Aastrom Biosciences Announces Initiation of Patient Enrollment in REVIVE Phase 3 Clinical Trial of Ixmyelocel-T
01 March 2012 - 8:30AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific expanded multicellular therapies for the treatment
of severe chronic cardiovascular diseases, has begun patient
enrollment in the REVIVE Phase 3 clinical trial to assess the
efficacy and safety of ixmyelocel-T in the treatment of patients
with critical limb ischemia (CLI). The primary endpoint of the
trial will be amputation-free survival at 12 months. REVIVE is the
largest randomized, double-blind, placebo-controlled, multicenter
study ever conducted in patients with CLI.
The Phase 3 trial will be conducted at 80 sites in the United
States and will include 594 CLI patients who have no option for
revascularization and also have existing tissue loss due to
ischemia. Patients will be followed for a total of 18 months,
including 12 months from randomization for efficacy and an
additional six months for safety.
"The initiation of our REVIVE Phase 3 trial represents a major
achievement in our effort to advance ixmyelocel-T through the final
phase of clinical development and regulatory review. We are
all very excited about the potential to rapidly bring this
important new therapy through development to benefit the hundreds
of thousands of CLI patients who have no other good treatment
options available," said Tim Mayleben, Aastrom Biosciences
president and chief executive officer.
This REVIVE clinical trial is supported by an independent
steering committee of renowned leaders in vascular medicine and
clinical research who will provide independent oversight as well as
medical and clinical guidance. Members of the steering committee
assisted Aastrom in reaching final agreement on a Special Protocol
Assessment (SPA) from the FDA for the Phase 3 study. The REVIVE
clinical trial has also been granted Fast Track designation by the
FDA.
"The initiation of this landmark study is the result of
extensive interactions with the FDA in a Special Protocol
Assessment review process designed to ensure the integrity of both
the cellular therapy product and the clinical trial to evaluate a
novel therapy in a critically ill patient population," said William
R. Hiatt, MD, professor of medicine, University of Colorado, and
president of CPC Clinical Research, a non-profit academic research
organization. Dr. Hiatt is head of the independent steering
committee for the REVIVE Phase 3 study. CPC Clinical Research
provides quality control services for the collection of endpoint
data for the REVIVE clinical trial.
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 3 clinical program to study patients with critical limb
ischemia and a planned Phase 2b clinical trial in patients with
ischemic dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com. For more information on
the pivotal REVIVE Phase 3 clinical trial, please visit the trial
website at www.revivecli.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 or Transition Report on Form 10-K or
10-K/T, 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
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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