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

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).

ADDRESS: Proposals and 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.

DATE: Capability statements must be received by NIH on or before
[insert date 60 days after date of publication in the Federal
Register].

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. 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.