Aastrom Reports Positive 12-Month Results from the RESTORE-CLI Phase 2 Clinical Trial for Ixmyelocel-T in Patients with Criti...
15 November 2011 - 3:15AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
reported positive 12-month final results from the RESTORE-CLI Phase
2 clinical trial of ixmyelocel-T in the treatment of critical limb
ischemia (CLI) patients with no revascularization options. The
results were presented today by William Marston, M.D., chief,
Division of Vascular Surgery, and professor, Department of Surgery,
University of North Carolina, in an oral presentation at the 2011
American Heart Association Scientific Sessions in Orlando, FL.
The randomized, double-blind, placebo-controlled, multicenter
study assessed the safety and efficacy of ixmyelocel-T, a
patient-specific, expanded multicellular therapy for the treatment
of CLI, in a group of 72 patients at one year after treatment.
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 = .0032). Treatment
failure was defined as the first occurrence of any one of the
following: major amputation of the treated leg, all-cause
mortality, doubling of wound total surface area from baseline, or
de novo gangrene. While the study was not powered to show
statistical significance in the secondary endpoint of
amputation-free survival (AFS; major amputation of the treated leg
or all-cause mortality), results from a subgroup of 45 patients
with wounds at baseline showed a positive trend in this measure
(21% ixmyelocel-T treated vs 44% control event rate; p = 0.0802).
The study also met the primary safety endpoint with no differences
between the treated and control groups.
"These results provide substantial additional evidence that
treatment with ixmyelocel-T significantly reduces the risk of
disease progression for CLI patients with no options for
revascularization. Importantly, the efficacy results
demonstrate concordance across all of the defined measures of
treatment failure in the trial," said Dr. Marston. "In
addition, the results related to AFS in the subgroup of patients
with tissue loss similar to those who will be studied in the
upcoming pivotal Phase 3 clinical trial show a strong and
clinically relevant positive trend for such a small number of
patients. These results are especially encouraging since the
primary endpoint for the planned REVIVE-CLI pivotal Phase 3
clinical trial for ixmyelocel-T in no-option CLI patients will be
amputation-free survival."
The RESTORE-CLI Phase 2 clinical trial involved 72 CLI patients
treated at 18 active centers in the United States. Patients
were randomized 2:1 treatment versus placebo. Patients were
treated with a one-time course of 20 intra-muscular injections in
the lower thigh, calf and foot and were then followed for 12
months.
Forty percent of patients treated with ixmyelocel-T in this
study had a treatment failure event compared to 67% of patients in
the placebo group (a statistically significant risk reduction of
62%, p =.0032). In addition, 29% of the placebo group in the trial
experienced their first event to be a doubling in total wound
surface area from baseline in comparison to 10% of patients treated
with ixmyelocel-T. Among patients whose first treatment
failure event was de novo gangrene, the median time that patients
treated with ixmyelocel-T reported the event was day 205 of the
study, while the median time that patients in the placebo group
reported the event was day 19 of the study (a difference of 186
days).
Aastrom will initiate the REVIVE-CLI Phase 3 clinical trial for
ixmyelocel-T this quarter. The study will include 594 CLI
patients with no option for revascularization and existing tissue
loss. The primary endpoint of this study will be
amputation-free survival at 12 months. Patients will be
followed for a total of 18 months from the time of
treatment.
"The 12-month results from our RESTORE-CLI Phase 2 clinical
trial provide compelling clinical evidence that ixmyelocel-T could
represent a major advance in the treatment of patients with CLI who
have no option for revascularization. We look forward to initiating
our pivotal Phase 3 clinical trial for ixmyelocel-T this quarter,"
said Tim Mayleben, Aastrom's president and chief executive
officer.
The presentation slides will be available on the Aastrom web
site today at http://investors.aastrom.com/events.cfm.
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
planned 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. 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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