Aastrom Biosciences Announces First Patients Enrolled in ixCELL-DCM Phase 2b Clinical Trial of Ixmyelocel-T
05 April 2013 - 12:00AM
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
first patients have been enrolled in the ixCELL-DCM clinical trial.
This Phase 2b study is currently underway in the United States to
assess the efficacy and safety of ixmyelocel-T in the treatment of
patients with advanced heart failure due to ischemic dilated
cardiomyopathy (ischemic DCM).
"Enrolling the first patients in the ixCELL-DCM trial is an
important milestone in our effort to bring this potential new
treatment for advanced heart failure to thousands of people who
might benefit from it," said David Recker, M.D., acting chief
medical officer at Aastrom Biosciences.
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. Patients will be followed for a total of 12
months.
"We recently refocused our clinical program on the development
of ixmyelocel-T for the treatment of dilated cardiomyopathy and
other rare disease indications and are delighted to enroll our
first patients in the ixCELL-DCM study," said Nick Colangelo,
president and chief executive officer at Aastrom Biosciences. "We
have increased the number of sites participating in this study
which will help us build momentum in patient enrollment and
complete the trial on schedule."
For more information on ischemic DCM and ixmyelocel-T, visit
http://www.aastrom.com/cardiovascular-disease-patients/living-with-dcm-video/
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
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Jun 2024 to Jul 2024
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Jul 2023 to Jul 2024