[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Notices]
[Pages 112-113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31238]


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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

[[Page 113]]

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.

Novel Inhibitor of NF-kappa B Pathway

    Description of Technology: Many tumors and blood cell cancers show 
overactivation of the NF-kappa B signal transduction pathway. This 
overactivation is associated with cancer forming in the colon, liver 
and other epithelial sites. In addition, there is evidence that 
overactivation leads to tumor formation and metastasis. However, this 
pathway is key for normal immunity, so any inhibition of NF-kappa B 
overactivation must avoid diminishing the body's ability to fight 
infection.
    This invention claims a compound that inhibits NF-kappa B 
activation without affecting other transcription factors such as AP-1 
and SRE binding proteins. It appears to function by blocking IKK beta 
and is effective at low micromolar concentrations without affecting 
cell proliferation or cell survival. At this low concentration, NF-
kappa B is reduced to basal levels so this novel compound has prospects 
for preventing or treating cancer without being detrimental to 
immunity. In addition, because NF-kappa B overactivation contributes to 
a variety of inflammatory disorders including colitis, diabetes, 
prostatitis, and pancreatitis this compound has therapeutic 
applications beyond cancer.
    Applications:
     Therapeutic for the chemoprevention or treatment of 
cancers associated with the overactivation of NF-kappa B signaling 
pathway.
     Therapeutic for the treatment of inflammatory disorders 
related to NF-kappa B overactivation.
     Reagent for the diagnosis of conditions related to 
overexpression of NF-kappa B.
    Advantages:
     Highly specific inhibitor that allows targeting NF-kappa B 
without inhibiting other transcription factors.
     Effective at preventing carcinogenesis without affecting 
normal cell proliferation and survival.
     Therapeutic for treatment of cancer that will not 
compromise the immune system.
    Development Status: Early stage.
    Market: Cancer is the second leading cause of death in the U.S. and 
it is estimated that 1.4 million Americans develop cancer in a year.
    Inventors: Curtis J. Henrich et al. (NCI).
    Publications: None related to invention have been published.
    Patent Status: U.S. Provisional Application No. 61/098,977 filed 22 
Sep 2008 (HHS Reference No. E-295-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sabarni K. Chatterjee, Ph.D.; 301-435-5587; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
(SAIC-Frederick) is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize around development of analogs and/or further 
investigations of mechanism of action of the compound. Please contact 
John D. Hewes, Ph.D. at 301-435-3121 or [email protected] for more 
information.

Method for Predicting and Detecting Tumor Metastasis

    Description of Technology: Detecting cancer prior to metastasis 
greatly increases the efficacy of treatment and the chances of patient 
survival. Although numerous biomarkers have been reported to identify 
aggressive tumor types and predict prognosis, each biomarker is 
specific for a particular type of cancer, and no universal marker that 
can predict metastasis in a number of cancers have been identified. In 
addition, due to a lack of reliability, several markers are typically 
required to determine the prognosis and course of therapy.
    The inventors discovered a novel CPE splice variant designated CPE-
[utri]N and found its expression levels increase according to the 
presence of cancer and metastasis wherein this variant is upregulated 
in tumors and further increased in metastatic cancer. This data has 
been demonstrated both in vitro and in vivo experiments and in liver, 
breast, prostate, colon, and head and neck cancers. Metastatic liver 
cells treated with CPE-[utri]N siRNA reversed the cells from being 
metastatic and arrested cells from further metastasis. Thus, this novel 
CPE isoform is a biomarker for predicting metastasis and its inhibitors 
have an enormous potential to increase patient survival.
    Applications:
     Method to prognose multiple types of cancer and determine 
likelihood of metastasis.
     Method to prevent and treat cancer with CPE inhibitors.
     Method to determine the stage of cancer development.
     CPE-[utri]N pharmaceutical compositions.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market:
     Global cancer market is worth more than eight percent of 
total global pharmaceutical sales.
     Cancer industry is predicted to expand to $85.3 billion by 
2010.
    Inventors: Y. Peng Loh et al. (NICHD).
    Patent Status: U.S. Provisional Application No. 61/080,508 filed 14 
Jul 2008 (HHS Reference No. E-234-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Laboratory of Development Neurobiology, 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize Method for Predicting and Detecting Tumor Metastasis. 
Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

    Dated: December 23, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-31238 Filed 12-31-08; 8:45 am]
BILLING CODE 4140-01-P