UPDATE: Aastrom Biosciences to Stop Enrollment/End Phase 3 REVIVE CLI Study, to Shift Focus to Phase 2B ixCELL-DCM Study
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.
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