Vericel Announces Publication of Clinical Trial Rationale and Study Design for the Phase 2b ixCELL-DCM Trial of Ixmyelocel-T ...
28 March 2016 - 11:30PM
Vericel Corporation (NASDAQ:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today announced the publication of
the clinical trial rationale and study design for the company’s
Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with
advanced heart failure due to ischemic dilated cardiomyopathy (DCM)
in the journal Cell Transplantation.
On March 10, 2016, Vericel announced that the ixCELL-DCM 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. The
ixCELL-DCM trial is believed to be the largest randomized,
double-blind, placebo-controlled cell therapy clinical trial to
treat heart failure due to ischemic DCM completed to date.
The publication by Dr. Timothy Henry and colleagues (Henry T.D.,
Schaer G., Demaria A., et al., The ixCell-DCM Trial:
Rationale and Design, Cell Transplantation, 2016) describes the
study design, study population, treatment preparation and protocol,
clinical endpoints, and statistical analysis plan for the
ixCELL-DCM clinical trial.
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. 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, the
clinical protocol and statistical plan for the Phase 2b ixCELL-DCM
clinical study of ixmyelocel-T, objectives and expectations
regarding ixmylocel-T, 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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