with its plans for a pivotal trial.
The pilot study evaluated the use of multiple markers for the AppyScore test configuration and demonstrated appreciably better results than the single-marker test evaluated in previous studies. The panel for AppyScore will comprise two biomarkers -- the company's patented MRP 8/14 biomarker and C-Reactive Protein ("CRP"), along with White Blood Cell Count ("WBC"). The concentration in blood or plasma of each of these components was measured and the results analyzed using an algorithm. The algorithm uses both advanced proprietary and commercial software programs that optimize the interactions and outcomes to produce a single test result as the AppyScore.
This sample set from the 2008 clinical study represented a subset of patients from the total study and the subset had a 30% prevalence of acute appendicitis. The confidence intervals for the 2008 data set were wider than the results of the 2011 pilot study, which is believed to be due to the smaller number of patients (188) in this study subset versus 431 in the 2011 study. Notwithstanding these differences in the 2008 clinical trial patient population, the company believes the results of this additional patient population verify the results of our 2011 pilot study.
If AppyScore achieves regulatory clearance by the U.S. Food and Drug Administration, the company anticipates the product's intended use will be as a test to rule out acute appendicitis in pediatric and adolescent patients entering emergency rooms having signs and symptoms consistent with, or suspicious for, the disease."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
- Cytek faces $56M damages award in Beckman Coulter patent case
- Sigma Lithium resumes full operations after signing TAC agreement
Create E-mail Alert Related Categories
Corporate News, FDASign 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!
