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Dendreon Receives Premarket Approval from the FDA for its Stem Cell Separation Device.

SEATTLE--(BW HealthWire)--Aug. 10, 1999--

Dendreon Corporation today announced that it has received approval from the U.S. Food and Drug Administration to market its DACS(TM)SC -- a proprietary device used to prepare autologous hematopoietic stem cells from blood.

The DACS(tm)SC is used for the isolation of these cells, also called peripheral blood progenitor cells, for transplantation in cancer patients following high dose chemotherapy or radiation therapy. Stem cells are used to reconstitute the blood and immune system. The Dendreon device has been tested in clinical trials at four major medical centers.

"We are extremely pleased by the approval," said David Urdal, Ph.D., Chief Scientific Officer of Dendreon. "It is our first premarket approval, and the clinical results described demonstrate that stem cells can be effectively processed in our device and are then safe and effective for immune reconstitution. The approval bodes well for the other cell therapy products we have under development."

The DACS(tm)SC works by layering white blood cells over a specially formulated buoyant density solution in a patented two-chambered separation container. Following centrifugation, cells separate based upon their relative buoyant densities -- stem cells are found at the interface in the upper chamber, while cells with higher density are trapped in the bottom chamber of the container. The DACS(tm)SC is designed to accommodate the processing of up to 50 billion white blood cells in a single sterile, disposable and closed device.

Dendreon also uses other configurations of the cell separation technology, which is at the core of the DACS(tm) technology, to isolate and enrich dendritic cells for its clinical studies of dendritic cell therapy for prostate cancer and multiple myeloma.

Dendreon Corporation is a private biotechnology company developing cell-based therapies for the treatment of cancer and infectious diseases. Central to its research approach is the use of dendritic cells to stimulate immune responses. Dendreon was founded in 1992 and is headquartered in Seattle, Wash. For more information about the company, visit www.dendreon.com.
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Publication:Business Wire
Date:Aug 10, 1999
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