Aastrom Announces Results of Two Studies of Ixmyelocel-T Published in Stem Cell Research & Therapy
November 01 2013 - 11:10AM
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 two separate research studies involving ixmyelocel-T,
the company's lead product candidate, were published in the peer
reviewed journal Stem Cell Research & Therapy.
Results from the first study, "Ixmyelocel-T, an Expanded
Multicellular Therapy, Contains a Unique Population of M2-Like
Macrophages", show that ixmyelocel-T contains M2-like macrophages
characterized by expression of multiple, well-known M2 macrophage
markers, decreased secretion of pro-inflammatory cytokines after
inflammatory stimuli, and efficient removal of apoptotic cells. The
population of macrophages generated in ixmyelocel-T is believed to
play a role in tissue repair and regeneration.
"Our data demonstrate that ixmyelocel-T therapy contains a
unique population of M2-like macrophages characterized by secretion
of anti-inflammatory cytokines and expression of M2 markers CD206
and CD163. In addition to being involved in efficient removal
of apoptotic cells, they also show elevated expression of MerTK,
which is essential in limiting tissue injury and promoting repair.
These findings provide further indication that these cells
may play a key role in the treatment of diseases where tissue
remodeling and immunomodulation are components of successful
clinical outcomes," said Dr. Ronnda Bartel, chief scientific
officer, Aastrom Biosciences. "We believe that this research also
represents the first successful ex-vivo expansion of these
anti-inflammatory cells."
In the second study, titled "Potential Beneficial Effects of
Ixmyelocel-T in the Treatment of Atherosclerotic Diseases",
ixmyelocel-T was treated with modified low-density lipoprotein
(LDL) similar to that found in atherosclerotic plaques. The
amounts of LDL uptake and expression of cytokines and key
cholesterol transport genes were then measured in an attempt to
mimic the pro-inflammatory environment in atherosclerotic lesions.
The results of these analyses showed that ixmyelocel-T macrophages
are able to influx modified cholesterol, remain anti-inflammatory
in the face of lipid loading and inflammatory challenge, and
display enhanced cholesterol efflux capabilities.
"This study indicates that the unique M2-like population of
macrophages found in ixmyelocel-T is efficient at maintaining
cholesterol homeostasis. As a result, ixmyelocel-T macrophages
may exert highly beneficial effects and represent a potential new
modality in the treatment of atherosclerotic disease," Dr. Bartel
said.
Ixmyelocel-T is a patient-specific multicellular therapy
expanded from a patient's own bone marrow. It is currently being
evaluated in a Phase 2b clinical trial for treatment of advanced
heart failure due to ischemic dilated cardiomyopathy (DCM). The
Phase 2a trial in DCM patients confirmed that ixmyelocel-T was
well-tolerated and that efficacy observations were consistent with
improved function of impaired myocardium. Health Canada recently
approved the company's application to initiate this clinical trial
in Canada. Aastrom is also continuing to follow patients treated in
the REVIVE Phase 3 clinical trial of ixmyelocel-T in the treatment
of critical limb ischemia. Preclinical studies of ixmyelocel-T
are in progress in atherosclerosis and fibrosis. Researchers
at the University of Michigan are also studying the use of
ixmyelocel-T in the treatment of craniofacial
augmentation. Ixmyelocel-T is manufactured using Aastrom's
proprietary, highly automated, fully closed cell-processing
system.
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 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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