Ampio Pharmaceuticals
AMPE today announced that majority-owned subsidiary Luoxis
Diagnostics announced positive summary data from the first clinical trial
using the company's oxidation-reduction potential (ORP) diagnostic system. The
ORP system is a novel, patented point-of-care diagnostic platform measuring
markers of oxidative stress and antioxidant reserves. These study results are
the first to be reported among multiple clinical trials that have been
conducted across numerous critical illnesses.
The results are reported from a prospective clinical trial of 153 elderly hip
fracture patients who suffered their hip fractures as a result of a fall, the
most common cause of hip fractures among the elderly. When studying the
markers measured by the ORP diagnostic system, investigators demonstrated
statistically significant correlations between patients' antioxidant reserve
levels and established comorbidity measures (p=0.02). Investigators also
reported a statistically significant correlation between patients'
oxidation-reduction potential levels and injury severity as measured by the
validated Injury Severity Score (ISS; p=0.01). These clinical study results
confirm the predictive value of oxidation-reduction potential and antioxidant
reserves and their validity as prognostic markers among elderly hip fracture
patients in a clinical setting. Detailed results from this clinical trial will
be published later this year.
Knowing the antioxidant reserves (referred to as Capacity) and ORP status of
the patient is important for clinical management of the patient in the
hospital or for discharge disposition (home, nursing home, skilled nursing
facility, etc.) and adds an objective metric for resuscitation efforts on a
real-time basis from a single drop of blood. A low capacity appears to
indicate patient frailty and accordingly calls for caution in the performance
of timely surgery, monitoring of anesthesia and complications and more. Hip
fracture in patients over 65 years of age is associated with 2-3% in hospital
mortality and grows to approximately 20-30% in the following six months. We
hope that the ORP diagnostic platform will improve these statistics by
shedding light on the causes of this high mortality rate, thus offering some
therapeutics and assist the clinician in monitoring the health status of these
patients.
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