Our recent decision to implement a strategic change in our R&D programs to focus on the development of ixmyelocel-T for the treatment of dilated cardiomyopathy (DCM) and stop enrollment in the Phase 3 REVIVE trial in critical limb ischemia (CLI) reflects the significant opportunity that we see to treat advanced heart failure caused by DCM and the challenges that we faced in enrolling the REVIVE study in a reasonable timeframe.  While we believe that ixmyelocel-T has strong therapeutic potential to treat CLI, based on previous clinical results showing that ixmyelocel-T was efficacious and well-tolerated in this patient population, the decision was based on our need to allocate resources to advance ixmyelocel-T toward commercialization as quickly as possible.  We believe that the DCM program represents our best near-term opportunity to accomplish this goal.

Our previous results in DCM —in both preclinical and clinical studies — suggest that our patient-specific multicellular therapy can produce a range of clinical benefits for patients with severe heart failure whose limited treatment options include heart transplantation. The rationale for developing ixmyelocel-T in this orphan disease indication is compelling, and we are delighted to announce enrollment of the first patients in the ixCELL-DCM clinical trial this week.  We look forward to completing enrollment in this clinical trial early next year and to reporting our results in 2015.

In our continuing research during the past year, we have learned a great deal more about the therapeutic activity of the cells comprising ixmyelocel-T.  These findings will enable us to identify new therapeutic applications for ixmyelocel-T and our cell-production technology for the treatment of other rare diseases.  Importantly, this research positions us to target applications that can be evaluated with relatively smaller clinical studies through a more streamlined regulatory pathway.  We look forward to broadening our research platform to explore these exciting new product opportunities.

Like most other biotech companies developing novel therapies, Aastrom will need to raise additional capital, and we are currently evaluating several financing options.  Our recent restructuring which reduces our operating expenses by half, our progress in launching the DCM Phase 2b clinical program and our efficient manufacturing system help make our company a more attractive investment opportunity today.  We also are supported in this endeavor by a talented team with the expertise to execute our new R&D strategy and the experience to optimize our resources quickly.

The decision to prioritize our clinical development activities was a difficult one, but I am encouraged by the determination of my colleagues to advance our company and create sustainable long-term value for all of our stakeholders.  I look forward to reporting on our progress as we begin a new chapter in Aastrom’s remarkable history.


Nick Colangelo