[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Notices]
[Pages 63852-63853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


National Institute of Environmental Health Sciences: Opportunity 
for a Cooperative Research and Development Agreement (CRADA) and 
License for the Development of KAI1 in Gene Therapy Protocols for the 
Treatment of Metastatic Disease

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: 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 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.

DATES: Capability statements must be received by NIH on or before 
January 31, 1997.

ADDRESSES: 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 [email protected]

    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: [email protected]
    The NIEHS has applied 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: [email protected]

SUPPLEMENTARY INFORMATION: The National Institute of Environmental 
Health Sciences 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.


[[Page 63853]]


    Dated: November 21, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-30539 Filed 11-29-96; 8:45 am]
BILLING CODE 4140-01-M