Aastrom Reports Data and Safety Monitoring Board Recommendation to Continue ixCELL-DCM Clinical Trial
April 09 2014 - 9:00AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
announced that the independent Data and Safety Monitoring Board
(DSMB) for the company's ixCELL-DCM Phase 2b clinical trial has
recommended continuing the study without modification as planned
following an interim review of unblinded safety data from the
trial.
The ixCELL-DCM clinical trial is a randomized, double-blind,
placebo-controlled phase 2b study evaluating ixmyelocel-T for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy. More than 30 clinical trial sites are active in the
U.S. and Canada and enrollment is expected to be completed in the
second half of 2014. The DSMB, which reviews unblinded safety data
from the trial on a periodic basis, is comprised of independent
third-party experts in cardiovascular medicine, stem cell research
and biostatistics.
"We are very pleased with the DSMB's recommendation to continue
the ixCELL-DCM clinical trial as planned and appreciate the DSMB's
ongoing efforts in overseeing the safety aspects of the study,"
said David Recker, MD, FACR, FACP, chief medical officer of
Aastrom. "We also appreciate the strong commitment of our expert
interventional cardiology investigators to this important clinical
trial and their continued efforts to complete enrollment of the
trial this year."
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular diseases.
The company's proprietary cell-processing technology enables the
manufacture of ixmyelocel-T, a patient-specific multicellular
therapy expanded from a patient's own bone marrow and delivered
directly to damaged tissues. Aastrom has advanced ixmyelocel-T into
late-stage clinical development, including the Phase 2b ixCELL-DCM
clinical trial in patients with advanced heart failure due to
ischemic dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including,
without limitation, statements concerning clinical trial plans and
progress, objectives and expectations, clinical activity timing,
intended product development, the performance and contribution of
certain individuals and expected timing of collecting and analyzing
treatment data, 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," "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 the
closing of the offering described herein, Aastrom's intended use of
proceeds in connection with the offering, clinical trial and
product development activities, regulatory approval requirements,
competitive developments, and the availability of resources and the
allocation of resources among different potential uses. These and
other significant factors are discussed in greater detail in
Aastrom's Registration Statement on Form S-1 described above,
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
other filings with the Securities and Exchange Commission. These
forward-looking statements reflect management's current views and
Aastrom 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: Media contact:
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact:
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
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