Vericel Corporation (NASDAQ:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today announced the presentation
and publication of results from the company’s Phase 2b ixCELL-DCM
clinical study of ixmyelocel-T in patients with advanced heart
failure due to ischemic dilated cardiomyopathy (DCM). The
data were presented today by Timothy Henry, M.D., at the
Late-Breaking Clinical Trial Session and press conference at the
American College of Cardiology’s (ACC) 65th Annual Scientific
Session and published in The Lancet. Dr. Henry is director of
cardiology at Cedars-Sinai Heart Institute, principal investigator
of the study and co-author of the Lancet publication.
“The ixCELL-DCM study met its primary endpoint of demonstrating
a reduction in the total number of all-cause 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,”
said Dr. David Recker, Vericel’s chief medical officer. “From
a safety perspective, the incidence of adverse events, including
serious adverse events, in patients treated with ixmyelocel-T was
comparable to or lower than patients in the placebo group. We
are very excited about the results of this clinical trial and
greatly appreciate the contributions of the patients, investigators
and dedicated personnel who participated in this study.”
“We have a major unmet need in the treatment of class III and IV
heart failure,” said Amit N. Patel, M.D., director of clinical
regenerative medicine and associate professor of surgery at the
University of Utah and the Chair of the ixCELL-DCM Steering
Committee. “Based on these positive results, we are
encouraged that ixmyelocel-T has the potential, if approved, to
represent an important new option for patients with class III and
class IV heart failure due to ischemic cardiomyopathy.”
The ixCELL-DCM clinical trial is a multicenter, randomized
(1:1), double-blind, placebo-controlled Phase 2b study 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. A total of 126 patients with New York
Heart Association (NYHA) Class III or IV heart failure were
randomly assigned to receive either ixmyelocel-T or placebo, and
114 patients were treated at 28 sites in the United
States. All clinical events in the primary and
secondary endpoints were adjudicated in a blinded fashion by an
independent adjudication committee.
The trial met its primary endpoint with patients in the
ixmyelocel-T group having a 37 percent reduction in all-cause
deaths, cardiovascular hospitalizations, or unplanned outpatient
and emergency department visits to treat acute decompensated heart
failure during the 12 months following treatment compared to the
placebo group (p=0.0344). The primary endpoint was driven by
a reduction in both all-cause deaths and cardiovascular
hospitalizations. In the primary endpoint without
procedure-related events, three percent of patients in the
ixmyelocel-T group died and 38 percent had cardiovascular
hospitalizations one or more times, compared to 14 percent and 47
percent, respectively, in the placebo group. All deaths were
adjudicated to be due to cardiovascular causes.
With respect to the secondary endpoints of the trial, the
components of the primary endpoint were also analyzed using the Win
ratio in a hierarchical manner to incorporate both the incidence
and timing of the endpoint components. The Win ratio result
of 1.56 showed that more often ixmyelocel-T was the “winner” in
that the time to death, left ventricular assist device placement,
heart transplantation or time to cardiovascular hospitalization was
shorter for placebo-treated patients, but this difference did not
reach statistical significance. The time to first event was
longer in the ixmyelocel-T group compared to placebo, but was not
statistically significant. There were no significant
structural changes in left ventricle cavity size or left
ventricular ejection fraction as measured by echocardiogram in
either the ixmyelocel-T or placebo groups. Both treatment
groups had an improvement in the NYHA class and six minute walk
test, with no statistical difference between the groups at month 12
using last observation carried forward.
Overall, there were fewer adverse events and serious adverse
events in the ixmyelocel-T group compared to the placebo group.
Adverse events included those typically related to
catheterization or injection procedures.
The ixCELL-DCM trial showed a statistically significant
reduction in clinical events driven by both cardiac mortality and
cardiac hospitalizations at 12 months compared to placebo.
These results are consistent with two previous Phase 2a studies
which showed that ischemic DCM patients treated with ixmyelocel-T
experienced fewer major adverse cardiovascular events during follow
up compared to control patients.
Vericel will host a webcast at 12:00pm ET on Tuesday, April 5,
2016 to review ixmyelocel-T and the Phase 2b ixCELL-DCM trial
results. Dr. Gary L. Schaer, M.D., of Rush University
Medical Center and a member of the ixCELL-DCM Steering
Committee, will present an overview of the results from the
ixCELL-DCM clinical trial and Dr. Ross Tubo, Vericel’s chief
scientific officer, will present additional background information
on ixmyelocel-T and describe the potential benefits of expanded
multicellular therapy in the repair and regeneration of ischemic
tissue. The live webcast and a recording will be available at
the events and presentations section of the Vericel website at
investors.vcel.com/events.cfm. Both the Lancet publication
and the ACC Scientific Sessions presentation, as well as additional
data and analysis not presented at ACC, are currently available at
investors.vcel.com/events.cfm.
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-T Ixmyelocel-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. 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 the clinical protocol and
statistical plan 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 and growth in
revenues and improvement in costs, 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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