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Executive Summary

Syntex will begin studies of Immunex' interleukin-1 as a chemoprotectant "within the next few weeks," Immunex Chairman Stephan Duzan noted at a recent biotechnology conference in San Francisco sponsored by the Cowen & Company investment firm. The Phase I trials are planned for two centers, the National Cancer Institute and Memorial Sloan-Kettering, and will include up to 20 patients at each site, according to Immunex. Syntex, which filed its IND application in August, also plans to eventually study IL-1 as a treatment for rheumatoid arthritis. Meanwhile, Immunex is hoping to begin clinical evaluation of IL-1 both as a topical agent in wound/burn healing and as a vaccine adjuvant by the end of this year. The efforts represent the first for Immunex in developing a product independently. Duzan reported that advanced clinical development of granulocyte macrophage colony stimulating factor (GM-CSF) is continuing both in patients with bone marrow transplants and those with neutropenia resulting from chemotherapy. Phase III studies are in progress at the Fred Hutchinson Cancer Center in Seattle and at the University of Nebraska Medical Center. GM-CSF is also being studied as an immune booster in AIDS patients. Immunex, which is managing all U.S. clinical trials, is collaborating with Hoechst subsidiary Behringwerke on the development of six CSFs. Immunex will likely expand its GM-CSF clinical development program in 1988 to include a study of the white blood cell growth factor in AIDS patients as part of a combination therapeutic regimen, Duzan added. Two other white cell growth factors, G-CSF and interleukin-3, could be ready for human clinicals either by year end or the first quarter of 1989, according to Duzan. The exec also reported on the product furthest along in the Immunex pipeline, interleukin-2, which is being developed by Roche. The last patients to be covered under Roche's Product Licensing Application (PLA) have been enrolled, Duzan said, with data expected to be available in the fourth quarter. Roche plans to file its PLA for IL-2 as soon as possible thereafter. Duzan said that while Roche has not announced the indications that will be covered by its PLA, the best responses of IL-2 have been observed in melanoma and renal cell carcinoma. Through Immunology Ventures, joint venture partner Kodak is conducting Phase I studies of interleukin-4 at M.D. Anderson in patients with a variety of refractory cancers. In preclinical trials, the lymphokine product has shown an ability to stimulate the production of B-cells and T-cells. Duzan reported that studies of IL-4 are expected to begin "at several more sites" during the fourth quarter. The increased development activity during 1988 has resulted in a corresponding need to manufacture sufficient quantities of materials for clinical trials. As part of the May restructuring of its joint venture agreement, Immunex purchased Kodak's share of the Immunology Ventures pilot manufacturing facility. The plant, which opened in June, has orders that will keep it operating at full capacity through the end of 1988, Duzan said. In addition, Immunex is in the process of completing a feasibility study for a $ 7 mil. full-scale facility, which could be operating as early as 1991. A separate subsidiary, Immunex Manufacturing Corp., has been created to handle that function, complementing the activities of the company's development arm, Immunex R&D Corp.

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