By Mary Welch

Aastrom Biosciences Inc. began a Phase III trial to evaluate the use of the AastromReplicell Cell Production System to provide an alternative method of cell collection for cancer patients requiring autologous stem-cell transplants.

Though accrual time for the U.S. trials is expected to be about one year, the company is already planning to launch the device in Europe early next year, said Douglas Armstrong, president and CEO.

"We had a company reorganization that was designed to focus our resources on the pending European launch and start U.S. pivotal trials," he said. "We laid off about 19 persons, and are ready to market the product in Europe and start the U.S. pivotal trials."

Ann Arbor, Mich.-based Aastrom plans to accrue about 80 breast cancer patients at three sites, with another under consideration. Patients will be randomized to receive either a targeted dose of peripheral blood stem cells (PBSCs), collected in multiple apheresis procedures, or stem cells produced with the AastromReplicell System in combination with a low dose of PBSC, collected from a single apheresis procedure.

Endpoints will be the reduction in cell collection and apheresis procedures, and recovery of the patient's blood and immune system function within an equivalent recovery period. Secondary endpoints will be to evaluate the number of days that a patient is at significant risk of infection following the transplant, along with the level of tumor cell contamination produced by the AastromReplicell System process, as compared to cells collected through the standard PBSC apheresis method.

Worldwide Market At Least 40,000 Patients

The European approval was based on "the completed feasibility Phase II/III-type trials but they were not randomized. They had the same patient population and treatment regime, though," Armstrong said. The worldwide market for the targeted indication is between 40,000 and 55,000 women per year.

Results from that earlier multicenter trial, completed under an investigational device exemption from the FDA, showed that patients achieved rapid blood cell and immune system recoveries when treated with a combination of bone marrow cells (produced in the AastromReplicell System) and a low dose of PBSC, collected in a single blood apheresis procedure.

The treatment "appears to provide targeted recovery rates similar to patients treated with traditional large-dose PBSC methods involving multiple blood apheresis collection procedures," Armstrong said.

Stem cell transplants are often used to treat patients with cancer or other diseases who undergo extensive chemotherapy or radiation treatments. Often, a patient's bone marrow and blood and immune system cells are damaged in the process, requiring a stem cell transplant to restore them. The standard procedure is to collect a large number of stem cells through multiple PSC apheresis procedures, each of which last from three to five hours.

"With our system, the collection is potentially less invasive and more reliable in its cell collection," Armstrong said.

Aastrom's stock (NASDAQ:ASTM) closed Wednesday at $2.562, up $0.25. *

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