Xconomy's Luke Timmerman profiles Ann Arbor, MI-based Aastrom Biosciences, which is planning to enroll 500-600 patients with critical limb ischemia to test a promising treatment approach. Its approach involves withdrawing and incubating a patient's bone marrow cells, then spurring growth of adult stem cells and progenitor cells that promote healing. Once re-infused into the patient, these cell are supposed to foster growth of new blood vessels to improve circulation.
CLI is the most severe form of peripheral artery disease, leading to more than 160,000 major limb amputations per year in the U.S. Approximately 25 percent of patients will die within the six to 12 months following diagnosis, and less than 25 percent of patients survive four years. Earlier this week, Aastrom announced that the FDA had granted fast track designation for the company's critical limb ischemia program. And on Wednesday, Aastrom submitted a special protocol assessment to the FDA that describes its proposed Phase III clinical development program in CLI. If the FDA agrees to the protocols outlined in the SPA, Aastrom expects to initiate the program early next year.
The study is a big step Aastrom, as Xconomy notes, with a market valuation of a little more than $40 million. It will cost about $30,000 to $35,000 per patient to conduct the study, and the total budget will run between $15 million and $20 million, says Tim Mayleben, who became the company's CEO last year thanks in part to his "fundraising proficiency," AnnArbor.com reported last year. Mayleben was part of the first version of Esperion--which was eventually sold to Pfizer in 2004--in the late 1990s, eventually becoming chief financial officer and chief operating officer.
After a rough patch over the past couple of years, the company seems to be on the way up. In an interview with MedCity News earlier this year, Mayleben said the biggest hurdle for his company is that a lot of people in the industry think stem cell therapies are many years away from being commercialized. "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."
At least one recent effort to the combat CLI came up short. Last month, Sanofi-Aventis's high hopes for an experimental therapy to treat CLI were dashed by its failure in a Phase III test. However, data showed that hte drug, NV1FGF, was no better than a placebo.
- read Aastrom's release
- get more from Xconomy