Vericel Announces Positive Top-Line Results From Phase 2b ixCELL-DCM Clinical Trial of Ixmyelocel-T in Patients With Heart Fa...
11 March 2016 - 12:00AM
Vericel Corporation (NASDAQ:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today announced top-line results
from the company’s Phase 2b ixCELL-DCM clinical trial of
ixmyelocel-T in patients with advanced heart failure due to
ischemic dilated cardiomyopathy (DCM). The trial met its
primary endpoint of demonstrating a reduction in the total number
of deaths, cardiovascular hospitalizations or unplanned outpatient
and emergency department visits to treat acute decompensated heart
failure during the 12 months following treatment with ixmyelocel-T
compared to placebo. All clinical events in the primary and
secondary endpoints were adjudicated in a blinded fashion by an
independent adjudication committee. The incidence of adverse
events, including serious adverse events, in patients treated with
ixmyelocel-T was comparable to patients in the placebo group.
Ixmyelocel-T has been granted orphan product designation by
the U.S. Food and Drug Administration for use in the treatment of
DCM.
“The results of the ixCELL-DCM study, which we believe is the
largest randomized cell therapy trial to treat congestive heart
failure completed to date, demonstrated a statistically significant
and clinically meaningful reduction in cardiac events in patients
who received treatment with ixmyelocel-T compared to placebo,” said
Dr. David Recker, Vericel’s chief medical officer. “We are
very excited about these study results given the lack of treatment
options for end-stage heart failure patients.”
The Phase 2b 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 subjects 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 trial
was designed to provide approximately 80% power to show a 46%
difference in cardiac events for ischemic DCM patients treated with
ixmyelocel-T compared to placebo. A total of 114 patients
were treated in the ixCELL-DCM clinical trial at 28 sites in the
United States.
The full data results from the ixCELL-DCM trial are scheduled to
be presented at the upcoming Late-Breaking Clinical Trial Sessions
of the American College of Cardiology 65th Annual Scientific
Session & Expo on April 4, 2016, and also will be submitted for
publication.
About Dilated CardiomyopathyDilated
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 systolic abnormalities
(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.
About Ixmyelocel-TIxmyelocel-T is a
patient-specific, 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 for use in the treatment of 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 (vehicle control) when administered via transendocardial
catheter-based injections to subjects 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 is 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.
About Vericel CorporationVericel Corporation is
a leader in developing patient-specific expanded cellular therapies
for use in the treatment of patients with severe diseases and
conditions. The company markets two autologous cell therapy
products in the U.S.: Carticel® (autologous cultured chondrocytes),
an autologous chondrocyte implant for the treatment of cartilage
defects in the knee, and Epicel® (cultured epidermal autografts), a
permanent skin replacement for the treatment of patients with
deep-dermal or full-thickness burns comprising greater than or
equal to 30% of total body surface area. Vericel is also
developing MACI™, a third-generation autologous chondrocyte implant
for the treatment of cartilage defects in the knee, and
ixmyelocel-T, a patient-specific multicellular therapy for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy. For more information, please visit the
company’s website at www.vcel.com.
Epicel® and Carticel® are registered trademarks and MACI™ is a
trademark of Vericel Corporation. © 2016 Vericel
Corporation. All rights reserved.
This document contains forward-looking statements, including,
without limitation, statements concerning anticipated progress,
objectives and expectations regarding the commercial potential of
our products, intended product development, relative size of
clinical trials, clinical activity timing and regulatory pathway
and 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 clinical
trial and product development activities and regulatory approval
requirements. 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, 2014, filed with the Securities and
Exchange Commission ("SEC") on March 25, 2015, 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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