Final Results from RESTORE-CLI Phase 2b Clinical Trial for Ixmyelocel-T in Treatment of Critical Limb Ischemia Published in t...
05 April 2012 - 11:00PM
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
final results from the company's RESTORE-CLI Phase 2b clinical
trial for ixmyelocel-T were published in the peer-reviewed journal
Molecular Therapy. The Phase 2b clinical results demonstrated that
treatment with ixmyelocel-T improved time to treatment failure in
patients with critical limb ischemia (CLI) compared to the control
group, and in the subgroup of patients with wounds at baseline
demonstrated an improvement in amputation free survival.
The RESTORE-CLI study was a randomized double blind Phase 2b
clinical trial comparing the efficacy and safety of ixmyelocel-T to
placebo. Patients received a one-time treatment of ixmyelocel-T of
20 intramuscular injections in the treated leg and were followed
for 12 months. The results also showed no major safety issues
associated with treatment with ixmyelocel-T.
"These results clearly suggest that ixmyelocel-T has the
potential to be a promising treatment option in patients with CLI
who are not eligible for revascularization. This study represents
an important advance in research related to regenerative medicine
and the treatment of CLI patients," said Richard J. Powell, M.D.,
section chief of vascular surgery at the Dartmouth-Hitchcock
Medical Center in Lebanon, NH, and a co-principal investigator of
the RESTORE-CLI clinical trial. CLI is the most severe form of
peripheral arterial disease (PAD) caused by chronic inflammatory
processes associated with atherosclerosis that result in markedly
reduced blood flow to the legs, feet and hands. Patients are
considered "no option" because they are unable to have
revascularization surgery to treat their CLI disease. Major
amputation may be necessary for these patients.
In the study, efficacy assessments included time to first
occurrence of treatment failure, defined as major amputation,
all-cause mortality, doubling of total wound surface area from
baseline, or de novo gangrene. A total of 48 patients were
treated with ixmyelocel-T and 24 received a placebo. Adverse
event rates in both groups were similar. Patients in the treatment
arm showed a 62% reduction in risk relative to placebo in the
primary efficacy endpoint of time to first occurrence of treatment
failure (p =0.0032). A post hoc analysis of the subgroup of 45
patients with wounds at baseline resulted in a 77% risk reduction
in time to first occurrence of treatment failure (p=0.0002) and a
positive trend in the Phase 3 endpoint of amputation-free survival
(61% risk reduction, p=0.0915).
"Based on the results of our RESTORE-CLI study, we recently
initiated the Phase 3 REVIVE clinical trial at 80 treatment centers
across the U.S. We continue to see very strong promise
resulting from our development efforts, and are working
aggressively to complete the Phase 3 trial and position
ixmyelocel-T for the final phase of regulatory review," said Tim
Mayleben, Aastrom president and chief executive officer.
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 two Phase 2 clinical trials in patients with 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
Bill Berry
Berry & Company
bberry@berrypr.com
(212) 253-8881
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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