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First Patient Enrolled in RAPID MI-ICE Study Employing InnerCool’s Endovascular Temperature Modulation Therapy for Heart Attack |
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The RAPID MI-ICE (Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention) study is expected to enroll approximately 20 patients who present within six hours of their heart attack and require angioplasty and stent procedures in order to restore blood flow to the heart. Eligible patients will be randomized to one of two treatment protocols, and the effects on heart tissue damage will be compared. Patients randomized to the cooling arm (hypothermia) will receive an iced saline infusion in addition to the use of the InnerCool Accutrol™ endovascular catheter, which contains an integrated temperature sensor that accurately measures the patient’s core body temperature. Patients assigned to the normothermia arm will receive routine standard of care without induced hypothermia. The trial will employ cardiac magnetic resonance imaging (MRI) to provide an assessment of the damage to the heart, as measured by infarct size, within days of the heart attack. Additional details of the study can be found at www.clinicaltrials.gov. Researchers from the Interventional Cardiology Center at Lund University Hospital recently presented their pre-clinical results at the Transcatheter Cardiovascular Therapeutics (TCT) 2006 Annual Meeting in Washington, D.C. In a porcine heart attack model, the investigators evaluated rapid cooling, induced by a combination of cold saline infusion along with InnerCool’s catheter-based system, prior to or coincident with angioplasty and stent procedures. The data showed that cooling prior to reperfusion reduced overall infarct size (a measure of tissue damage) by 40% compared to the control group. In addition, a meta-analysis that included data from the Intravascular Cooling Adjunctive to Percutaneous Coronary Intervention (ICE-IT) study, a 228-patient study, suggested that a 20% to 40% reduction of infarct size is possible when patients are cooled early and rapidly with an endovascular temperature modulation system as an adjunct to angioplasty and stent procedures. “Preclinical and preliminary clinical data suggest that endovascular temperature modulation therapy may have the potential to enable interventional cardiologists to dramatically reduce heart tissue damage following a heart attack,” stated David Erlinge, M.D., Ph.D. of the Lund University Cardiology Center. “We are pleased to be working with cardiologists from the world-renowned Lund University Hospital to explore a potential new application for InnerCool’s endovascular temperature modulation therapy,” stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies. “We believe the InnerCool Accutrol endovascular catheter is best-in-class. It has the power to provide for rapid cooling and, with the unique integrated temperature sensor, it accurately measures the patient’s core body temperature. This integrated combination of features is essential to handle the performance requirements of the RAPID MI-ICE study. Our progressive temperature modulation approach represents an important therapeutic paradigm for InnerCool moving forward, and we are excited about the upcoming launch of InnerCool’s new external temperature modulation system, which will provide a complementary tool for use in less-acute patients.” Temperature Modulation Therapy for Ischemic Injury About InnerCool Last month InnerCool announced plans to launch two next-generation medical device systems designed to provide innovative and comprehensive solutions for patient temperature modulation. InnerCool’s new internal temperature modulation system, which will include an enhanced console and disposable catheter, is designed to also enable rapid re-warming of patients following surgery or other medical procedures, and for the potential warming of trauma and other appropriate patients. InnerCool’s new external temperature modulation system, which will include a console and disposable pads, will provide a complementary tool for use in less-acute patients and in clinical settings that do not require very rapid cooling or re-warming, or which are best suited to prolonged temperature management. About Cardium In March 2006, Cardium acquired the technologies and products of InnerCool Therapies, Inc., a San Diego-based medical technology company in the emerging field of temperature modulation, which is designed to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes. For more information about Cardium's InnerCool subsidiary and therapeutic hypothermia, including its Celsius Control System™, which has received regulatory clearance in the U.S., Europe and Australia, please visit www.innercool.com. In August 2006, Cardium acquired the technologies and products of the Tissue Repair Company (TRC), a San Diego-based biopharmaceutical company focused on the development of growth factor therapeutics for the treatment of severe chronic diabetic wounds. TRC’s lead product candidate, Excellarate, is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-B (PDGF-B). Excellarate is initially being developed to be administered once or twice for the potential treatment of non-healing diabetic foot ulcers. Other potential applications for TRC’s Gene Activated Matrix™ (GAM) technology include therapeutic angiogenesis (cardiovascular ischemia, peripheral arterial disease) and orthopedic products, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage) repair. For more information about Cardium’s Tissue Repair Company subsidiary, please visit www.t-r-co.com. Forward-Looking Statements Copyright 2007 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit www.cardiumthx.com.Cardium Therapeutics™ and Generx™ are
trademarks of Cardium Therapeutics, Inc. SOURCE: Cardium Therapeutics, Inc. |
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