Ampio Pharmaceuticals subsidiary Luoxis Diagnostics announces positive summary data from study of traumatic brain …

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

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 DiagnosticsLuoxis 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.

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