Tim Mayleben had a front-row seat as a board member to the shaky period two years ago when stem cell company Aastrom Biosciences was clinging to survival. Now, he’s in the driver’s seat as things are looking up for the publicly traded biotech firm.
In 2012, Aastrom (Nasdaq: ASTM) could launch its first product–a treatment that involves injecting patients with their own bone marrow stem cells to treat a serious vascular disease that can lead to limb amputation. Aastrom is looking to start a Phase 3 clinical trial of its vascular repair technology next year for the condition, called critical limb ischemia. But a short time ago, it looked doubtful whether the company could even make it to the point where late-stage clinical trials were in sight.
In April 2008, the company failed to get shareholder backing for a reverse stock split that it deemed “vital to the future of the company.” After that failure, the company acknowledged its future was in doubt and it was in danger of being de-listed from the Nasdaq Stock Market.
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But in just the last few months, Aastrom completed the critical reverse stock split and returned to Nasdaq’s good graces. In addition to its vascular repair work, Aastrom is in the midst of a Phase 2 trial investigating its technology in repairing heart cells. In that trial, Aastrom is treating patients suffering from dilated cardiomyopathy, a severe form of congestive heart failure in which the heart becomes weakened and enlarged, and cannot pump blood efficiently.
Mayleben, who’s sat on Aastrom’s board since 2005, took over as chief executive in December. He spoke with MedCity News about how the company”s technology works and what he learned watching up close as Aastrom teetered on the brink of collapse.
Q: Talk a little bit about exactly how Aastrom’s technology works.
A: We call our development platform tissue repair cell technology or TRCs. We start with a small amount of bone marrow, about 3 tablespoons, that’s taken from a patient’s hip and done in a 15-minute outpatient procedure. That sample of marrow contains cells known to play a role in the natural healing process. We then put those cells into our proprietary cell processing system and we significantly expand the population of mixed stem and progenitor cells that support the regeneration of tissue.
That process takes about 10 to 12 days. When it’s done, we have a rich and diverse population of early stem and progenitor cells that promote the healing of vascular and cardiac tissues. It’s important to note that we work with adult stem cells derived from patients, so we don’t have any of the ethical issues involved with the use of embryonic stem cells, or issues with rejection.
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Q: What’s the biggest challenge facing Aastrom right now?
A: The biggest challenge for Aastrom is that a lot of people in the life sciences industry think stem cell therapies are many years away from being commercialized. At Aastrom, we don’t think we’re that far away. We’ve enrolled the last patients in both our Phase 2b study of critical limb ischemia and another study of dilated cardiomyopathy. We’ll report our six-month results this year and plan to start a Phase 3 in 2011. That’s the last step before FDA [Food and Drug Administration] review and approval.
We can’t predict exactly when our products will be on the market because the FDA has final say in when things will be approved. Meantime, we can say we’re moving full-steam ahead in developing our products.
Q: Why was it important to continue being listed on Nasdaq?
A: One of the things I’ve learned from being at public companies is that when you’re public, you can attract far greater institutional ownership of your shares. That’s really important for us to continue to get recognized. You’re exposed to a much broader population of investors. That leaves us really well positioned to execute on our clinical development programs and transition to commercialization.
Q: Having served on Aastrom’s board in 2008 when the company’s future was in question, what’s the most important thing you learned from that experience that you bring to your role as CEO?
A: In my experience, most biotech companies go through one or more of those difficult periods. The most important thing we keep in mind is the patients who will be helped by our therapy. Our focus is on improving the lives of critical limb ischemia and dilated cardiomyopathy patients who have no other treatment options for their disease. We have to get through the tough times and the good times, so we just focus on the patients.
