Aastrom Biosciences Inc has completed all requirements to affix the CE Mark on its DCV-II kit in the European Union. This is the third of the Company's dendritic cell production kits to use the CE Mark. The DCV-II kit operates on the AastromReplicell System instrument platform, and produces peptide-loaded dendritic cells that are being investigated in clinical trials as therapeutic cancer vaccines. The CE Mark allows Aastrom to market and sell DCV-II kits in Europe; the kits are available as well in the United States for clinical research use.
Dendritic cells loaded with specific tumor-associated fragments called peptides are one of the new approaches currently being clinically investigated to induce a therapeutic immune response to different forms of cancer. These tumor-associated peptides include melanoma, colon, breast and prostate cancer-associated peptides. The AastromReplicell System and the DCV-II vaccine production kits facilitate such studies by allowing researchers and investigators to produce sufficient clinical quantities of dendritic cells in an automated, closed-system, Good Manufacturing Practices (GMP)-compliant process. In addition, like the previously released DC-I and DCV-I kits, the DCV-II kit offers clinical investigators the ability to produce dendritic cells loaded with a broad array of tumor antigens, and are intended to bring forward a variety of vaccines based on Aastrom's technology.
Other CE Marked Aastrom products include: the AastromReplicell System (System), the DC-I kit, intended for the production of dendritic cells for use in fusion or transfection cell-based cancer vaccines and the DCV-I kit, intended for the production of complete antigen-loaded dendritic cell vaccines. Aastrom has installed the System for several of its products in fifteen sites in Europe and the United States; sites evaluating the Company's dendritic cell production products include: Stanford University and Duke University in the United States, and University of Mannheim and University of Erlangen in Germany.
The Company markets and sells its Cell Production Products in Europe through its wholly owned subsidiary, Zellera AG.