April 4th, 2013
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. Read More…
July 5th, 2012
Dear Friends of Aastrom,
Dilated cardiomyopathy (DCM) is a progressive disease of heart muscle. It is now the third most common cause of heart failure, which affects approximately 4.9 million people in the United States (www.americanheart.org). Dilated cardiomyopathies are associated with both systolic abnormalities (difficulty of the left ventricle to empty or eject blood from its chamber) and diastolic abnormalities (increased resistance to filling of one or both ventricles). The progression of DCM can be rapid; studies have found that 50 percent of the deaths from DCM occur within two years of diagnosis (http://health.usnews.com).
Currently, there is no cure for DCM, but cardiac medications, lifestyle changes and implantable devices can help to control some symptoms. When these treatment options can no longer control symptoms of DCM, heart transplantation may be the only option for many patients – in fact, DCM is now the most frequent cause of heart transplantation (www.americanheart.org). Unfortunately, there are only enough donors for about 2,000 heart transplants each year. More than 95% of patients with moderate or severe heart failure (NYHA Class III or IV) will not be able to get a transplant. (Zacks)
One sign of hope is research showing that mesenchymal cells, monocytes and alternatively activated macrophages can have a positive impact on heart muscle and function damaged by DCM. Read More…