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Executive Summary

IMMUNEX/SYNTEX INTERLEUKIN-1 CLINICALS FOR RADIOPROTECTIVE USES will be conducted, Steven Gillis, Immunex executive vice president and director of R&D, disclosed at a security analysts meeting in Chicago Oct. 16. Interleukin-1 (IL-1) is currently being studied for radioprotection in preclinical trials. "IL-1 is capable of reducing radiation induced bone marrow failure and promoting survival," Gillis stated. Immunex has various arrangements with Syntex for the development of IL-1. Presenting the results of the IL-1 preclinical studies, Gillis stated that "administration of IL-1 to mice 20 hours before subjecting them to lethal dose irradiation has caused approximately 85-90% survival." These results have important implications for cancer therapy, Gillis said, because "it is conceivable that cancer patients could be treated with higher doses of radiation to produce greater anti-tumor effects, provided that those same patients were first treated with IL-1 to counteract the effects of radiation on their bone marrow." IL-1 is also in preclinical testing as a vaccine adjuvant and will move into human clinicals in the first half of next year. "The market for an FDA approved adjuvant could be extremely large, with existing human and economic animal vaccines being reformulated to an adjuvant-containing product," Gillis remarked. Immunex chose the adjuvant application of IL-1 for its own development. Immunex has arranged with Syntex to independently commericalize the wound and burn healing applications of IL-1. "We're conducting animal trials to confirm IL-1's in vitro actions on skin cell proliferation. If these tests are positive, we hope to begin human testing next year," reported Gillis. Immunex and Syntex are studying the prevention of IL-beta effects such as bone demineralization and rheumatoid arthritis. Phase II clinicals of interleukin-2 (IL-2) for cancer treatment are being conducted by Immunex' partner, Hoffmann-LaRoche. "The U.S. market for IL-2 has been estimated by analysts and independent market studies at over $400 mil., with many thousands of patients potentially treatable," Gillis noted. Immunex expects a 1988 market entry for IL-2. Immunex' IL-2 receptor antibody has just entered Phase I clinicals as a treatment for preventing rejection in bone marrow transplant patients, Gillis noted. The antibody will be tested in additional trials for its capability to prevent rejection of organ transplants. The antibody has been licensed to Becton Dickinson, which will conduct clinical trials. Human clinical trials will begin later this year for granulocyte-macrophage (GM-CSF), which stimulates white blood cells to kill tumor cells. GM-CSF will be tested as a treatment for cancer and infectious disease. The clinicals will test its ability to help in transplantation of bone marrow in acute leukemia and lymphoma and its ability to generate white blood cells in cancer patients after radiation and chemotherapy. GM-CSF development is a combined effort between Immunex and Behringwerke, a subsidiary of Hoechst AG. Gillis also added that Immunex is investigating a cure for the common cold which involves "neutralizing the effects" of rhinoviruses, the organisms that cause the common cold. "It is our first significant venture outside of immunology," Gillis said. Immunex is a Seattle-based biotechnology company that develops immunological therapeutic products that modulate or control immune responses. Immunex' long term goal is to become a full integrated pharmaceutical company. "Immunex in 1986 is in the best financial condition of its history with revenues up over 166% compared to the first half of 1985," said Immunex President Stephen A. Duzan at the meeting.

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