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

A -- SERVICES SOL RFQ80252(NR) DUE 092898 POC Marsha Gorham, Purchasing Agent, (301)402-4509 & Todd Cole, Contracting Officer The Medicine Branch (MB), Division of Clinical Sciences (DCS), National Cancer Institute (NCI) plans to procure the research services of Dr. Hiroaki Mitsuya, 259 Congressional Lane T-2, Rockville, Maryland 20852. The NCI has a Phase I clinical trial of F-ddA, which was initially studied in 1987, underway. NCI has induced F-ddA-resistant HIV-1 variants in vitro and identified mutations conferring on HIV-1 F-ddA-resistance. Furthermore, NCI has generated recombinant HIV-1 carrying such mutations, confirming that those mutations are responsible for the observed ddA resistance. The NCI is now prepared to assess whether such HIV-1 variants emerge in patients during clinical trial. In addition to the foregoing research, the NCI must continue and extend its current study of multi-dideoxynucleoside resistant (MDR) HIV-1 variants during combination chemotherapy. The impact of the emergence of five unique mutations is to be assessed. To date all or a subset of these five mutations have been identified in six of 36 patients (approximately 20%) receiving AZT plus ddC or AZT plus ddl. NCI presently wants to determine whether the emergence of MDR-HIV-1 correlates with clinical deterioration in patients receiving combination chemotherapy. Dr. Mitsuya has been involved in the above studies, and his expertise is needed to perform the final phases. Dr. Mitsuya is the only source known to NCI with the expertise to carry out the final work of these studies that he was previously involved in under another contract. Dr. Mitsuya is a leading expert in studies involving HIV research. In particular, he is an expert in the culture of T-cell clones. He has developed an in vitro drug testing system using normal helper T-cell clones for the cytopathic effect of HIV, which led to the detection of the potent antiviral activity of suramin. Dr. Mitsuya also developed a T-cell clone (ATH8) that was sensitive to the cyotpathic effect of HIV in vitro this was initially the standard line for anti-HIV assays. Dr. Mitsuya also showed that AZT had potent anti-HIV activity in vitro. The above research is just some of the expertise into potential therapies of AIDS that Dr. Mitsuya has been involved with regarding antiretroviral nucleosides. He has also been recently involved in identifying a series of potent HIV protease inhibitors, and he has identified several inhibitors that do not allow HIV to readily develop drug resistance in vitro. Since NCI requires a foremost expert researcher on multi-dideoxynucleoside resistance to HIV variants, anti-HIV activity, and HIV protease inhibitors to finalize the aforementioned studies, Dr. Mitsuya is the only known source who can meet the requirements due to his vast experience and expertise and his involvement with the ongoing Phase I trial and multi-dideoxynucleoside resistant (MDR) HIV-1 variants. If any interested party believes it can perform the above work and has significant experience in the above areas, it may submit a statement of capabilities. 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 1:00 p.m. EST, on September 28, 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 09/10/98 (W-SN248207). (0253)

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