[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Pages 39544-39545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16800]


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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.

Identification of Cancer Stem Cells

    Description of Invention: Cancer stem cells (CSC) are thought to be 
responsible for cancer initiation, maintenance, and therapeutic 
failure. A hallmark of stem cells is self-renewal via asymmetric cell 
division (ACD) into daughter stem-cells and cells predestined for 
differentiation. Demonstration of fundamental stem-cell's traits such 
as ACD in cancers is lacking. Label retaining cells are thought to be 
enriched for stem-like cells. Label retaining cells are thought to be 
the results of either very slow cycling cells and/or cells undergoing 
ACD. This invention is directed to the identification, isolation and 
purification of cancer stem cells by detecting asymmetrically dividing 
cells and/or label retaining cells. Detection of asymmetric cell 
division via non-random chromosomal cosegregation (ACD-NRCC) in various 
human cancers defines a unique and novel class of universal cancer stem 
cells, and potentially suggests a novel mechanism of carcinogenesis. 
The isolation of CSC might be used as a basis for a potential new 
strategy in cancer therapeutics. The invention also might have some 
implications in genetics and regenerative medicine.

Applications

     This invention may provide a novel way to target various 
cancers for treatment.
     This invention maybe also useful in regenerative medicine, 
i.e. spinal cord injury (regeneration of neurons), Alzheimer 
(regeneration of neurons) and Parkinson's disease regeneration of 
neurons).
    Development Status: Pre-clinical stage of development.

Market

     Cancer is the second leading cause of death in the U.S. 
The National Cancer Institute estimates the overall annual costs for 
cancer in the U.S. at $107 billion; $37 billion for direct medical 
costs, $11 billion for morbidity costs (cost of lost productivity), and 
$59 billion for mortality costs.
     According to statistics gathered by the National 
Institutes of Health, more than 10,000 Americans experience spinal cord 
injuries each year and more than 200,000 are living with permanent 
paralysis in their arms or legs due to spinal cord injury.
     Parkinson's disease affects some four million patients 
worldwide. Approximately 50,000 Americans are diagnosed with 
Parkinson's disease each year. Alzheimer Disease is estimated to affect 
5.09 million patients by 2010.
    Inventors: Itzhak Avital, Hong-Wu Xin, Danielle M. Hari (NCI)
    Publication: Manuscript submitted.

[[Page 39545]]

    Patent Status: U.S. Provisional Application No. 61/342,642 filed 16 
Apr 2010 (HHS Reference No. E-122-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The Center for Cancer Research, 
Surgery Branch, National Cancer Institute, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize our unique 
method for isolating cancer stem cells. We are seeking interested 
parties who would be interested in collaboration with the goal of 
developing cancer stem cell cell-lines for personalized targeted 
therapies, drug testing and finding novel targets for cancer 
treatments. In addition, we would like to collaborate with parties 
interested in developing normal (not cancer) adult tissue stem-cell 
cell-lines for adult tissue regeneration such as Parkinson's disease, 
liver failure, Alzheimer, etc. Please contact John Hewes, Ph.D. at 301-
435-3121 or [email protected] for more information.

Human Single-Domain Antibodies (dAbs) Against Insulin-Like Growth 
Factor 1 Receptor (IGF-1R) or Its Ligands, IGF-1 and IGF-2

    Description of Invention: Insulin-like growth factor (IGF) mediated 
signaling has been implicated in the development of several epithelial 
cancers, such as prostate, breast, and colorectal cancers. This 
technology consists of human single domain antibodies (dAbs) that bind 
to human insulin-like growth factor 1 receptor (IGF-1R) or its ligands, 
IGF-1 and IGF-2. These dAbs are comprised of only a single variable 
domain of an antibody with a human framework and three complementarity 
determining regions (CDRs). Several of these antibodies inhibit the IGF 
signaling pathway so they may be therapeutic candidates for the 
treatment of IGF-related cancers.

Applications

     A cancer therapeutic agent that inhibits the IGF-mediated 
signaling pathway.
     A diagnostic employing the detection of insulin-like 
growth factor 1 receptor (IGF-1R) or its ligands, IGF-1 and IGF-2, in a 
sample.

Advantages

     dAbs are about 10-fold smaller than IgG antibodies and 
exhibit dramatically increased penetration into solid tumors.
     dAbs can be produced in high yields at low cost, have 
favorable biophysical properties, and are well suited to engineering.
     dAbs are bioactive as monomers or can be linked into 
larger molecules to create drugs with prolonged serum half-lives or 
other pharmacological activities.
     dAbs can be fused to other polypeptides or other drugs to 
provide fusion proteins or conjugates.
     Human framework reduces potential for host immune 
reactions.

Market

     Cancer is the second most common cause of death in the US, 
exceeded only by heart disease. Survival varies greatly by cancer type 
and stage at diagnosis. The most recent estimate of the economic impact 
of cancer is that it costs the U.S. some $228.1 billion annually. 
Hence, there is a need for the development of medical products that can 
improve the treatment of cancer patients.
     In the U.S., over 2.4 million new cancer cases are 
diagnosed yearly. A large proportion of these diagnoses are due to 
carcinomas of the breast, prostate, colon, lung, pancreas, and bladder. 
Monoclonal antibodies are increasingly being used to treat these 
cancers leading to sales of $13.6 billion in 2008 with a market share 
of 28.6% of total sales.
    Development Status: Early-stage development.
    Inventors: Dimiter S. Dimitrov and Weizao Chen (NCI).
    Publications: Chen W, Zhu Z, Feng Y, Dimitrov DS. A large human 
domain antibody library combining heavy and light chain CDR3 diversity. 
Mol Immunol. 2010 Jan;47(4):912-921. [PubMed: 19883941].
    Patent Status: U.S. Provisional Application No. 61/249,476 filed 07 
Oct 2009 (HHS Reference No. E-232-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The Center for Cancer Research 
Nanobiology Program (CCRNP), National Cancer Institute, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the dAbs that exhibit potent inhibitory activities against the human 
IGF signaling pathway. Please contact John Hewes, Ph.D. at 301-435-3121 
or [email protected] for more information.

    Dated: July 2, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-16800 Filed 7-8-10; 8:45 am]
BILLING CODE 4140-01-P