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SOURCE Ampio Pharmaceuticals, Inc.; Luoxis Diagnostics
With CE mark in place and FDA-directed studies underway in US, company accelerates market development efforts in US, Canada, Israel, and multiple countries in Europe
ENGLEWOOD, Colo., Aug. 11, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that subsidiary Luoxis Diagnostics has expanded its academic and pharmaceutical research network to over 25 sites around the world. To date the company has initiated over 17 scientific and clinical research studies, and Luoxis expects to initiate over 30 additional studies globally by the end of the year.
Since obtaining CE marking for the RedoxSYS system in early 2014, Luoxis has built a global network of research sites focused on further establishing the clinical utility of ORP across a range of critical illnesses. The company has engaged over 12 academic research centers across North America and 13 sites in Europe including prominent centers in Belgium, England, France, Germany, Greece, and Wales.
The company has also initiated research collaborations with five pharmaceutical companies in both the US and Europe, through which these companies are utilizing the RedoxSYS platform to perform drug development research on therapeutic candidates known to affect oxidative stress pathways. These studies span a broad range of therapeutic candidates in numerous disease areas.
Josh Disbrow, Luoxis' President and Chief Executive Officer explained, "This rapid expansion of the company's network of both academic and pharmaceutical researchers around the world speaks to the pervasive role of oxidative stress in disease and the broad clinical application of ORP in both important sectors of research. Through these research agreements, we have been able to rapidly place the RedoxSYS Diagnostic System at leading centers around the world, and these studies are already generating robust clinical utility data for ORP – with minimal cost to the company. We are pleased with the research community's response to ORP as a novel, global marker of oxidative stress, and we continue to execute rapidly on one of the company's objectives of establishing clinical validation and utility data for oxidation-reduction potential in these real-world research settings. Further, with numerous relationships now in place with pharmaceutical companies, we continue to expand our network of prominent pharma researchers now integrating ORP into various stages of drug development."
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.
Luoxis 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.
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