Luoxis Diagnostics, Inc. announces positive results from first clinical study
conducted with company's proprietary diagnostic platform
GREENWOOD VILLAGE, Colo., June 20, 2013
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
Luoxis Chief Scientific Officer David Bar-Or, MD commented, "we are pleased
with the results of this clinical trial as it clearly demonstrates how
oxidation-reduction potential measurements provide meaningful diagnostic
insights into the health of elderly hip fracture patients.By uncovering a
patient's oxidation-reduction potential and antioxidant reserve levels with a
simple point-of-care blood test, clinicians may more effectively stratify and
treat hip fracture patients according to the seriousness of their
condition.This may ultimately enable more aggressive clinical intervention as
we believe these oxidation-reduction potential measurements are true
biomarkers of patient frailty."
The results from this study and the other completed studies will support
Luoxis' planned regulatory submissions in the US, Canada, Europe, and other
large markets to enable regulatory clearance around the world.
About Luoxis Diagnostics
Luoxis Diagnostics, Inc. is an in-vitro diagnostics company focused on the
development and global commercialization of a point-of-care hand held device
and disposable sensors that measures, from a single drop of blood, the
presence of oxidative stress and antioxidant reserves in a patient.
Oxidation-reduction potential is an important measure in the detection of both
critical and chronic illnesses and is a novel marker of patient morbidity
across a wide range of diseases and conditions. There are numerous clinical
indications for this homeostatic parameter for which there is no currently
available point-of-care test.Luoxis is a majority-owned subsidiary of Ampio
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company
focused on the rapid development of therapies to treat prevalent inflammatory
conditions for which there are limited treatment options. We are developing
compounds that decrease inflammation by (i) inhibition of specific
pro-inflammatory compounds by affecting specific pathways at the protein
expression and at the transcription level (ii) activation of a specific
phosphatase or depletion of the available phosphate needed for the
inflammation process and (iii) decreasing vascular permeability – an upstream
event in the inflammation cascade.
About the ORP Diagnostic System
The ORP diagnostic system is a patented point-of-care diagnostic instrument
with accompanying disposable sensors that rapidly measures and reports unique
oxidative stress parameters by analyzing a single drop of a blood or plasma.
Prior to the development of the Luoxis ORP diagnostic system, oxidative stress
measurement was incomplete, time consuming and impractical in a clinical
setting. The ORP diagnostic system has clinical application across numerous
critical and chronic illnesses. Multiple clinical trials have been completed
using the patented ORP diagnostic system that have demonstrated the predictive
value of the biomarkers uniquely measured by the ORP system.
Forward Looking Statement
Ampio's statements in this press release that are not historical fact and that
relate to future plans or events are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by use of words such as
"believe," "expect," "plan," "anticipate," and similar expressions. These
forward-looking statements include risks associated with clinical trials,
expected results, regulatory approvals, and changes in business conditions and
similar events. The risks and uncertainties involved include those detailed
from time to time in Ampio's filings with the Securities and Exchange
Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports
on Form 10-Q.
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
SOURCE Ampio Pharmaceuticals, Inc.
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