May 6th, 2013
As my colleagues at Aastrom participate in important medical meetings on regenerative medicine and cellular therapy, we can see why 2013 has been named the “Year of the Stem Cell” by The Atlantic magazine. The medical community is excited about the therapeutic potential of regenerative medicine and our unique multicellular product candidate ixmyelocel-T is attracting great interest as a promising new treatment modality for serious cardiovascular diseases such as advanced heart failure due to ischemic dilated cardiomyopathy.
It is well understood that there are multiple cell populations and multiple signaling pathways involved in the disease progression involving tissue injury, chronic inflammation, and the resulting tissue damage that leads to loss of organ function, as well as the processes involved in the repair and regeneration of damaged tissue. Therapeutic approaches targeting single signaling pathways in these complex disease and repair processes have not proven effective, and most cell therapy approaches expand a single cell type to attempt to arrest manifestations of the disease. Aastrom is taking what we believe is a highly differentiated and superior therapeutic approach by developing multicellular therapies that utilize an expanded population of the key cell types that the body naturally uses to repair and regenerate damaged tissue.
Ongoing discovery research by Aastrom scientists and our outside collaborators continues to define the mechanism of action of ixmyelocel-T and differentiate our product from other cell therapies based on the activity of the two key cell populations in ixmyelocel-T: mesenchymal stromal cells (MSCs) and M2-like anti-inflammatory macrophages. These key cells have multiple direct activities and beneficial effects on nearby cells that have been shown to promote tissue repair and regeneration by reducing inflammation and promoting angiogenesis and remodeling of damaged tissue. Based on the activities of these cells and the resulting therapeutic effects, Aastrom’s unique multicellular therapy platform offers the potential for multiple therapeutic applications in treating cardiovascular and other fibrovascular disorders of the lungs, liver, kidney and other organs.
There is enormous therapeutic potential for ixmyelocel-T based on its multicellular composition and the promising results in the treatment of ischemic or damaged tissue demonstrated in preclinical and clinical studies conducted to date. We look forward to generating results in our current ixCELL-DCM phase 2b study of ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy, and continuing to explore the potential therapeutic effects of ixmyelocel-T to repair and regenerate damaged tissue in other severe diseases.
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…
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…
June 4th, 2012
Dear Friends of Aastrom,
Whenever I am asked what makes Aastrom a leader in cell therapy, I usually begin my answer by citing the evidence of our leadership.
During the past year, we have demonstrated the therapeutic potential of our unique product to treat cardiovascular diseases for which there are no other approved therapies. We have validated and expanded our efficient, proprietary, high-margin, state-of-the-art cell-production technology. We have launched the largest and most advanced clinical research program in critical limb ischemia and attracted significant new capital from institutional investors. These achievements reflect the enormous progress we have made to advance our unique cell therapy into late-stage clinical development.
The qualities that make Aastrom a leader take longer to describe but they are no less important to understanding why we have been successful. They include how we work, the values we uphold and the company we keep.
How we work at Aastrom is a reflection of our unique corporate culture and the talented team we have assembled. We are not unique among biotechnology companies simply because we work hard and believe in what we do. We are unique because we have skills and experience unlike any other company and bring unwavering dedication to our mission. As a result, we have identified important unmet medical needs and markets where our technology can best be applied – and we have moved rapidly to address these new opportunities. Read More…
April 24th, 2012
Dear Friends of Aastrom,
Over one million people in the U.S. are living with critical limb ischemia (CLI), a severe form of peripheral arterial disease (PAD). CLI is a devastating and often fatal disease where blood flow to extremities is restricted, resulting in debilitating pain, life-threatening infections, loss of limbs, and death. There are currently no FDA-approved therapies to treat CLI; the most frequent treatment option is revascularization surgery to restore blood flow to affected areas. However, all too often, especially for very ill CLI patients, revascularization surgery is not effective. At Aastrom we are applying our proprietary cell-processing technology to develop an entirely new approach to the treatment of CLI. Read More…
February 6th, 2012
Dear Friends of Aastrom,
The issue of safety associated with stem cell therapies has been in the news recently. Last month, the FDA issued a consumer update describing potential risks associated with the use of stem cell therapies that have not yet been approved. Also recently, 60 Minutes ran a story about patients with severe illnesses who sought treatment with unapproved stem-cell therapies when no approved treatment options were available. In many cases, these patients paid vast sums of money and traveled to other countries to be treated with potentially dangerous and unregulated cell therapies.
These reports highlight the value of appropriate safety standards in the development of cellular therapies, standards which Aastrom maintains in all of its development, manufacturing and shipping procedures. These stories also raise an important issue about the different types of stem cells used in medical research and drug development, and the need to define clearly which cell types are being used. In many cases, the ethical or safety concerns associated with cell therapies relate to the use of embryonic stem cells, not the use of adult or autologous (“patient-specific”) stem cells which we use at Aastrom. Therapies derived from non-embryonic stem cell therapies are now approved for use in treating more than 70 medical conditions. 1, 2
In the development of our cellular-medicine product, Aastrom uses the patient’s own bone marrow, which is collected in an outpatient setting. After the sample arrives at our laboratory in Ann Arbor, each step of the production process is carefully monitored to meet or exceed the safety and quality standards established by the FDA. Read More…