Vericel to Present Data at the American Heart Association’s Scientific Sessions 2016 on the Reduction of Ventricular Arrhyt...
September 07 2016 - 8:00AM
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 Number: |
19491 |
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 |
Link |
http://abstractsonline.com/pp8/#!/4096/presentation/55711 |
The poster will be available online at the time of the
presentation at http://aha.scientificposters.com.
About Ixmyelocel-TIxmyelocel-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 TrialThe
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
ArrhythmiasDilated 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.
CONTACT:
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
or
Lee Stern
The Trout Group
lstern@troutgroup.com
(646) 378-2922
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