[Federal Register Volume 72, Number 118 (Wednesday, June 20, 2007)]
[Notices]
[Pages 34020-34021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11825]


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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.

NUP98-HOXD13 Transgenic Mice

    Description of Technology: Myelodysplastic syndrome (MDS) is 
collection of closely related blood diseases that arise in the bone 
marrow characterized by anemia, neutropenia, and thrombocytopenia 
resulting from hematopoietic stem cell disorders. A variety of genetic 
aberrations have been associated with MDS, including chromosomal 
translocations of the NUP98 gene. The only current curative therapy for 
MDS is allogeneic bone marrow transplant. Without bone marrow 
transplant, patients either die of progressive pancytopenia or 
following transformation of MDS to acute myeloid leukemia. Progress in 
understanding and treating MDS has been hampered by a lack of an animal 
model that accurately recapitulates all of the features of human MDS. 
Utilizing a NUP98-HOXD13 (hereafter NHD13) fusion gene, a mouse model 
was developed to elucidate the biology of MDS. Genetically engineered 
mice that express an NHD13 transgene display all of the phenotypic 
features of MDS including peripheral blood cytopenia, bone marrow 
dysplasia, and transformation to acute leukemia. These mice provide an 
accurate preclinical model for MDS.
    Applications: Model to study MDS and evaluate MDS therapy.
    Market: 15,000-20,000 new cases of MDS are diagnosed in the U.S.; 
80-90% of patients are older than 60 years old.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Peter D. Aplan et al. (NCI).
    Publications:
    1. YW Lin et al. Notch1 mutations are important for leukemic 
transformation in murine models of precursor-T leukemia/lymphoma. 
Blood. 2006 Mar 15;107(6):2540-2543.
    2. YW Lin et al., NUP98-HOXD13 transgenic mice develop a highly 
penetrant, severe myelodysplastic syndrome that progresses to acute 
leukemia. Blood. 2005 Jul 1;106(1):287-295.
    Patent Status: HHS Reference No. E-071-2007/0--Research Tool.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The Leukemia Biology Section, 
Genetics Branch, National Cancer Institute is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the NHD13 mouse 
model. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

Identification of Ovarian Cancer Tumor Markers and Therapeutic Agents

    Description of Technology: Germline mutations of BRCA1 and BRCA2 
tumor suppressor genes are responsible for 5%-10% of all epithelial 
ovarian cancers. However, little is known about the molecular 
mechanisms involved in BRCA1 and/or BRCA2 mutation-associated (termed 
BRCA-linked) ovarian carcinogenesis. To elucidate their pathways, 
microarrays were used to compare gene expression patterns in ovarian 
cancers associated with BRCA1 or BRCA2 mutations with gene expression 
patterns in sporadic epithelial ovarian cancers to identify patterns 
common to both hereditary and sporadic tumors. As a result of this 
analysis, genes that are upregulated in ovarian cancer were identified. 
Approximately two-thirds of the sequences identified were previously 
known genes, while approximately one-third were expressed sequence 
tags, representing sequences that are cloned and identified but not yet 
characterized. Eighty-three genes were over-expressed in 50% of all 
tumors and these over-expressed sequences may be used as markers for 
ovarian cancer and/or targets for therapy.
    Applications: Method to diagnose ovarian cancer; Method to treat 
ovarian cancer with therapeutics that target ovarian biomarkers; 
Ovarian cancer therapeutics that inhibit ovarian cancer markers such as 
siRNA.
    Market: Estimated 180,000 new cases of breast cancer in the U.S. in 
2007; Estimated 41,000 deaths due to breast cancer in the U.S. in 2007.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Amir Jazaeri (NCI), Edison T. Liu (NCI), et al.
    Publications:
    1. AA Jazaeri et al. BRCA1-mediated repression of select X 
chromosome genes. J Transl Med. 2004 Sep 21;2(1):32.
    2. AA Jazaeri et al. Molecular determinants of tumor 
differentiation in papillary serous ovarian carcinoma. Mol Carcinog. 
2003 Feb;36(2):53-59.
    3. AA Jazaeri et al. Gene expression profiles of BRCA1-linked, 
BRCA2-linked, and sporadic ovarian cancers. J Natl Cancer Inst. 2002 
Jul 3;94(13):990-1000.
    Patent Status: U.S. Provisional Application No. 60/357,031 filed 13 
Feb 2002 (HHS Reference No. E-310-2001/0-US-01); PCT Patent Application 
No. PCT/US2003/046888 filed 13 Feb 2003 (HHS Reference No. E-310-2001/
0-PCT-02); U.S. Patent Application No. 10/505,680 filed 12 Aug 2004 
(HHS Reference No. E-310-2001/0-US-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

Tumor Markers in Ovarian Cancer

    Description of Technology: Ovarian cancer is one of the most common 
forms of neoplasia in women. Although advanced ovarian cancer has only 
a 20-30% survival rate, an estimated 90% of cases are effectively 
treated when detected early. However, few symptoms are associated with 
early ovarian cancer, and approximately 25% of ovarian cancer cases are 
diagnosed before it metastasizes. Utilizing SAGE analysis, a unique set 
of ovarian cancer biomarkers has been identified that are highly 
expressed in ovarian epithelial tumor

[[Page 34021]]

cells in comparison to normal ovarian epithelial cells. A better 
knowledge of the mechanisms underlying ovarian tumorigenesis will 
likely result in the development of novel approaches for the diagnosis 
and therapy of this deadly disease.
    Applications: Method to diagnose ovarian cancer; Methods to treat 
patients with compositions that inhibit ovarian biomarkers such as 
siRNA.
    Market: Ovarian cancer is the fourth most common form of cancer in 
the U.S.; Ovarian cancer is three times more lethal than breast cancer; 
22,430 new cases of ovarian cancer expected in 2007; 15,280 ovarian 
cancer deaths in the U.S. in 2007.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Patrice J. Morin et al. (NIA).
    Related Publications:
    1. KJ Hewitt, R Agarwal, PJ Morin. The claudin gene family: 
expression in normal and neoplastic tissues. BMC Cancer. 2006 Jul 
12;6:186.
    2. PJ Morin. Claudin proteins in human cancer: promising new 
targets for diagnosis and therapy. Cancer Res. 2005 Nov 1;65(21):9603-
9606.
    3. R Agarwal, T D'Souza, PJ Morin. Claudin-3 and claudin-4 
expression in ovarian epithelial cells enhances invasion and is 
associated with increased matrix metalloproteinase-2 activity. Cancer 
Res. 2005 Aug 15;65(16):7378-7385.
    4. CD Hough, CA Sherman-Baust, ES Pizer, PJ Morin. Use of SAGE to 
study gene expression in ovarian cancer. American Association for 
Cancer Research, 9th Annual Meeting, April 10-14, 1999, Philadelphia, 
Pennsylvania.
    Patent Status: U.S. Provisional Application No. 60/194,336 filed 03 
Apr 2000 (HHS Reference No. E-138-2000/0-US-01); PCT Patent Application 
No. PCT/US2001/10947 filed 03 Apr 2001, which published as WO 01/75177 
on 11 Oct 2001 (HHS Reference No. E-138-2000/0-PCT-02); U.S. Patent 
Application No. 10/257,021 filed 03 Oct 2002 (HHS Reference No. E-138-
2000/0-US-03)
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

    Dated: June 8, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer,Office of 
Technology Transfer,National Institutes of Health.
 [FR Doc. E7-11825 Filed 6-19-07; 8:45 am]
BILLING CODE 4140-01-P