Aastrom Receives FDA Fast Track Designation for Phase 3 CLI Program
18 October 2010 - 11:30PM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of
expanded autologous cellular therapies for the treatment of severe
cardiovascular diseases, today announced that the U.S. Food &
Drug Administration (FDA) has granted fast track designation for
the company's critical limb ischemia (CLI) cell therapy development
program. Aastrom plans to initiate Phase 3 clinical testing of its
treatment for CLI in early 2011.
"Fast track designation is an important step for our CLI program
and underscores the importance of finding an effective treatment
option for this devastating disease," said Tim Mayleben, president
and CEO of Aastrom. "It may also accelerate the timing of our
regulatory submissions to the FDA and expedite FDA review of our
marketing application once Phase 3 testing is completed. We greatly
appreciate the FDA's support of this important clinical
program."
The FDA's fast track program is designed to facilitate the
development and expedite the review of new drugs and biologics
intended to treat serious or life-threatening conditions and that
demonstrate the potential to address unmet medical needs. Fast
track-designated drugs and biologics ordinarily qualify for
priority review, thereby expediting the review process. In
addition, the designation may allow Aastrom to submit portions of
the Therapeutic Biologic Application on a rolling submission
basis.
CLI is the most severe form of peripheral artery disease,
leading to over 160,000 major limb amputations per year in the U.S.
Approximately 25% of patients will die within the 6-12 months
following diagnosis, and less than 25% of patients survive four
years. Therapeutic and surgical options are limited and often
ineffective for the most severely affected patients.
About Aastrom Biosciences
Aastrom Biosciences is developing expanded autologous cellular
therapies for the treatment of severe cardiovascular diseases. The
company's proprietary cell manufacturing technology enables the
production of cellular 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, disease treatment and progression,
operating results, spending activities, patient symptoms and
responses to treatment, treatment options 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: Berry & Company
Media contact
Stephen Zoegall
212 253-8881
szoegall@berrypr.com
Aastrom Biosciences
Investor contact
Kimberli O'Meara
734 930-5777
ir@aastrom.com
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