[Federal Register Volume 60, Number 139 (Thursday, July 20, 1995)]
[Notices]
[Pages 37455-37456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17779]



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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) for 
Development of Antibodies to the Cancer Metastasis Suppressor Gene KAI1

AGENCY: National Institute of Environmental Health Sciences, National 
Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) seeks an agreement 
with a company(s) which can pursue commercial development of antibodies 
to the KAI1, a cancer metastasis suppressor gene (U.S. Patent 
Application Serial No. 08/430,225). The National Institute of 
Environmental Health Sciences has also determined that antibodies to 
this gene can be used in diagnosis of malignant cancers of the prostate 
and other tissues. A CRADA for the co-development of diagnostic 
antibodies will be granted to the awardee(s).

ADDRESSES: Proposals and questions about this opportunity may be 
addressed to Dr. J. Carl Barrett, NIEHS, Mail Drop C2-15, PO Box 12233, 
Research Triangle Park, NC 27709. Telephone (919) 541-2992; Fax (919) 
541-7784; E-mail [email protected].

DATE: Capability statements must be received by NIH on or before 
September 18, 1995.

SUPPLEMENTARY INFORMATION: The National Institute of Environmental 
Health Sciences has shown that the KAI1 gene can suppress metastasis of 
prostate cancer and is downregulated in human malignant prostate 
cancers. Therefore, it may be of use in distinguishing prostate cancers 
that will progress and be lethal from nonfatal cancers. The role of 
this gene in other cancers is currently under investigation. This 
protein is a transmembrane protein. Antibodies to the extracellular 
domain of the protein should detect its expression in tissue sections 
and tumor biopsies and be used in cancer diagnosis and prognosis.
    The CRADA is for the development of antibodies to this protein and 
the development of cancer diagnostic tests. 

[[Page 37456]]
The awardee will have an option to negotiate an exclusive license to 
market and commercialize any new antibodies and tests developed within 
the scope of the research plan.

Role of the NIEHS

    1. Provide expression vectors and recombinant protein as antigen 
for antibody production.
    2. Work cooperatively with the company(s) to test antibodies 
produced for their ability to detect the KAI1 protein and determine its 
utility in cancer prognosis.

Role of the CRADA Partner

    1. Assist in the isolation of recombinant proteins.
    2. Develop antisera and monoclonal antibodies to the KAI1 gene.
    3. Test the ability of antibodies to detect expression of the 
protein in histological sections.
    4. Develop in cooperation with the NIEHS diagnostic tests for 
malignant cancers on the basis of KAI1 expression.
    Selection criteria for choosing the CRADA partner(s) will include, 
but will not be limited to, the following:
    1. Experience in monoclonal antibody and antisera production.
    2. Capability to develop diagnostic tests for screening 
histological sections.

    Dated: July 6, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-17779 Filed 7-19-95; 8:45 am]
BILLING CODE 4140-01-P