Applied Immune Sciences and Asahi Medical announce treatment of first patient in pivotal device trial.SANTA CLARA Santa Clara, city, Cuba Santa Clara (sän`tä klä`rä), city (1994 est. pop. 217,000), capital of Villa Clara prov., central Cuba. , Calif.--(BUSINESS WIRE)--July 19, 1995--Applied Immune Sciences Inc. (AIS) (NASDAQ/NMS:AISX) and Asahi Medical Co. Ltd., today announced the commencement of a pivotal clinical trial using the AIS CELLector(R) CD5/CD8 device. The trial is being conducted at four clinical sites in Japan under the direction of Professor Shigetaka Asano, a bone marrow transplant bone marrow transplant: see bone marrow. physician at the Institute of Medical Science, University of Tokyo “Todai” redirects here. For the restaurant called Todai, see Todai (restaurant). The University of Tokyo (東京大学 . The Japanese Ministry of Health and Welfare The Ministry of Health and Welfare is a branch of the government of South Korea. External links
• • has announced that this device is designated as an "Orphan Device." This designation enables commercialization of products for patients with rare diseases by offering financial support and priority at examination for regulatory approval. AIS Chairman, Chief Executive and Chief Scientific Officer Dr. Thomas Okarma Dr. Thomas Okarma is the current CEO of Geron Corporation, a biotechnology company. Education Dr. Okarma earned his undergraduate degree from Dartmouth College and his Master's & Ph.D. from Stanford University. Previous Work Dr. , stated, "The AIS CELLector(R) CD5/CD8 is now in advanced human clinical trials in the U.S., Europe and Japan. We are especially pleased that we will receive priority examination of our product in Japan. We anticipate the trial in Japan will take about a year to complete." Asahi Medical Co. Ltd. holds exclusive distribution rights for certain AIS 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. products in Japan. The president of Asahi Medical Co. Ltd., Katsuaki Tsuzuki commented, "Asahi Medical is a leading developer of blood purification devices and systems for treatment of intractable disorders, and currently manufactures and supplies more than 20 advanced products. In the field of bone marrow transplantation, we are conducting research and development activities in cooperation with AIS. One urgent need in this field is an effective method of preventing GvHD. It is our hope that commercialization of the AIS CELLector(R) CD5/CD8 will contribute to the increased success of bone marrow transplantation in Japan." 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 and cancer, autoimmune and infectious diseases. AIS entered into a strategic alliance with Rhone-Poulenc Rorer in 1993 and is now affiliated with 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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