Aastrom to Present Results of Phase 2a Clinical Trial of Ixmyelocel-T in Dilated Cardiomyopathy Patients at SCAI Scientific S...
May 07 2012 - 3:30PM
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 results from the company's Phase 2a clinical trial
of ixmyelocel-T in the treatment of dilated cardiomyopathy (DCM)
will be presented at the Society for Cardiovascular Angiography and
Interventions (SCAI) Scientific Sessions held May 9-12, 2012 in Las
Vegas, Nevada. The Aastrom presentation, entitled "Safety and
Efficacy of Ixmyelocel-T, An Expanded Patient-Specific Mixed Cell
Therapy, in Dilated Cardiomyopathy," will be made on Thursday, May
10, at 12:26 p.m. during the late-breaking clinical trials session.
The presentation will be given by Timothy D. Henry, MD, FACC,
director of research at the Minneapolis Heart Institute Foundation.
The Phase 2a clinical trial was designed to evaluate the safety
and efficacy of intramyocardial delivery of ixmyelocel-T, Aastrom's
investigational, patient-specific, multicellular therapy expanded
from a patient's own bone marrow. Ixmyelocel-T is comprised of many
of the same cell types as those found in the bone marrow and,
importantly, expanded populations of CD90+ mesenchymal stromal
cells (MSCs) and CD14+auto+ M2 macrophage cells. Ixmyelocel-T
provides multiple reparative activities including resolution of
chronic inflammation, remodeling of ischemic tissue and promotion
of angiogenesis.
In this study, ixmyelocel-T was evaluated in ischemic and
non-ischemic DCM patients with class III/IV heart failure as
defined by the New York Heart Association and with limited
treatment options. The study included 22 patients who were
randomized 2 to 1 and followed for 12 months.
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 3 clinical program to study patients with critical limb
ischemia and two Phase 2 clinical trials in patients with ischemic
dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com. For more information on
the pivotal REVIVE Phase 3 clinical trial, please visit the trial
website at www.revivecli.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 or Transition Report on Form 10-K or
10-K/T, 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
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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