[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Notices]
[Pages 24317-24318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8356]


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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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[[Page 24318]]

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.

Diagnosing and Treating Cancer Using Beta-Catenin Splice Variants

    Description of Technology: This application discloses and claims 
inventions which may be used alone or together. One group of inventions 
relates to early detection diagnostic, prognostic and patient 
monitoring methods (``Diagnostic Methods''). The other group of 
inventions relates to methods of treatment. Both groups of inventions 
have particular application with respect to esophageal squamous cell 
cancers (ESCC) or other types of adenocarcinomas and squamous cell 
carcinomas.
    The Diagnostic Methods are useful in evaluating the status of 
preneoplastic lesions as well as tumor tissue. Because of this, the 
methods can be used to track the progression or regression of disease 
in many types of cell samples from normal to dysplasia to cancer.
    The Diagnostic Methods involve measuring the level of one or more 
pairs of transcripts or the protein products of these pairs of 
transcripts or the cellular localization of the transcripts or 
proteins. The primary transcripts or protein products useful in this 
method are those of the beta-Catenin gene (CTNNB1). In particular, the 
levels of the 16A and 16B CTNNB1 transcripts or protein products are of 
importance in carrying out the methods of this patent application. 
Other gene transcripts or protein products that may be used in 
conjunction with CTNNB1 16A and 16B to provide additional information 
are WAF1 (p21) and cMYC.
    The treatment methods include employing small interfering RNA 
molecules (siRNAs) as a means to alter the expression of one or more of 
these particular CTNNB1 transcripts. More specifically, preferred siRNA 
molecules can be used to alter the expression of the CTNNB1 transcripts 
16A and/or 16B. These siRNA molecules may be single-stranded (ss) or 
double-stranded (ds) and may be delivered using a construct capable of 
producing the siRNA molecule upon delivery to the target cell.
    Applications: Diagnostic or prognostic methods for squamous cell 
cancers and adenocarcinomas; Monitoring therapeutic response during and 
after patient treatment; Development of cancer treatments; Basic 
research to further elucidate the role of beta catenin in signal 
transduction pathways and carcinogenesis.
    Development Stage: The use of beta catenin transcripts to provide 
prognostic or diagnostic information remains the subject of research 
but early patient data is found in the article in Genes Chromosomes & 
Cancer listed below. Work related to the use of siRNA as a treatment 
strategy remains in its early stages of research and has not yet 
progressed to clinical trials.
    Inventors: Mark J. Roth and Konrad Huppi (NCI).
    Publications:
    1. The patent application has been published as WO 2006/086772 A2 
on 17 August 2006.
    2. MJ Roth et al. beta-Catenin splice variants and downstream 
targets as markers for neoplastic progression of esophageal cancer. 
Genes Chromosomes Cancer. 2005 Dec;44(4):423-428.
    3. SE Martin et al. Multiplexing siRNAs to compress RNAi-based 
screen size in human cells. Nucleic Acids Res. 2007 Mar 28; E published 
ahead of print, doi:10.1093/nar/gkm141.
    4. A Thiele et al. AU-rich elements and alternative splicing in the 
beta-Catenin 3' UTR can influence the human beta-Catenin mRNA 
stability. Exp Cell Res. 2006 Jul;312:2367-2378.
    Patent Status:
    PCT/US2006/05032 filed 10 Feb 2006 and published as WO 2006/086772 
on 17 Aug 2006, currently pending, entitled ``Method of Diagnosing and 
Treating Cancer Using Beta Catenin Splice Variants'' (HHS Reference No. 
E-018-2005/2-PCT-01);
    U.S. Provisional Application No. 60/667,084 filed 30 Mar 2005, now 
abandoned (HHS Reference No. E-018-2005/1-US-01);
    U.S. Provisional Application No. 60/652,154 filed 10 Feb 2005, now 
abandoned (HHS Reference No. E-018-2005/0-US-01).
    Biological Materials Availability: Biological materials related to 
this technology are available and include those referred to in the 
following publications as well as a series of recently established 
aptamers capable of specific binding to the CTNNB1 protein.
    1. MJ Roth et al. Cytologic detection of esophageal squamous cell 
carcinoma and precursor lesions using balloon and sponge samplers in 
asymptomatic adults in Linxian, China. Cancer. 1997 Dec 1;80(11):2047-
2059.
    2. Q-J Pan et al. Cytologic detection of esophageal squamous cell 
carcinoma and its precursor lesions using balloon samplers and liquid-
based cytology in asymptomatic adults in Linxian, China. ACTA 
Cytologica (In Press).
    3. MJ Roth et al. A study of beta-catenin splice variants and 
associated downstream targets as markers for neoplastic progression of 
squamous cell carcinoma of the esophagus. Genes Chromosomes Cancer. 
2005 Dec;44(4):423-428.
    4. PJ Limburg et al. Randomized, placebo-controlled esphogeal 
squamous cell cancer chemoprevention trial of selenomethionine and 
celecoxib. Gastroenterology. 2005 Sept;129(3):863-873.
    Licensing Availability: This application is available for license 
on a non-exclusive or exclusive basis.
    Licensing Contact: Susan S. Rucker, Esq.; 301/435-4478; 
[email protected]
    Collaborative Research Opportunity: The National Cancer Institute, 
Division of Cancer Epidemiology and Genetics, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize a method of 
diagnosing and treating cancer using beta-Catenin splice variants. 
Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information. 8356

    Dated: April 25, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-8356 Filed 5-1-07; 8:45 am]
BILLING CODE 4140-01-P