Aastrom Biosciences Announces First Patients Treated in ixCELL-DCM Clinical Study of ixmyelocel-T
19 April 2013 - 11:00PM
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 first patients were treated in the ixCELL-DCM Phase 2b clinical
trial. This study is evaluating the safety and efficacy of
ixmyelocel-T compared to placebo in patients with advanced heart
failure due to ischemic dilated cardiomyopathy (ischemic DCM).
Aastrom has received U.S. orphan drug designation for the use of
ixmyelocel-T in patients with DCM.
"There is an unmet need for additional treatment options for DCM
as this condition significantly reduces quality of life and places
patients at high risk of multiple hospitalizations and increased
mortality. The survival rate for DCM drops to just 30% after five
years. Ixmyelocel-T has been shown to promote tissue repair in
the heart, which can potentially improve outcomes for the hundreds
of thousands of people who suffer from advanced heart failure,"
said Dr. Safwan Kassas, interventional cardiologist, director of
the stem cell and regenerative medicine program at the Michigan
CardioVascular Institute/Covenant Medical Center and principal
investigator in the ixCELL-DCM trial.
The ixCELL-DCM trial is a randomized, double-blind,
placebo-controlled phase 2b study with a planned enrollment of 108
patients at approximately 30 sites in the U.S. In the study,
ixmyelocel-T will be administered via catheter-based injections to
patients with advanced heart failure due to ischemic DCM. The
primary endpoint of the trial will be the average number of events
per patient, which include all-cause mortality, all-cause
hospitalizations or unplanned hospital visits to treat worsening
heart failure over 12 months.
"We are very enthusiastic about evaluating the therapeutic
potential of ixmyelocel-T to treat patients with DCM, and grateful
to our study coordinators and investigators for their progress in
moving this important clinical program forward," said Nick
Colangelo, president and chief executive officer at Aastrom
Biosciences.
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 a
Phase 2b clinical trial in patients with 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 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 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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