Aastrom Announces Treatment of Final Patient in RESTORE-CLI Clinical Trial
March 24 2010 - 8:30AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of
autologous cellular therapies for the treatment of severe
cardiovascular diseases, today reported that the final patient has
been treated in the company's ongoing multi-center, randomized,
double-blind, placebo-controlled U.S. Phase 2b clinical trial
designated RESTORE-CLI. This patient received intramuscular
injections of either Aastrom's tissue repair cells (TRCs) or
electrolyte solution (placebo) for the treatment of critical limb
ischemia (CLI), the end-stage of peripheral arterial disease.
People with CLI face a high risk of amputation and, in some cases,
death. Approximately 1 million people in the U.S. suffer from CLI,
which results in more than 160,000 amputations each year.
Aastrom's RESTORE-CLI trial is the largest double-blind,
randomized cell therapy study currently being conducted for CLI.
The trial has enrolled a total of 86 patients at 18 sites in the
United States. Patients in the treatment group received
intramuscular injections of TRCs into the affected limb, while
control patients received intramuscular injections with an
electrolyte solution (without cells). Both groups also received
appropriate standard of care for their condition. While the primary
objective of this trial is to assess safety in patients with CLI,
additional efficacy measures are also being monitored, including
time to treatment failure (where failure is defined as major
amputation, doubling of wound size or new gangrene), amputation
rate, wound size and severity. Ankle brachial pressure index, pain
and quality of life are also being monitored. Patients are being
evaluated at both six months and 12 months following treatment.
"We are pleased to announce this milestone in our vascular
regeneration program," said Tim Mayleben, president and CEO of
Aastrom. "With the treatment of the final patient in this trial, we
are well-positioned to report six-month interim results for all
enrolled patients later this year and initiate planning for a
pivotal Phase 3 vascular trial."
TRC-based cellular therapies are produced from a small sample of
bone marrow taken from a patient. Aastrom's TRC technology greatly
expands the cell populations for direct delivery to the damaged
tissues of the same patient.
About Aastrom Biosciences
Aastrom Biosciences is developing autologous cellular therapies
for use in the treatment of severe cardiovascular diseases. The
company's proprietary cell-processing technology enables the
production of cellular therapies using a patient's own bone marrow
that can be delivered directly to damaged tissues. Aastrom has
advanced this technology into late-stage clinical development and
is conducting two Phase 2 clinical trials to treat dilated
cardiomyopathy and a Phase 2b clinical trial to treat critical limb
ischemia. 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
expectations, clinical activity timing, intended product
development and commercialization objectives, expected timing of
collecting and analyzing treatment data and possible communications
with the U.S. Food and Drug Administration, 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:
Stephen Zoegall
(212) 253-8881
szoegall@berrypr.com
Aastrom Biosciences, Inc.
Investors:
Kimberli O'Meara
(734) 930-5777
ir@aastrom.com
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