Vericel to Present Data at the American Heart Association's Scientific Sessions 2016 on the Reduction of Ventricular Arrhythmias with Ixmyelocel-T in the ixCELL-DCM Clinical Trial
CAMBRIDGE, Mass., Sept. 07, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of autologous expanded cellular therapies for the treatment of severe diseases and conditions, today announced the acceptance of an abstract for presentation at the American Heart Association's Scientific Sessions 2016 entitled "Reduction in Ventricular Arrhythmias with Ixmyelocel-T: Results from the ixCELL‑DCM Trial". The poster will be presented by Timothy Henry, M.D., director of cardiology at Cedars-Sinai Heart Institute, principal investigator of the study, and co-author of the poster, on Monday, November 14, 2016 at 2:00pm EDT. The measurement of ventricular arrhythmia episodes resulting in appropriate shocks or ATP (anti-tachycardia pacing) was a pre-specified secondary endpoint of the recently completed ixCELL-DCM trial.
|AHA Poster Session Information|
|Session Title:||Treatments, Trials, and Unique Approaches to Heart Failure Management|
|Poster Title:||Reduction in Ventricular Arrhythmias with Ixmyelocel-T: Results from the ixCELL-DCM Trial|
|Date:||Monday, November 14, 2016, 2:00pm to 3:15pm|
|Location:||Science and Technology Hall, Clinical Science Section|
The poster will be available online at the time of the presentation at http://aha.scientificposters.com.
Ixmyelocel-T is an autologous, expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. Ixmyelocel-T has been designated as an orphan drug by the U.S Food and Drug Administration and is intended for use in the treatment of Dilated Cardiomyopathy Dilated cardiomyopathy (DCM).
About the ixCELL-DCM Clinical Trial
The ixCELL-DCM clinical trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study designed to assess the efficacy, safety, and tolerability of ixmyelocel-T compared to placebo when administered via transendocardial catheter-based injections to patients with end-stage heart failure due to ischemic DCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. The primary endpoint of the ixCELL-DCM clinical trial study was a composite of the number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient and emergency department visits to treat acute decompensated heart failure over the 12 months following administration of ixmyelocel-T compared to placebo. In March 2016, Vericel announced that the trial met its primary endpoint of reduction in clinical events of the composite endpoint, and that there were fewer adverse events and serious adverse events in patients treated with ixmyelocel-T compared with placebo.
About Dilated Cardiomyopathy and Ventricular Arrhythmias
Dilated cardiomyopathy (DCM), a progressive disease of the heart, is a leading cause of heart failure and heart transplantation. DCM is characterized by weakening of the heart muscle and enlargement of the heart chambers, leading to difficulty of the left ventricle to pump blood. Heart enlargement and poor function generally lead to progressive heart failure with further decline in the ability of the heart to pump blood efficiently throughout the body. Ventricular arrhythmias are a form of abnormal heart rhythm that originate in the ventricles of the heart and are common in patients with heart failure and cardiomyopathy. Previous studies have demonstrated an association between ventricular arrhythmias and an increased risk of sudden cardiac death in patients with left ventricular systolic dysfunction due to prior myocardial infarction.
About Vericel Corporation
Vericel develops, manufactures, and markets autologous expanded cell therapies for the treatment of patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel is also developing two additional cell products. MACI® is a third generation autologous chondrocyte implant intended to treat cartilage defects in the knee. Ixmyelocel‑T is an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM). For more information, please visit the company's website at www.vcel.com.
Epicel®, Carticel® and MACI® are registered trademarks of Vericel Corporation. ©2016 Vericel Corporation. All rights reserved.
This document contains forward-looking statements, including, without limitation, statements concerning the clinical protocol for the Phase 2b ixCELL-DCM clinical study of ixmyelocel-T, objectives and expectations regarding ixmyelocel-T and potential for approval, intended product development, clinical activity timing, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "can continue," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements, the availability and allocation of resources among different potential uses, estimating the commercial potential of our product candidates, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel's Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission ("SEC") on March 14, 2016, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management's current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
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