Posted on August 1st, 2012 in Aastrom progress
Dear Friends of Aastrom,
As investors and the media continue to follow the progress of stem cell therapy companies, the need for clarity and transparency about our work is growing. We welcome this trend and the responsibility it places on us to describe clearly, openly and on a regular basis what we do.
Over the past year, we have found that investors, clinicians, patients and advocates are most interested in our answers to three key questions:
1. Why do you believe Aastrom’s stem cell therapy will work more effectively than other methods of treating disease?
2. What makes critical limb ischemia (CLI) an appropriate target for Aastrom’s stem cell therapy?
3. When will a large pharmaceutical company embrace stem cell therapy and partner with Aastrom?
The answer to the first question is that bone marrow cells have been used safely and effectively for over 30 years to fight certain diseases. Our stem cell therapy is produced from each patient’s bone marrow. Certain cell types found in and expanded from bone marrow – especially the CD90+ mesenchymal stromal cells and the CD14+auto+ M2 macrophages that comprise the majority of our stem cell therapy – have been shown to support tissue remodeling, address chronic inflammation and promote angiogenesis. No other stem cell therapy has this unique combination of cells. Based on compelling preclinical and clinical results, we believe that delivering our stem cell therapy directly to damaged tissue has therapeutic effects for CLI patients that are not possible with other treatment methods such as open surgical procedures, endovascular devices or traditional pharmaceuticals. Our clinical results thus far provide strong support for this conclusion.
The answer to the second question is that many CLI patients have no other treatment options today. Despite the very best efforts of dedicated physicians and other healthcare providers, 25% of CLI patients die within one year of diagnosis and up to 40% suffer a major amputation of their leg. Traditional medicine is, unfortunately, failing these patients and the medical need is very high. However, stem cell therapies, especially those which use multiple cell types like ixmyelocel-T, appear to address the chronic inflammation, tissue remodeling and angiogenesis needs of these very sick patients. These are the key attributes that play a role in the treatment of CLI patients, who suffer from the most serious form of peripheral artery disease (PAD). Our clinical findings to date suggest that treatment with ixmyelocel-T can reduce the risk of tissue damage, major amputation and death in patients with CLI.
The answer to the third question is that a number of pharmaceutical companies are interested in our technology and clinical progress – but we cannot predict whether or when one of them will decide to work with us. Stem cell therapy, or regenerative medicine, is still a relatively new treatment modality that needs to be proven in well-controlled clinical studies. Partly for this reason, we have worked extensively with clinicians and regulators to develop our REVIVE Phase 3 CLI study, secured a special protocol assessment (SPA) from the FDA and established an independent steering committee, led by Dr. William Hiatt at CPC, to help guide this program, which is the largest ever conducted in CLI. Potential partners have been impressed with our rigorous preparations and we know that through our successful execution of the Phase 3 REVIVE-CLI trial, we will obtain a definitive answer regarding the efficacy and safety of ixmyelocel-T in the treatment of this disease.
These are not the only questions we are asked, but they are probably the most important ones we try to address regularly. Obviously, our answers in the future will depend upon our clinical findings and the decisions we make about Aastrom’s clinical and commercial strategies. In the meantime, we are continuing to advance ixmyelocel-T, educate the financial and medical communities about our work and uphold the values of scientific rigor, accountability, integrity and transparency that are the hallmarks of our company.