Government-Owned Inventions; Availability for Licensing, 39544-39545 [2010-16800]

Download as PDF 39544 Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Activity Submission of rotational plans for health warning label statements 1 There Annual Frequency per Response 20 Total Annual Responses 1 20 Total Hours 100 2,000 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 2, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. Dated: July 2, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–16805 Filed 7–8–10; 8:45 am] BILLING CODE 4160–01–S [FR Doc. 2010–16741 Filed 7–8–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institutes of Health Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Preparedness and Emergency Response Learning Centers (PERLC) Panel, Request for Applications (RFA) TP10– 1001, Initial Review In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the aforementioned meeting: wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Hours per Response Times and Dates: 8:30 a.m.–5 p.m., July 27, 2010 (Closed). 8:30 a.m.–5 p.m., July 28, 2010 (Closed). 8:30 a.m.–5 p.m., July 29, 2010 (Closed). Place: The W Atlanta Hotel-Perimeter, Perimeter Center West, Atlanta, Georgia 30346, Telephone: (770) 396–6800. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Section 10(d) of Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Preparedness and Emergency Response Learning Centers (PERLC) Panel, RFA TP10–1001.’’ Agenda items are subject to change as priorities dictate. Contact Person for More Information: Shoukat Qari, Senior Scientific Program Official, Extramural Research Program, Office of Public Health Preparedness and Response, 1600 Clifton Road, Mailstop D–44, Atlanta, Georgia 30333, Telephone: (404) 639–7938, E-mail: SQari@cdc.gov. The Director, Management Analysis and Services Office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. VerDate Mar<15>2010 15:17 Jul 08, 2010 Jkt 220001 Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. 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 stemcell’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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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 nonrandom 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. E:\FR\FM\09JYN1.SGM 09JYN1 Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices 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; tongb@mail.nih.gov. 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 hewesj@mail.nih.gov for more information. wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 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. VerDate Mar<15>2010 15:17 Jul 08, 2010 Jkt 220001 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 halflives 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; Whitney.Hastings2@nih.gov. 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 39545 human IGF signaling pathway. Please contact John Hewes, Ph.D. at 301–435– 3121 or hewesj@mail.nih.gov 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 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. 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. Diagnostic H5N1 Avian Influenza Virus Peptides Description of Invention: The recent spread of highly pathogenic H5N1 avian influenza viruses among poultry and transmission of these viruses to humans raises concerns of a potential influenza pandemic. There is a need to track the spread of these viruses both in the animal and human populations to avert or reduce the impact of any potential influenza pandemic as well as to know the actual number (accurate surveillance) of people infected with H5N1, including individuals with subclinical H5N1 infection. The subject technology is a specific combination of H5N1 peptides useful for assays to detect antibodies generated E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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; 
tongb@mail.nih.gov.
    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 hewesj@mail.nih.gov 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; 
Whitney.Hastings2@nih.gov.
    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 hewesj@mail.nih.gov 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

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