CellAegis Devices Announces Second Clinical Program to Use the Company's Noninvasive autoRIC™ Device for Chronic Remote Ischemic Conditioning (CRIC) following Acute Myocardial Infarction (AMI)
-- Phase II, randomized, placebo-controlled study at Glenfield Hospital, University of Leicester (UK) will measure primary efficacy endpoint of change from baseline in left ventricular ejection fraction (LVEF) post-percutaneous coronary intervention (PCI) --
TORONTO, May 2, 2013 /PRNewswire/ -- CellAegis Devices, Inc., announced today the first clinical trial program in the European Union to evaluate the use of the Company's autoRIC™ Device for Chronic Remote Ischemic Conditioning (CRIC). In the DREAM study (Daily REmote Ischemic Conditioning following Acute Myocardial Infarction), a University of Leicester-sponsored Phase II, randomized, placebo-controlled clinical study, CRIC will be evaluated for its ability to prevent negative remodeling of the heart in patients following an acute myocardial infarction. A quarter of patients suffering a heart attack show symptoms of heart failure at the time of admission, and CRIC has the potential to interrupt this disease process.
Offering a safe and accurate method to automate RIC at the point of care, CellAegis' autoRIC Device is intended to reduce tissue injury from heart procedures or heart attacks in a hospital or ambulance setting or in the home as directed by a healthcare professional. In July 2012, CellAegis announced receipt of CE Mark Certification for the autoRIC Device, and in February 2013, Health Canada granted a Medical Device Class III license for use of the autoRIC Device in the same indications. The autoRIC Device is not cleared or approved by the FDA and therefore is not available for sale or use in the US.
The University of Leicester-sponsored Phase II study is the fourth trial to incorporate CellAegis' autoRIC Device. In February 2013, CellAegis announced that it had received an Investigational Testing Approval (ITA) from Health Canada allowing for the initiation of clinical testing in Canada of the Company's autoRIC Device for CRIC following acute myocardial infarction (AMI). The Canadian Institutes of Health Research (CIHR)-sponsored study is designed to evaluate the ability of the autoRIC Device to reduce adverse left ventricular remodeling following primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). In November 2012, CellAegis announced an investigator-sponsored clinical trial at Princess Margaret Hospital in Toronto to evaluate the ability of the autoRIC Device to reduce acute kidney injury induced by intraoperative renal ischemia during partial nephrectomy. In August 2012, the Company also announced the initiation of an Aarhus University-sponsored clinical trial program in Europe utilizing the autoRIC Device for patients with evolving STEMI; the trial is measuring the potential to reduce major adverse coronary events and hospitalizations.
Rocky Ganske, CEO of CellAegis Devices, said, "Following certification and licensing in the EU and Canada, a key priority for CellAegis has been to support incorporation of the autoRIC Device in multiple clinical trials throughout the global cardiology community. We believe that findings from these studies will augment the growing body of evidence in support of RIC for diverse applications in cardiovascular disease. For chronic use of RIC, we have seen great interest in the potential impact on improved cardiac remodeling, thus the opportunity to improve the lives of millions of heart failure patients. The advantage of the autoRIC Device in delivering CRIC is that researchers now have a means to conduct trials with patients at home using an easy-to-use device over an extended period. We look forward to the progress and future publication of the Leicester study and the other ongoing studies."
"Remote ischemic conditioning is an area of considerable clinical potential, extending beyond the acute phase of ischemia, but any benefits need to be tested in properly conducted clinical trials," commented Nilesh Samani, MD, FRCP, Study Principal Investigator and Director, Leicester NIHR Biomedical Research Unit in Cardiovascular Disease, Glenfield Hospital, University Hospitals of Leicester. "The autoRIC™ Device provides a very convenient way of delivering daily RIC over a 28-day period, and we are very pleased to be partnering with CellAegis to use the device in the DREAM Study."
The British Heart Foundation estimates that in the United Kingdom, diseases of the heart and circulatory system (cardiovascular disease or CVD) are the main cause of death and accounted for almost 180,000 deaths in 2010 – around one in three of all deaths that year, at a cost to the system of £9 Billion. An estimated 800,000 persons in the UK are living with heart failure, and 20-25% of patients who present with a heart attack will also have symptoms of heart failure. All countries are facing the rising cost burden of treating heart disease as the population ages. According to the American Heart Association, the cost of treating heart disease in the United States will triple by 2030, resulting in an additional $545 billion in spending, which means that urgent implementation of effective strategies are needed to prevent and treat heart disease and stroke.
University of Leicester-sponsored Phase II Study Design
The DREAM study is placebo-controlled and will enroll post-MI patients who have been successfully treated with PCI and who have LVEF less than 45%. Ninety (90) patients will be randomized 1:1 (CRIC or SHAM once daily) for 28 days of treatment. CellAegis' autoRIC Device delivers a 40-minute treatment of repeated ischemia/reperfusion through controlled blood occlusion of the arm (200 mm Hg for 5 minutes followed by 5 minutes of deflation, repeated for 4 cycles).
The primary endpoint is the mean change from baseline in left ventricular ejection fraction (LVEF) 4 months post-PCI via cardiac magnetic resonance imaging (cMRI). Secondary endpoints include: final infarct size 4 months post-PCI (assessed by cMRI); mean levels of biomarkers of heart failure and ventricular remodeling at baseline and 4 months post-PCI, and mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 4 months post-PCI.
Remote ischemic conditioning uses sequences of short, controlled periods of blood occlusion (ischemia) in a limb followed by resumed blood flow (reperfusion). By activating innate mechanisms of metabolic protection in the body, RIC has been shown to reduce the larger injury from ischemia reperfusion to heart and other organs, including myocardial infarctions, cardiac surgery, stroke, trauma, and organ transplantation. Based on studies in over 14,000 individuals in more than 85 ongoing and completed clinical trials worldwide, as well as key findings reported at medical conferences and published in leading peer-reviewed publications, data have shown that RIC can reduce heart damage by up to 40-50% in an evolving heart attack, improve left ventricular ejection fraction in left anterior descending coronary artery (LAD) infarction, and reduces damage and late adverse events during elective PCI, as well as decrease incidences of contrast-medium‐induced nephropathy. A preclinical study concluded that although a single early episode of remote per-conditioning decreases infarct size, repeated remote CRIC further reduces adverse LV remodeling and improved survival in a dose-dependent fashion.
CellAegis Devices, Inc., based in Toronto, Canada, is poised for both EU and Health Canada market introductions in parallel with a broad international clinical testing program of the Company's proprietary, automated, noninvasive autoRIC™ Device for Remote Ischemic Conditioning (RIC). Placed around the arm, CellAegis' autoRIC Device allows for the first time, simple, consistent, reliable and cost‐effective automation of RIC at the point of care, including acute care applications in the ambulance, emergency room and other hospital settings, or for treatment in the home as directed by a healthcare professional. The autoRIC Device is highly portable and time-efficient, delivering four cycles of simple-to-administer treatment in less than 40 minutes. The device is compatible with current standard-of-care treatments.
CellAegis has extensive intellectual property protections for its autoRIC Device. In late 2011, CellAegis received ISO 13485 certification which covers the design, development, manufacturing and distribution of medical devices.
For more information on CellAegis, the autoRIC Device, and the clinical research around RIC, please visit www.cellaegisdevices.com.
SOURCE CellAegis Devices, Inc.
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