Aastrom Announces Key Manufacturing Milestone and New Generic Name for Its Cell Therapy Product
April 04 2011 - 8:00AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of
expanded, patient-specific cellular therapies for the treatment of
severe, chronic cardiovascular diseases, announced today that it
has completed an important product manufacturing milestone with the
transfer of cell cassette manufacturing to ATEK Medical under the
strategic partnership announced in October 2010. These single-use
cell cassettes are the central component used in Aastrom's
proprietary culturing process at its cell manufacturing facility in
Ann Arbor, Michigan.
"As a result of this milestone, which we achieved ahead of
schedule, we now have a fully validated and reliable manufacturing
partner to support our late stage clinical development programs,"
said Tim Mayleben, president and CEO of Aastrom. "This will ensure
that Aastrom has the inventory of high-quality cell cassettes
necessary for the planned mid-2011 start of our Phase 3 clinical
program in critical limb ischemia."
In addition, Aastrom announced today that ixmyelocel-T has been
formally accepted by the U.S. Food and Drug Administration's Center
for Biologics Evaluation and Research and the United States Adopted
Names Council as the non-proprietary name for Aastrom's
investigational cell therapy product.
"We also reached an important product development milestone with
the selection of ixmyelocel-T as the generic name of our expanded
cell therapy product," Mr. Mayleben added. "This name was reviewed
and accepted by the FDA and USAN Council and will be used by us and
our collaborators going forward."
About Aastrom Biosciences
Aastrom Biosciences is developing expanded patient-specific
cellular therapies for use in the treatment of severe, chronic
cardiovascular diseases. The company's proprietary cell-processing
technology enables the manufacture of mixed-cell therapies expanded
from a patient's own bone marrow and delivered directly to damaged
tissues. Aastrom has advanced its cell therapies into late-stage
clinical development, including a planned Phase 3 clinical program
for the treatment of patients with critical limb ischemia and two
ongoing Phase 2 clinical trials in patients with 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 and investor contact
Bill Berry
Berry & Company
212 253-8881
ir@aastrom.com
bberry@berrypr.com
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