[Federal Register Volume 73, Number 144 (Friday, July 25, 2008)]
[Notices]
[Pages 43455-43456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Prolactin Receptor Antibodies as a Diagnostic Marker and Therapeutic 
Agent for Cancer

    Description of Technology: Prolactin is a key hormone in the normal 
breast development and plays a role in the growth and development of 
other major organs such as the prostate. The biologic function of 
prolactin is mediated by specific receptors on the cell surface, with 
breast cancer cells containing more receptors than normal tissue. The 
prolactin receptor, a member of the large class-1 cytokine receptor 
superfamily, has three major isoforms that are cell associated. The 
specific isoform concentration and distribution determines biological 
activity and may determine susceptibility to antiprolactin drugs.
    This technology describes several antibodies, both polyclonal and 
monoclonal, to the prolactin receptor. These include antibodies to the 
three major isoforms: the long isoform (LF), two short isoforms (SF1a 
and SF1b), and the secreted form, prolactin receptor [Delta]7-11. These 
antibodies can be used for the diagnosis of prolactin sensitive tumors. 
Furthermore, the presence of the secreted prolactin receptor [Delta]7-
11 may provide a blood test for prolactin responsive tumors.
    Applications:
     Diagnostic tool for the detection of prolactin sensitive 
tumors.
     Antibodies as a serum diagnostic in high-throughput 
assays.
     Conjugated antibodies used in targeted therapy of cancer.
    Market:
     In the U.S. over 2 million women have been treated for 
breast cancer and with more than 200,000 women diagnosed in the year 
2007 alone. Breast cancer is the second leading cause of cancer death 
in women.
     Prostate cancer is the most common type of cancer found in 
American men, and it has been estimated that there were more than 
230,000 new cases in the U.S. in 2007. Prostate cancer is also the 
second leading cause of cancer death in men.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Barbara Vonderhaar, Erika Ginsburg, Paul Goldsmith 
(NCI).
    Patent Status: HHS Reference No. E-232-2008/0--Research Material. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Mammary Biology and Tumorigenesis Laboratory is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize isoform 
specific antibodies to the human prolactin receptor. Please contact 
John D. Hewes, PhD, at 301-435-3121 or [email protected] for more 
information.

Mouse Embryonic Stem Cell-Based Functional Assay To Evaluate Mutations 
in BRCA2

    Description of Technology: Mutations in breast cancer 
susceptibility genes BRCA1 and BRCA2 have up to an 80% life time risk 
in developing breast cancer. There are no ``mutation hot spots'' and to 
date, more than 1,500 different mutations have been identified in 
BRCA2. The absence of tumor cell lines expressing various mutant BRCA2 
alleles has hindered evaluations to determine the functional 
differences between different mutations.
    A simple, versatile and reliable mouse embryonic stem cell and 
bacterial artificial chromosome based assay to generate cell lines 
expressing mutant human BRCA2 has been developed and it has been used 
to classify 17 sequence variants. Available for licensing are a wild-
type and eleven mutant BRCA2 cell lines developed from this assay that 
have either truncations or point mutations. These cell lines may be 
used to evaluate the effect of DNA damaging agents, genotoxins and 
chemotherapeutic efficacy.
    Applications:
     Research tool to generate and study BRCA2 mutations.
     Method to screen for chemotherapeutics.
     Method to evaluate DNA damaging agents.
    Advantages: Ready to use portfolio of BRCA2 mutant cell lines to 
study BRCA2 mutant functional analysis.
    Market: An estimated 180,510 new cases of breast cancer will be 
diagnosed and may cause 40,480 deaths in the U.S. in 2008.
    Inventors: Shyam K. Sharan and Sergey Kuznetsov (NCI).
    Publication: SG Kuznetsov et al. Mouse embryonic stem cell-based 
functional assay to evaluate mutations in BRCA2. Nat Med. 2008, in 
press. Published online 11 July 2008, doi:10.1038/nm.1719.
    Patent Status: HHS Reference No. E-261-2007/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for biological materials licensing 
only.
    Licensing Contact: Jennifer Wong; (301) 435-4633; 
[email protected].
    Collaborative Research Opportunity: The Mouse Cancer Genetics 
Program, Center for Cancer Research, National Cancer Institute, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
mouse embryonic stem cell lines suitable for functional analysis of 
BRCA2 variants. Please contact John D. Hewes, PhD, at 301-435-3121 or 
[email protected] for more information.


[[Page 43456]]


    Dated: July 17, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-17031 Filed 7-24-08; 8:45 am]
BILLING CODE 4140-01-P