National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

A -- SERVICES SOL RFQ80230 (NR) DUE 092298 POC Marsha Gorham, Purchasing Agent, (301)402-4509 & Todd Cole, Contracting Officer The Laboratory of Molecular Biology (LMB), Division of Basic Sciences (DBS), National Cancer Institute (NCI) plans to procure the services of the John Wayne Cancer Center, 2200 Santa Monica Boulevard, Santa Monica, California 90404. The Laboratory of Molecular Biology has been engaged in designing, producing, and testing new drugs to treat cancer. These drugs are genetically modified forms of Pseudomonas Exotoxin A that are targeted to cancer cells. The preclinical development of IL-4-PE38 was done in the LMB and at the Food and Drug Administration. It was shown that glioblastomas express IL-4 receptors. The fusion protein, IL-4-PE38 caused regression of the IL-4 receptor expressing tumor cells in mice. It was also shown that IL-4-PE38 could be given intravenously in mice and monkeys and into the brains of rats and monkeys. Specific studies indicated that IL-4PE38 may be useful therapy of glioblastomas. John Wayne Cancer Center, through the Food and Drug Administration, is currently involved in the treatment of glioblastoma and astrocytoma patients using IL-4-PE38. John Wayne Cancer Center's IRB approved Phase I trial, under FDA approval BB-IND-7004, is using a clinical grade drug of IL-4-PE38. Because the National Cancer Institute was involved with the development of the clinical compound for the aforementioned drug, it is necessary to receive the compiled data and results from the trials at John Wayne Cancer Center to ascertain its usefulness in treating cancer. Since the John Wayne Cancer Center is the only organization with an approved Phase I trial approval by FDA, it is the only source known to NCI that can meet the requirements of providing the compiled subject data to the NCI. If any interested party believes it can perform the above work and can demonstrate that it has an ongoing Phase I trial approved by the FDA using a clinical grade drug of IL-4-PE38, it may submit a statement of capabilities, including evidence of FDA approval. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 3:00 p.m. EST, on September 22, 1998. If you have any questions, please contact Marsha Gorham, Purchasing Agent on (301) 402-4509. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Posted 09/03/98 (W-SN245509). (0246)

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