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Aastrom Biosciences, Inc.
, 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.
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