Published in the Federal Register, December 2, 1996, pp 63852-63853 [61 FR 63852].
CRADA Opportunity for the Development of KAI1 in Gene Therapy Protocols for the Treatment of Metastatic Disease
The National Institutes of Health (NIH) seeks a company(ies) to pursue the development of gene therapy protocols involving the KAI1 metastasis suppressor gene. The National Institute of Environmental Health Sciences (NIEHS) has established that KAI1 alterations occur in the development of malignant prostate cancer, and that its loss is correlated with progression to the metastatic phenotype.
The NIEHS has shown that the KAI1 gene can suppress metastasis of prostate cancer and is down regulated in human malignant prostate cancers. Therefore it is possible that treatment of patients who are diagnosed with prostate cancer in the early stages may be treated with the KAI1 gene, to prevent the metastasis of their tumors, in conjunction with other therapies that are used to eradicate the primary tumor. It has been shown that expression of KAI1 in normal cells is not toxic and does not affect cell growth.
The NIEHS of the NIH is seeking capability statements from interested parties in developing a CRADA to develop gene therapy vectors as well as to develop models in which to test the efficacy of the use of KAI1 in gene therapy. This project is with the Laboratory of Molecular Carcinogenesis, Cancer and Aging Group at the National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina. The goals are to use the respective strengths of both parties to achieve one or more of the following:
1. Develop suitable gene therapy vectors containing the KAI1 gene.
2. Develop a model for testing the efficacy of KAI1 vectors for the suppression of tumor metastasis in vivo, including gene delivery and metastases assays, and assessment of toxicity of treatment protocol.
It is anticipated that under this CRADA, the NIEHS will (1) provide cDNA of KAI1 gene for insertion into appropriate vectors and (2) work cooperatively with interested company(ies) to develop and test a model that is suitable to measure the ability of KAI1 to suppress tumor metastasis in vivo. The collaborator may also be expected to contribute financial support under this CRADA for supplies and personnel to support these projects.
Selection criteria for choosing the CRADA partner(s) will include, but not be limited to the following:
1. Experience in the development of gene therapy vectors.
2. Experience in delivery of pharmacological agents in vivo.
3. Ability to develop appropriate animal model for testing.
Capability statements must be received by NIH on or before January 31, 1997.
Proposals and scientific questions about this opportunity may be addressed to Dr. J. Carl Barrett, NIEHS, Mail Drop C2-15, P.O. Box 12233, Research Triangle Park, NC 27709. Telephone (919) 541-2992; Fax (919) 541-7784; E-mail Barrett@NIEHS.NIH.GOV.
Questions related to the CRADA process may be addressed to Ms. Lili Portilla, Senior Technology Transfer Specialist, National Heart, Lung, and Blood Institute, 31 Center Drive MSC 2490, Building 31, Room 1B30, Bethesda, MD 20892-2490; Phone: (301) 402-5579; Fax: (301) 594-3080; E-mail: portilllmd for patents claiming this core technology. Non-exclusive and/or exclusive licenses for these patents covering core aspects of this project are available to interested parties. Licensing applications and licensing inquiries regarding this technology should be referred to Mr. Ken Hemby, Technology Licensing Specialist, NIH Office of Technology Transfer, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; Phone: (301) 496-7735 ext 265; Fax: (301) 402-0220; E-mail: HembyJ@6100M1.odnih.gov.