The most promising application of Athersys Inc.’s (NSDQ:ATHX) stem cell technology lies in treating stroke victims, according to a Morningstar Inc. analyst.
“It’s really market potential that leads us to believe that stroke is the most promising indication,” said Lauren Migliore, an equity analyst who covers several medical companies for Chicago-based Morningstar.
That’s largely due to the size of the potential ischemic stroke market for MultiStem, an off-the-shelf stem cell treatment derived from bone marrow or other non-embryonic sources. Athersys estimates the market for MultiStem’s stroke application to be in the billions of dollars, a company spokesman said. The estimated direct and indirect cost of stroke in the United States reached nearly $70 billion last year, according to the American Heart Association (PDF).
More than 700,000 patients suffer from ischemic stroke each year in the United States, but just 5 percent are treated with the only clot-busting drug approved by the Food and Drug Administration, Migliore said. The drug is called tissue plasminogen activator, or "t-PA," and is marketed as Activase by Genentech.
The problem with t-PA is that it’s approved for treatment only during the first three hours after stroke symptoms begin. MultiStem, in contrast, has shown promise in preclinical studies to help animals with surgery-induced strokes for up to a week after symptoms appear, potentially representing a huge advantage over t-PA, not to mention a much bigger market for Athersys.
That makes Athersys’ shares potentially attractive to investors, but it’ll likely be a long time before the company’s promise bears much fruit. Migliore estimated that the company won’t get a MultiStem product on the market before 2015, and even then, it may not be the stroke treatment. Athersys is investigating MultiStem for several other applications, including heart attacks and inflammatory bowel disease.
Further, MultiStem hasn’t been tested yet in human stroke victims. Although Athersys was authorized in December 2008 by the FDA to begin a Phase 1 clinical trial of MultiStem for stroke victims, it has yet to begin the study. The company plans to initiate the trial next year, a spokesman said.
With about $18 million on its balance sheet, Athersys has enough cash to last about a year, Migliore said. However, that shouldn’t be a cause for concern because the company is likely to sign more commercialization and development deals that bring in revenue, like the ones it’s inked with RTI Biologics and Pfizer.