Applied Immune Sciences Announces Start of Phase III Cell Therapy Trial in Renal Cell Carcinoma.SANTA CLARA, Calif.--(BUSINESS WIRE)--Dec. 15, 1994--Applied Immune Sciences Inc. (AIS) (NASDAQ/NMS:AISX) Thursday announced that it has opened enrollment for a Phase II trial using activated and numerically expanded immune cells to treat advanced kidney cancer Kidney Cancer Definition Kidney cancer is a disease in which the cells in certain tissues of the kidney start to grow uncontrollably and form tumors. . This randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial will compare the use of activated immune cells together with low dose IL-2 against low dose IL-2 alone in patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. kidney cancer. Patients' cells will be processed at the cell processing center in Torrance, Calif., constructed and operated by ExVT, a joint venture of AIS and Rhone-Poulenc Rorer. The AIS CELLector-CD8 device will isolate specific CD8+ Tumor Infiltrating Lymphocytes (TIL) that will then be activated with IL-2, numerically expanded, and returned to the physician for reinfusion to the patient. The ExVT Cell Processing Center is a commercial scale facility that operates under current good manufacturing practices (cGMP) guidelines. A Phase I/II trial using a similar protocol was conducted by Drs. Belldegrun and Figlin of the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). Medical Center in Los Angeles. Results of that trial showed a 44% response rate. Other commercially available biological or chemotherapies for metastatic kidney cancer have shown overall response rates of up to 15%. According to Dr. Thomas Okarma, AIS chairman, chief executive and chief scientific officer, "We believe we are one of the first companies to conduct a Phase III trial that involves complex ex-vivo processing of cells rather than simple isolation and reinfusion. Our experience in preparation of over 200 samples at our pilot cell processing center in South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. has formed the basis for the design of the ExVT Cell Processing Center in Torrance, Calif., and we believe has made it possible for AIS to achieve validated facility, equipment, processes, and assay standards that meet cGMP guidelines. Similarly, we believe that our attention to detail will provide an element of safety and quality to cell therapy that will be required to demonstrate its medical value." Applied Immune Sciences develops, manufactures and delivers innovative cell and gene therapy products designed to enhance and restore the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. in immune-related conditions such as bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. and autoimmune, infectious and malignant diseases. AIS entered into a strategic alliance with Rhone-Poulenc Rorer in 1993 and is now part of the newly formed RPR (Resilient Packet Ring) A packet-based protocol that provides fault tolerance and statistical multiplexing for the metropolitan and national SONET and Ethernet networks of the carriers. division, RPR Gencell. Through RPR Gencell, AIS has access to a network of 14 commercial, academic and other institutions in the biotechnology field. AIS products are now in human clinical trials for bone marrow transplantation and the treatment of AIDS and cancer. CONTACT: Applied Immune Sciences Inc. Jackie Cossmon, 408/492-9200 |
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