Activated Cell Therapy Receives 510k Allowance from FDA; for Company's Cell Separation Technology.MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aug. 20, 1996-- Activated Cell Therapy, Inc. (ACT) announced today that the Food and Drug Administration has granted marketing allowance to the company's 510(k) application for its patented cell processing devices used for cell isolation and enrichment. "This technology allows the efficient recovery and preparation of important cells, such as stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young and dendritic cells, from peripheral blood peripheral blood Cardiology Blood circulating in the system/body , bone marrow or cord blood cord blood n. Blood present in the umbilical vessels at the time of delivery. ," said David Urdal, Ph.D., chief scientific and operations officer at ACT. "Unlike most other approaches to cell selection, our devices can be used in standard laboratory equipment, are sterile, and manufactured according to Good Manufacturing Practices." The company anticipates that the use of these devices will significantly simplify the preparation of cells. "With the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. allowance of the 510(k), ACT will focus on completing a number of clinical trials which are underway in the field of cell therapy," said Frank H. Valone, M.D., vice president of medical and regulatory affairs. ACT is currently sponsoring clinical studies involving stem cells from bone marrow and human peripheral blood for treating patients with breast cancer, leukemia and lymphoma. In recent years, stem cell transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. in conjunction with high dose chemotherapy has become an accepted treatment for certain cancers such as leukemia and non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma and is becoming widely accepted in the treatment of breast cancer. Also underway at ACT are clinical programs for the treatment of prostate cancer and lymphoma which couple the company's cell separation capability with its proprietary dendritic cell technologies. ACT's immunotherapy strategy is to direct the immune system to specifically attack and eradicate the cancerous cells. Success with this approach in the treatment of B cell lymphoma was recently reported in Nature Medicine. Activated Cell Therapy is a leader in the development of cell therapies for the treatment of cancer and infectious disease. It is a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. founded in 1992. CONTACT: Activated Cell Therapy, Inc. Richard Bastiani Ph.D., 415/964-6744 or J. Kureczka Associates Joan E. Kureczka, 415/821-2413 |
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