[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Notices]
[Pages 30807-30808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10712]


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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.

A MicroRNA Profile for Androgen Responsive Prostate Cancer

    Description of Technology: This invention describes a microRNA gene 
expression profile in prostate cancers that correlates with androgen 
responsiveness. Most prostate cancers are androgen sensitive and can be 
treated with anti-androgen therapies. Tumors non-responsive to anti-
androgen therapy are more aggressive and needs alternative therapeutic 
interventions. Additionally, the microRNAs discovered can also be 
potential targets for developing new prostate cancer drugs.
    Applications: MicroRNA expression profile can help physicians take 
informed treatment action on an individual basis.
    Advantages: In vitro proof-of-concept data available.
    Inventors: Dr. Chang Hee Kim et al. (NCI).
    Related Publications: A manuscript directly related to this 
technology will be available as soon as it is accepted for publication.
    Patent Status: U.S. Provisional Application No. 60/906,742 filed 12 
Mar 2007 (HHS Reference No. E-142-2007/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; 
[email protected].
    Collaborative Research Opportunity: The NCI/SAIC-Frederick, 
Advanced Technology Program, Laboratory for Molecular Technology, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
microRNA diagnostic markers in cancer. Please contact John D. Hewes, 
Ph.D. at 301-435-3121 or [email protected] for more information.

A Gene Expression Signature Identifying Pro-Angiogenic Genes in Ovarian 
Tumor Endothelial Cell Isolates

    Description of Technology: Cancer is a heterogeneous disease that 
requires multimodality therapy. Most of the therapeutic approaches for 
ovarian cancer have focused on chemotherapy, which primarily targets 
proliferating tumor cells. Women with ovarian cancer are typically 
asymptomatic and they are often diagnosed at an advanced stage and have 
poor survival. Despite an 80% positive patient response rate to surgery 
and chemotherapy, most patients will experience tumor recurrence within 
two years. A majority of women who die of ovarian cancer will have 
ovarian epithelial carcinomas.
    The inventors have discovered a unique proangiogenic biomarkers 
isolated from ovarian endothelial cells. By targeting tumor 
angiogenesis by inhibiting endothelial cells that support tumor growth, 
this technology provides methods to diagnose an ovarian cancer in its 
early stages.
    Applications: Method to diagnose and treat ovarian cancer in its 
early stage; Novel early stage ovarian cancer biomarkers; Therapeutic 
targets and compositions that inhibit ovarian tumors such as siRNA.
    Market: Ovarian cancer is the seventh most common cancer and the 
fifth leading cause of cancer death in the U.S; An estimated 15,310 
deaths in the U.S. in 2006.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Michael J. Birrer (NCI) et al.
    Publication: C Lu et al. Gene alterations identified by expression 
profiling in tumor-associated endothelial cells from invasive ovarian 
carcinoma. Cancer Res. 2007 Feb 15;67(4):1757-1768.
    Patent Status: U.S. Provisional Application No. 60/901,455 filed 14 
Feb 2007 (HHS Reference No. E-095-2007/0-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 Cancer Institute, 
Cell and Cancer Biology Branch, Molecular Mechanisms Section, is 
seeking statements of capability or interest from parties interested in 
collaborative

[[Page 30808]]

research to further develop, evaluate, or commercialize this 
technology. Please contact John D. Hewes, Ph.D., at 301/435-3121 or 
[email protected] for more information.

Conjugates of Ligand, Linker, and Cytotoxic Agent and Related 
Compositions and Methods of Use

