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…
January 1st, 2013
Dear Friends of Aastrom,
As the new interim chief executive officer of Aastrom Biosciences, I am honored to lead the company as we continue to advance the clinical research programs for our lead product candidate, ixmyelocel-T. I believe we have a unique opportunity to improve the lives of people with severe, chronic cardiovascular diseases with ixmyelocel-T, and am very pleased to have the opportunity to bring my experience building successful pharmaceutical brands to this development program as we begin to formulate plans related to commercialization. Since I joined Aastrom in August as chief commercial officer, I have seen firsthand the potential of our technology to treat these diseases and the dedication of our team to bring this promising therapy to patients who may benefit from it. Read More…
September 5th, 2012
Dear Friends of Aastrom,
Discovering, developing and launching new medicines is a challenging enterprise, often requiring more than a decade of pre-clinical and clinical research and an investment in the tens or hundreds of millions of dollars. And the harsh reality is that only about one in ten drugs that reach clinical stage development eventually win FDA approval. Despite these long odds, the biotechnology industry has continued to flourish, even though many traditional sources of capital, such as venture firms, are shrinking and new sources of capital are needed. What does all this mean for the future of cell therapy and companies like Aastrom that are focusing on promising but complex cell therapies?
Many of the risks inherent in drug discovery and development are magnified in cell therapy because the field is relatively young, the science behind it is still emerging and few cell-therapy products have been approved. However, with each clinical and regulatory success, the therapeutic potential of cell therapy becomes more apparent and investor sentiment improves. As a result of recent progress, interest in regenerative medicine is now growing steadily, the number of cell-therapy clinical studies is increasing and capital is flowing toward a few companies with the most promising and late-stage development programs.
Aastrom has benefited from these trends and emerged as a leader in cell therapy because we have focused on compelling applications of our proprietary technology in terms of medical need, clinical rationale and commercial opportunity. Read More…