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…
March 9th, 2012
Dear Friends of Aastrom,
The financial turmoil of the past three years has made fundraising especially difficult for capital-intensive biotechnology companies that must rely on investors or partners to fund their operations and keep promising development programs on track. During this period of economic uncertainty, we have seen venture capitalists, institutional investors and pharmaceutical companies shift their risk tolerance in favor of proven technologies (i.e., small molecules and antibodies) and later-stage product candidates. There are also fewer of these investors compared to several years ago, which has made it more difficult for companies with novel technologies and/or earlier-stage programs to raise capital or partner on reasonable terms.
During the past few years, we have seen many biotech companies be forced to raise money by selling their stock at a significant discount and by issuing warrants worth 50 to 100 percent of the stock being purchased. These discounts and warrants are effective in attracting certain investors to fund a company’s operations. However, they are very expensive inducements and, as we have found, often have long-term negative consequences for existing investors. Read More…