    Description of Technology: Systemic toxicity of drugs is one of the 
most serious problems in cancer chemotherapy and frequently is dose 
limiting. Specific delivery of cytotoxic drugs to cancer cells remains 
among the most intractable problems of cancer therapy. Targeted 
delivery of anti-proliferation drugs through the cell surface receptors 
that are over expressed on cancer cells can reduce systemic toxicity 
and increase effectiveness of a treatment.
    The present invention describes cytotoxic compounds with an 
intracellular target that can selectively enter tumor cells through 
specific receptors on the cell surface. The invention also describes a 
conjugate comprising a cytotoxic agent, a linker arm and a ligand 
capable of delivering a cytotoxic agent in a cell specific manner. Such 
conjugates of a cytotoxic agent and a ligand (delivery moiety) have 
increased selectivity for tumor cells. The toxic moiety and the ligand 
are joined by a linker arm that is stable in circulation, but is easily 
cleaved in lysosomes upon internalization of the conjugate. A panel of 
compounds comprised of a variety of cytotoxic warheads, against various 
intracellular targets linked to an assortment of ligands, has been 
developed and tested in a model system. Ligand moieties of these 
conjugates are capable of specific delivery of cytotoxic agents to 
receptors that are frequently over expressed in gastric, colon, lung, 
breast, ovarian and pancreatic tumors. These compounds have the 
potential to be highly effective anti-tumor agents with considerably 
little negative effect. This disclosed technology could provide new and 
exciting methodologies to treat cancer.
    Inventors: Nadya I. Tarasova et al. (NCI)
    Patent Status: U.S. Patent Application No. 10/505,239 filed 19 Aug 
2004, claiming priority to 27 Feb 2002 (HHS Reference No. E-057-2002/2-
US-02).
    Licensing Contact: Adaku Nwachukwu, J.D.; 301/435-5560; 
[email protected].

DLC-1 Gene Deleted in Cancers

    Description of Technology: Chromosomal regions that are frequently 
deleted in cancer cells are thought to be the loci of tumor suppressor 
genes, which restrict cell proliferation. Recurrent deletions on the 
short arm of human chromosome 8 in liver, breast, lung and prostate 
cancers have raised the possibility of the presence of tumor suppressor 
genes in this location.
    The inventors have discovered the deletion of human DLC-1 gene in 
hepatocellular cancer (HCC) cells. They have performed in vitro 
experiments demonstrating the deletion in over 40% of human primary HCC 
and in 90% of HCC cell lines. The DLC-1 gene is located on human 
chromosome 8p21.3-22, a region frequently deleted in many types of 
human cancer. DLC-1 mRNA is expressed in all normal tissues tested, but 
it has either no or low expression in a high percentage of several 
types of human cancer, such as liver, breast, lung, and prostate 
cancers. Through in vitro and in vivo tumor suppression experiments, 
the inventors further demonstrated that DLC-1 acts as a new tumor 
suppressor gene for different types of human cancer.
    Applications: Method to diagnose HCC; Method to treat HCC patients 
with DLC-1 compositions; Transgenic model to study HCC and other types 
of human cancer; DLC-1 compositions.
    Market: Primary liver cancer accounts for about 2% of cancers in 
the U.S., but up to half of all cancers in some undeveloped countries; 
251,000 new cases are reported annually; post-operative five year 
survival rate of HCC patients is 30-40%.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Bao-Zhu Yuan, Snorri S. Thorgeirsson, Nicholas Popescu 
(NCI).
    Publications: 1. BZ Yuan et al. DLC-1 operates as a tumor 
suppressor gene in human non-small cell lung carcinomas. Oncogene. 2004 
Feb 19;23(7):1405-1411.
    2. BZ Yuan et al. DLC-1 gene inhibits human breast cancer cell 
growth and in vitro tumorigenicity. Oncogene. 2003 Jan 23;22(3):445-
450.
    3. BZ Yuan et al. Promoter hypermethylation of DLC-1, a candidate 
tumor suppressor gene, in several common human cancers. Cancer Genet 
Cytogenet. 2003 Jan 15;140(2):113-117.
    4. BZ Yuan et al. Cloning, characterization, and chromosomal 
localization of a gene frequently deleted in human liver cancer (DLC-1) 
homologous to rat RhoGAP. Cancer Res. 1998 May15;58(10):2196-2199.
    Patent Status: U.S. Patent No. 6,897,018 issued 24 May 2005 (HHS 
Reference No. E-042-1998/0-US-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; [email protected]
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Experimental Carcinogenesis, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize diagnostics 
based on tumor suppressor genes. Please contact John D. Hewes, Ph.D., 
at 301/435-3121 or [email protected] for more information.

    Dated: May 23, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-10712 Filed 6-1-07; 8:45 am]
BILLING CODE 4140-01-P