* Focus shifted to Phase 2b ixCELL-DCM clinical study and the development of ixmyelocel-T for
dilated cardiomyopathy, an orphan drug indication.
* Company to stop enrollment and end Phase 3 REVIVE CLI study following strategic program review.
* Corporate restructuring will significantly reduce operating expenses and capital requirements.
ANN ARBOR, Mich., March 27, 2013 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the
leading developer of patient-specific expanded multicellular therapies for the treatment of severe
chronic cardiovascular diseases, today announced a strategic change in its research and
development programs to focus on the clinical development of its lead product, ixmyelocel-T, for
the treatment of dilated cardiomyopathy (DCM). Aastrom, which recently initiated the Phase 2b
ixCELL-DCM clinical trial, previously received a U.S. orphan drug designation for the use of
ixmyelocel-T in the treatment of DCM. As a result of the strategic change, Aastrom will stop
enrollment and end the Phase 3 REVIVE clinical trial in patients with critical limb ischemia
(CLI). In addition, the company is executing a corporate restructuring that will reduce staff and
operating expenses by approximately 50 percent.
Nick Colangelo, president and chief executive officer of Aastrom, stated: "We completed our
strategic review of the CLI program, including an evaluation of the challenges in enrolling
patients in the REVIVE study and a recent determination that the CLI program would not be
supported by a partner in a timeframe that would impact the pace of enrollment of the study. Based
on this review, we have decided that the best path to commercialization of ixmyelocel-T is to
focus aggressively on the DCM program. We will begin treating patients in the Phase 2b ixCELL-DCM
clinical study within the next few weeks. In our earlier Phase 2a DCM clinical trials,
ixmyelocel-T was well-tolerated and efficacy observations were consistent with improved function
of impaired myocardium in patients with DCM. In addition, preclinical results demonstrated that
ixmyelocel-T was protective of ischemic heart tissue in a murine model of heart failure. These
findings strongly support the decision to focus our resources on the development of ixmyelocel-T
for the DCM orphan indication."
The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled Phase 2b study.
Approximately 108 patients will be enrolled at about 30 sites in the U.S. In the study,
ixmyelocel-T is administered via catheter-based injections to patients with advanced heart failure
due to ischemic DCM. The primary endpoint of the trial is the average number of events per
patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital
visits to treat worsening heart failure. Patients will be followed for a total of 12 months.
Mr. Colangelo added: "We appreciate the contributions of all of the participants in the REVIVE
clinical program and continue to believe that ixmyelocel-T has great therapeutic potential to
treat patients with CLI. Our Phase 2b results demonstrated that ixmyelocel-T was efficacious and
well-tolerated in patients with CLI. However, we have determined that the optimal use of our
resources at this time is to focus on the development of ixmyelocel-T for DCM and other rare
disease indications where clinical development may require smaller studies with lower costs and a
shorter path to regulatory approval. We also plan to continue to explore the use of our
proprietary Aastrom Replicell system to develop new cell therapy products for other areas of unmet
He further stated: "This was a difficult but necessary decision, and I appreciate the diligence
and support of my colleagues in our effort to define the best path forward for Aastrom. Based on
all of these considerations, I believe this is the right course of action for our company and the
best way to create sustainable long-term value for our shareholders."
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
2b clinical trial in patients with ischemic dilated cardiomyopathy. For more information, please
visit Aastrom's website at www.aastrom.com
The Aastrom Biosciences, Inc. logo is available at
This document contains forward-looking statements, including, without limitation, statements
concerning clinical trial plans and progress, objectives and expectations, clinical activity
timing, including the timing and expenses associated with winding down the CLI trial, intended
product development, restructuring plans, 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, the
ability to execute on our restructuring plans and successfully reduce expenses, the unproven
nature ofour proprietary Aastrom Replicell system 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.
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