Case ID:
2007-0406
Web Published:
10/6/2011
Overview:
Currently,
there exists no method for stratifying pediatric septic shock clinical trial
candidates. Specifically, there is no way to eliminate patients that would have
a high likelihood of a positive outcome with standard care from these trials.
Dr. Wong at Cincinnati Children's Hospital has demonstrated that there is a
marked increase in a specific protein in the serum of a non-survivor cohort of
septic shock patients. Studies have also established a threshold value for serum
levels of this protein, such that patients below this value will likely have a
good outcome with respect to septic shock (95% certainty).
The
strategy would involve exclusion of patients that would otherwise qualify for
trails, except that they have an admission marker serum level below the
threshold value. This would improve the risk-to-benefit ratio of the study
compound by prospectively eliminating patients that would otherwise have a high
likelihood of doing well with stand care.
Recently,
Dr. Wong received additional validation of the marker after examining a cohort
of patient samples collected by an outside group. The samples from this cohort
had their marker serum levels measured using a different method than patients at
Cincinnati Children's. The results, however, were remarkably similar to those
identified previously. A predictive value for a positive outcome was determined
to be 94%.
Applications:
·
Stratification
of septic shock clinical trials for pediatric, and potentially adult patients
Advantages:
·
Excludes
patients that would do well without trial compound
·
Improves
risk-to-benefit ratio of clinical trials
·
Easy
to measure
·
Eliminates
unnecessary exposure to trial medications
Patent
Information:
Patents
Pending
Cincinnati
Children's Lead Inventor:
Hector
Wong, M.D.
Business
Opportunity: Exclusive
Licensee & Research Collaborations
tage
of Development:
Clinical Trials Needed
Brief
Description:
Use of IL-8 Serum Biomarker to Stratify Patients in Septic Shock Clinical Trials
Patent Information:
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