Contracts Management Section, National Institute of Dental and Craniofacial Research, NIH, Natcher Building, Room 4AN-44D, 45 Center Drive MSC 6402, Bethesda, Maryland 20892-6402

A -- GENE THERAPY FOR CHRONIC CANCER AND ARTHRITIC PAIN SOL NIH-NIDCR-5-99-8 DUE 070199 POC Marion Blevins, 301 594-0652 The National Institute of Dental and Craniofacial Research intends to negotiate a contract on a sole-source basis with the Institute for Human Gene Therapy (IHGT) at the University of Pennsylvania to construct an adenovirus (AV) or adeno-associated virus (AAV) vector which contains the beta-endorphin expression cassette under GMP conditions, generation of high-titre virus for both adenovirus and AAV, purification steps, and quality control procedures to produce a virus that satisfies FDA requirements for administration to humans. The quantity of the viral vector must be sufficient to conduct all required preclinical toxicology testing and, eventually, proposed clinical trials. IHGT is the only known source with the expertise, data, laboratory facilities, and equipment necessary to perform the effort expeditiously. It is one of few facilities available in the U.S. for manufacturing the vector, fully capable of conducting the preclinical in vivo toxicology testing, and with the demonstrated experience ininteracting with the FDA to prepare successful IND applications for human gene therapy studies. This notice of intent is not a request for competitive offers. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered for the sole purpose of determining whether to conduct a competitive prcurement. The statutory authority is 41 USC 253(c)(1), as set forth in FAR 6.302-1. See Note 22. Posted 05/19/99 (W-SN333340). (0139)

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