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CAREMARK AND AIS' CELLector-AIDS CELL THERAPY CENTERS

Executive Summary

CAREMARK AND AIS' CELLector-AIDS CELL THERAPY CENTERS will be established in six major U.S. cities in an initial phase of a joint venture. The facilities will be built around Applied Immune Sciences' experimental CELLector-AIDS system, an ex vivo system designed to treat HIV and AIDS-related opportunistic infections with funding from Baxter's Caremark division. The companies plan to establish a pilot center in San Francisco in the first half of 1992, and add centers in New York City, Miami, Los Angeles, Washington D.C. and Philadelphia when the treatment receives FDA approval. Eventually, the firms hope to set up facilities in a "large number" of U.S. cities. Under the agreement, blood samples of HIV positive and AIDS patients will be obtained from patients at outpatient facilities run by Caremark. The samples will be sent to the cell therapy center for treatment and then returned to the outpatient facility to be reinfused into the patient. The centers will also treat samples delivered from hospitals, as well as outpatient facilities that are not run by Caremark. CELLector devices employ polystyrene plates coated with monoclonal antibodies that remove targeted cells from blood or other samples. The captured cells are then either discarded or manipulated and reinfused into the patient. In the case of the CELLector-AIDS device, the targeted cells are cytotoxic "killer" T-cells (CD8 cells). Once captured, the CD8 are multiplied and "primed" with cytokine receptors to make them more responsive to interleukin-2 and then reinfused into the patient, who receives simultaneous administration of I.V. IL-2. The San Francisco center will serve as one of several sites for Phase II clinicals of the CELLector-AIDS. AIS expects to submit a protocol for the study to FDA early in 1992. AIS recently reported results from an 11-patient Phase I clinical study at two centers that showed responses to the same treatment among both symptomatic and nonsymptomatic HIV-positive patients. At the Dec. 3 meeting of the AIDS Clinical Trial Group in Washington, D.C., AIS President and CEO Thomas Okarma said that two of the patients in the protocol from the University of Pittsburgh test site "who had gastrointestinal disease symptoms at the onset of study showed resolution of these symptoms, and one exhibited a stable [20 lb] weight gain." The three symptomatic HIV patients in the protocol at the University of Miami trial site "showed a response to the cell infusions" with partial or complete resolution of their Kaposi's sarcoma lesions and other symptoms, Okarma reported. Baxter and AIS also plan to use the therapy centers as locations from which they can introduce other AIS CELLector products to the market, such as the CELLector-TIL for cancer patients and the CELLector-T Cell for bone marrow transplant recipients. Both products are currently undergoing Phase I clinical studies. The Baxter/AIS joint venture expands on the existing distribution relationship between the two firms. The companies currently are renegotiating the distribution pact, which is scheduled to expire in August 1992. AIS also recently sealed an agreement with Asahi Medical, a subsidiary of Tokyo-based Asahi Chemical Industry Company, which grants the Japanese firm distribution rights to the CELLector product line in the Pacific Rim.

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