Luoxis Diagnostics, Inc. announces positive results from first clinical study conducted with company's proprietary diagnostic platform

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Jun 20, 2013, 08:00 ET

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.

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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.

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 Pharmaceuticals, Inc.

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.

Investor Contact:
Rick Giles
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
Email: [email protected]

SOURCE Ampio Pharmaceuticals, Inc.