Aastrom Maps Out Pivotal Trial Strategy With Adult Stem Cell Therapy

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shrinking, and they often have different opinions than radiologists who look at the same picture in a central office. Tumor shrinkage itself is really just a “surrogate” measurement that’s supposed to provide a quick read on whether a drug is actually going to help people live longer, the gold standard for success in cancer drugs.

But with critical limb ischemia, patients have essentially run out of options other than amputation. About one-fourth of patients die within the first year of diagnosis, and less than one-fourth of patients survive as long as four years. So a trial that straightforwardly measures survival and amputation rates is practical for a company of Aastrom’s size to run, and will provide hard objective data that will say whether it’s working.

“If your therapy works, you know it, and if it doesn’t work, you know that too,” Mayleben says.

Besides the interactions with the FDA, which will probably take a couple months to nail down, the next big item on Aastrom’s to-do list is an appearance at the VEITH symposium, a meeting of vascular surgeons in New York in November. We’ll keep an eye out for those findings to see if it says anything really new about the Aastrom approach, and offers much confidence on whether it might work in the upcoming Phase III trial.

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