Luoxis Announces Presentation of Multiple Studies Validating RedoxSYS as a Rapid and Non-invasive Means of Assessing Oxidative Stress

ENGLEWOOD, Colo., Nov. 24, 2014 /PRNewswire/ -- Luoxis Diagnostics, Inc., a subsidiary of Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE), today announced the presentation of three clinical and preclinical studies showcasing its RedoxSYS™ Diagnostic System as a broadly applicable and robust research tool capable of measuring oxidation-reduction potential (ORP) in the body in response to injury, illness, or stress.  In all three studies, which were performed in collaboration with Luoxis' academic and pharmaceutical research partners, RedoxSYS was able to assess biologically relevant changes in ORP, allowing it to serve as a simple, rapid biomarker of global oxidative stress.

The studies were presented as a series of peer-reviewed posters at the 21^st annual meeting of The Society for Free Radical Biology and Medicine (SFBRM), held November 19-23, 2014, in Seattle, Washington.  More than 500 oxidative stress researchers from around the world attended the meeting.  Two of the studies utilized RedoxSYS to evaluate the impact of development-stage antioxidant therapies on reducing oxidative stress in neurodegenerative diseases using mouse models of Parkinson's disease and multiple sclerosis.  A third study showed that RedoxSYS enabled rapid and non-invasive assessment of exercise-induced oxidative stress in athletes, compared to conventional oxidative stress markers.

Josh Disbrow, Luoxis' President and Chief Executive Officer, stated, "These research studies serve as important foundational evidence for the versatile applicability and broad potential of our novel RedoxSYS platform.  We are grateful to our partners for helping us to validate our first-in-class product, which may not only have potential as an acute care clinical diagnostic system, but also as a valuable research tool that could facilitate and possibly accelerate the development of future therapies for a wide range of diseases.  We are continuing to pursue global research collaborations as part of our ongoing market development strategy, and we look forward to sharing additional updates on our progress."

In a mouse model of Parkinson's disease¹, RedoxSYS effectively measured static ORP (sORP), a "snapshot" of current redox balance, in serum samples to determine the degree of reduction in oxidative stress following treatment with development-stage antioxidant candidates.  In this study, sORP proved to be a reliable biomarker of oxidative stress, which is known to contribute to the deterioration of dopaminergic cells and leads to development of Parkinson's disease. The researchers of the study concluded that monitoring oxidative stress with ORP among patients with Parkinson's disease might be beneficial in assessing severity of the disease and effectiveness of therapeutic interventions.

RedoxSYS was also used to help characterize various investigational custom-synthesized antioxidant nanoparticles in a mouse model of multiple sclerosis² by assessing changes in ORP in the brain tissue of treated mice.  In addition to being an efficient means of measuring oxidative stress, RedoxSYS was sensitive enough to enable detection of small differences in ORP based on the specific physiochemical parameters of the nanoparticles.

Requiring only a single droplet of blood plasma, RedoxSYS was used to assess two global parameters of oxidative stress, sORP and capacity ORP (cORP), in comparison to six commonly used, individual markers of oxidative stress, in athletes participating in a mountain marathon race³.  The study concluded that RedoxSYS can be used for evaluating exercised-induced oxidative stress, and the efficiency of a rapid, non-invasive and global assessment of ORP may represent an advantage over current, more cumbersome markers.

Poster Detail:

• Poster Title: Assessment of Oxidative Stress and Treatment with an Investigational Antioxidant Compound in a Mouse Model of Parkinson's Disease
  Author(s): Lisa M. Caputo, MA; Chad E. Beyer, PhD, MBA; Michael P. Neary, BS; Michael J. Zigmond, PhD; Sandra L. Castro; David Bar-Or, MD; Swedish Medical Center, Englewood, CO; Saint Anthony's Hospital, Lakewood, CO; University of Pittsburgh, Pittsburgh, PA
• Poster Title: Assessment of catalytic activity and oxidation-reduction potential of custom-synthesized cerium oxide nanoparticles in cell-free systems and tissue.
  Author(s): Ana Y. Estevez, Sierra Miller, Quinn R. Self, Joseph S. Erlichman; Saint Lawrence University, Canton, NY
• Poster Title: A new method for assessing redox status: Application in strenuous exercise-induced oxidative stress
  Author(s): Dimitrios Stagos; Nikolaos Goutzourelas; David Bar-Or, MD; Dimitrios Kouretas; University of Thessaly, Larissa, Greece; Swedish Medical Center, Englewood, CO; Saint Anthony's Hospital, Lakewood, CO

About the RedoxSYS Diagnostic System:
The RedoxSYS Diagnostic System is a first-in-class clinical diagnostic platform that measures oxidation-reduction potential (ORP) in the body, a homeostatic measurement of oxidative stress that changes in response to injury or illness. The result of nearly two decades of clinical, scientific and technical R&D, the RedoxSYS System is able to provide the only complete assessment of a patient's oxidative status, which has broad diagnostic application across multiple disease areas where oxidative stress is implicated. Luoxis is currently developing RedoxSYS as a simple, rapid blood test for use in the critical care setting, where its ability to provide an objective measurement of patient illness and predict potential complications may enable physicians to improve resource allocation and align higher levels of care with the most critically injured and ill patients, leading to improved outcomes and optimal workflows.

About Luoxis Diagnostics:
Luoxis Diagnostics is an in vitro diagnostics company focused on developing and commercializing its proprietary, CE Marked RedoxSYS Diagnostic System. The company is currently developing RedoxSYS to address the $4+ billion critical care market, where it has the potential to provide hospitals with a single, rapid solution with unmatched diagnostic/prognostic value for conditions with significant medical need, and for which few diagnostic biomarkers exist. Luoxis is conducting initial market development for RedoxSYS in select European territories in order to validate and quantify the clinical value of RedoxSYS for monitoring injury severity and patient oxidative stress following traumatic brain injury, multi-trauma injury, and other critical illnesses. Luoxis is also pursuing U.S. regulatory clearance for RedoxSYS, based on completed and ongoing clinical studies in multiple critical care conditions in the United States, including TBI, multi-trauma injury, stroke, sepsis, and other life-threatening conditions. Luoxis has research collaborations in place with leading centers around the world. Luoxis is a majority-owned subsidiary of Ampio Pharmaceuticals, Inc. For more information, visit www.luoxis.com.

About Ampio Pharmaceuticals:
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.

RedoxSYS and Luoxis are trademarks of Luoxis Diagnostics, Inc.

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.

For Investors & Media:
Tiberend Strategic Advisors, Inc.

Joshua Drumm, Ph.D.: [email protected]; (212) 375-2664

Amy Wheeler: [email protected]; (646) 362-5750

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SOURCE Ampio Pharmaceuticals, Inc.

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