Vericel Completes Patient Enrollment in Phase 2b ixCELL-DCM Clinical Study of Ixmyelocel-T
January 29 2015 - 08:45AM
Vericel Corporation (Nasdaq:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today announced the completion of
patient enrollment in the company's Phase 2b ixCELL-DCM clinical
trial evaluating ixmyelocel-T for the treatment of advanced heart
failure due to ischemic dilated cardiomyopathy (DCM). Top-line
results from this study are expected around the end of the first
quarter of 2016.
"The ixCELL-DCM study is progressing on schedule and should
generate valuable new information about the clinical potential of
ixmyelocel-T to treat patients who suffer from advanced heart
failure due to ischemic DCM," said David Recker, MD, Vericel's
chief medical officer. "We congratulate our clinical investigators
on reaching this milestone and thank our study participants, the
ixCELL-DCM study steering committee and the independent data and
safety monitoring board for their support and commitment to this
important research program."
About Dilated Cardiomyopathy
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 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 an
orphan drug by the U.S. Food and Drug Administration for use in the
treatment of DCM.
About Vericel Corporation
Vericel Corporation (formerly Aastrom Biosciences, Inc.) 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 United States: 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 percent 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.
This document contains forward-looking statements, including,
without limitation, statements concerning anticipated progress,
objectives and expectations often, but 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," "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, integration
of the acquired business, 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 products and product candidates and
growth in revenues, 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, 2013,
filed with the Securities and Exchange Commission ("SEC") on March
13, 2014, 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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