Ampio Pharmaceuticals subsidiary Luoxis Diagnostics announces positive summary data from study of traumatic brain injury patients and issuance of company's third US patent for its oxidation-reduction potential diagnostic platform

GREENWOOD VILLAGE, Colo., Oct. 1, 2013 /PRNewswire/ -- Luoxis Diagnostics (a subsidiary of Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE), today announced results from a recently completed clinical study of patients with isolated traumatic brain injury (iTBI).  This study demonstrated statistically significant correlations between oxidation-reduction potential (ORP) and the severity of injury among iTBI patients.  ORP is measured using the company's proprietary RedoxSYS™ diagnostic system, a point-of-care diagnostic system enabling rapid analysis of multiple markers of oxidative stress.

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Increases in plasma static oxidation-reduction potential (spot measurement, sORP) levels were consistently shown to closely correlate with increases in iTBI severity as measured by the Abbreviated Injury Score (p=0.02). This prospective observational cohort study of 645 iTBI patients was conducted at two level-one trauma centers in the US over five years, and the analysis was completed in September of 2013.

This is the second clinical study demonstrating the correlation between injury severity in iTBI and oxidation-reduction potential [Rael LT, Bar-Or R, Mains CW, Slone DS, Levy AS, Bar-Or D. Plasma oxidation-reduction potential and protein oxidation in traumatic brain injury. J Neurotrauma 2009;26:1203-1211]. Importantly, this is the first study to show that negative changes in sORP and cORP (a novel measure of patient antioxidant reserves) were associated with poor patient outcomes, including discharge of patients to skilled nursing facilities (SNF) and in-hospital mortality.  This study demonstrates the clinical utility of ORP measurements in the overall prognostic assessment of iTBI patients to help predict numerous patient outcomes.    

Of the 645 patients included in this study, 69% were <65 years old, 61% were males, and median brain Abbreviated Injury Score (AIS) was 3. There were 11 deaths and 56 patients were discharged to a skilled nursing facility. After adjustment in a multivariate logistic regression model, a 20mV increase in the first ORP measurement (obtained within 48 hours of admission) was associated with a 4-fold odds increase of in-hospital mortality (OR: 4.24, 95%CI: 1.2-15.3) and 1.3-fold odds increase of being discharged to a SNF (OR: 1.28, 95%CI: 1.00-1.63).  Likewise, decrease in antioxidant reserves, as measured by last inverse Capacity (1/cORP) were associated with significant patients outcomes. For example a 1 unit increase in the last inverse cORP was associated with a 5-fold odds increase in hospital mortality (OR: 5.05, 95%CI 1.2-21.3). Detailed results from this study will be presented at an upcoming scientific meeting. 

Luoxis' Chief Scientific Officer David Bar-Or, MD, commented "this recent analysis in traumatic brain injury demonstrates again how oxidation-reduction potential and antioxidant reserves serve as important markers of injury in this significant condition.  By having a novel measure like ORP available for rapid analysis of oxidative stress and antioxidant reserves, we can enable better clinical insights into these traumatic brain injury patients and potentially improve clinical management based on their condition's severity and ORP measures."

Traumatic brain injury affects at least 1.7 million patients in the US alone each year, and the incidence is highest among patients 75 years of age and older.  Luoxis Diagnostics is studying specific conditions where oxidative stress is implicated, and the company has a distinct focus on critical illness, injury, and frailty among the elderly population.  Additional studies are ongoing to assess oxidation-reduction potential in multiple conditions, and the RedoxSYS diagnostic system is in the final stage of development for regulatory submissions in the US and elsewhere.  As part of the company's regulatory submission preparation, Luoxis has initiated ISO 13485:2003 certification to enable market access in the United States, European Union, Canada, Australia, and elsewhere.

The company also announced the issuance of its third US patent (US patent number 8,512,548) for the RedoxSYS diagnostic system.  This patent covers a broad range of clinical applications of the oxidation-reduction potential platform to augment the company's previously issued patents for both the RedoxSYS reader and disposable ORP sensors.  The company expects the issuance of many additional patents in the US, Europe, Canada, Japan, and other major markets throughout the world. 

Josh Disbrow, Luoxis' Chief Executive Officer explained, "the company has made significant progress in its clinical and technical development as evidenced by these recent clinical results and the issuance of this latest US patent.  To augment this progress, the company is also progressing toward regulatory clearance in the US and elsewhere to enable broad commercialization of the RedoxSYS system.  We believe the oxidation-reduction potential platform will fill an important, unmet need in the diagnosis of critical illness and injuries like traumatic brain injury and look forward to announcing future clinical trial results in the coming months."

About Luoxis Diagnostics
Luoxis Diagnostics, Inc. is an in-vitro diagnostics company focused on the development and global commercialization of a point-of-care diagnostic device and disposable sensors that measure 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 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 RedoxSYS Diagnostic System
The RedoxSYS 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 RedoxSYS diagnostic system, oxidative stress measurement was incomplete, time consuming and impractical in a clinical setting. The RedoxSYS diagnostic system has clinical application across numerous critical and chronic illnesses. Multiple clinical trials have been completed using the patented RedoxSYS diagnostic system that have demonstrated the predictive value of the oxidative stress biomarkers uniquely measured by the RedoxSYS 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 Luoxis Diagnostics; Ampio Pharmaceuticals, Inc.