Ampio Pharmaceuticals Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities (NMEs), has completed patient enrollment for its multiple indication diagnostic clinical trials.

The clinical trials include patients presenting to the emergency dept. with chest pain and undergoing clinical evaluation including the performance of Positron Emission Tomography coupled to Computerized Axial Tomography (PET/CT) to detect the presence or absence of myocardial ischemia (523 patients enrolled), patients presenting with stroke symptoms (850 patients enrolled) and in trauma patients including traumatic brain injury where we already published favourable results (more than 3500 patients enrolled). The analysis of the results of these trials will determine the clinical utility of this technology and the company will begin preparing a 510(k) submission upon completion of data analysis, expected in the near future.

Michael Macaluso, Ampio's CEO, noted that subsets of these patients will be analyzed for the use of ORP in hospital readmission prediction / prevention / reduction. Recent publications of two editorials in the New England Journal of Medicine (N Engl J Med. 2012 Mar 28, N Engl J Med. 2012 Mar 28) outline the difficulties and financial penalties imposed upon hospitals that readmit Medicare and Medicaid patients within 30 days of discharge. “Beneficiaries are rehospitalized within 30 days after discharge at an annual cost of $17 billion” (NEJM 2009, 360:1418-28). The lack of a metric to determine preventable and non-preventable readmission is problematic and Ampio hopes that ORP measurements at or close to discharge may reduce readmission associated costs both to hospitals and insurers.”

ORP is a homoeostatic parameter that reflects the net balance between pro and anti-oxidants in a biological sample. In health there is an abundance of antioxidants over oxidants so that the balance is in favour of anti-oxidants. In sickness, when free radicals and others oxidative species are formed, the anti-oxidants are consumed and the balance shifts in favor of oxidants that further damage important structures such as proteins, lipids and other cellular and extracellular components. Because of the large number of known pro-oxidants and antioxidants in blood, it is not feasible in the clinical setting to measure each one component in order to calculate the net ORP balance.

The platform technology developed at Ampio allows for the rapid bed-side measurement of ORP (in seconds) utilizing a point of care, portable, battery operated and compact instrument (analogous to a glucometer) and disposable electrodes (analogous to the glucose strips) from a single drop of blood. The instrument, the electrode and numerous methods of use are protected by multiple patent filings.

Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction.