GREENWOOD VILLAGE, Colo., June 20, 2013 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE MKT: 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.