Government-Owned Inventions; Availability for Licensing, 48215-48216 [E8-18982]
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Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Notices
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Christine D. Berg, Chief, Early Detection
Research Group, National Cancer
Institute, NIH, EPN Building, Room
3070, 6130 Executive Boulevard,
Bethesda, MD 20892, or call non-tollfree number 301–496–8544 or e-mail
your request, including your address to:
Bergc@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: August 5, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office,
National Institutes of Health.
[FR Doc. E8–18981 Filed 8–19–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
sroberts on PROD1PC70 with NOTICES
AGENCY:
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
VerDate Aug<31>2005
16:50 Aug 15, 2008
Jkt 214001
be required to receive copies of the
patent applications.
Extracellular Matrix Gene Chips To
Detect Metastatic Tumors
Description of Technology: Cancer
mortality is primarily associated with
metastatic disease and not the primary
tumor. Recent evidence suggests that
metastatic disease can be an early event
and in the majority of patients
metastasis starts by the time the disease
is diagnosed. Currently however,
approximately one third of patients
without evidence of tumor
dissemination at the time of surgical
resection of the primary tumor
subsequently develop distant metastases
after the tumor is removed. Therefore
there is a need for methods of
characterizing the early metastatic
process for better treatment of cancer.
This invention provides arrays which
can be used for detecting the metastatic
capacity of a tumor. In particular, these
gene chips or microarrays detect the
over-expression of the cancer-related
extracellular matrix (ECM) modifier
proteins Anakin and Bromodomain 4
(Brd4). It has been shown that ECM gene
dysregulation is predictive of metastasis
in breast cancer and recently Brd4 and
Anakin have been identified as
metastasis modifiers.
Using the signature profiles of Anakin
and Brd4, the inventors have
demonstrated that these genes predict
survival outcome in affymetrix and glass
slide based microarray experiments. As
a result, screening for Brd4 and/or
Anakin status in tumors could be an
important prognostic test and may
enable physicians to better stratify
patients based on risk of recurrence and
progression to metastatic disease.
Applications:
• Detecting metastatic disease in
patients diagnosed with cancer.
• Method of characterizing a tumor or
cancer by detecting the expression
levels of Anakin or Brd4.
• Diagnostic tool to aid clinicians in
determining appropriate cancer
treatment.
Market:
• Approximately 1,437,180 new
cancer cases are expected to be
diagnosed in 2008.
• Almost 565,650 people in the U.S.
are expected to die of cancer. This is
more than 1,500 people a day.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Kent Hunter and Nigel
Crawford (NCI).
Patent Status: U.S. Provisional
Application No. 60/970,400 filed 06 Sep
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
48215
2007 (HHS Reference No. E–093–2007/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney A.
Hastings; 301–451–7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Metastasis
Susceptibility Section of the Laboratory
of Cancer Biology and Genetics is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
Brd4 and/or RRP1B (Anakin) prognostic
tests. Please contact John D. Hewes,
Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
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.
E:\FR\FM\18AUN1.SGM
18AUN1
48216
Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Notices
sroberts on PROD1PC70 with NOTICES
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 nonexclusive licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
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 hewesj@mail.nih.gov 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 antiproliferation 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
VerDate Aug<31>2005
16:50 Aug 15, 2008
Jkt 214001
little negative effect. This disclosed
technology could provide new and
exciting methodologies to treat cancer.
Applications: Anti-tumor agent for
gastric, colon, lung, breast, ovarian and
pancreatic tumors.
Development Status: The technology
is currently in the pre-clinical stage of
development.
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;
madua@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Structural
Biophysics Laboratory is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize Conjugates of Ligand,
Linker, and Cytotoxic Agent and Related
Compositions and Methods of Use.
Please contact John D. Hewes, Ph.D. at
301–435–3121 or hewesj@mail.nih.gov
for more information.
SH2 Domain Binding Inhibitors
Description of Technology: Signal
transduction processes underlie the
transfer of extracellular information to
the interior of the cell and ultimately to
the nucleus. A variety of signal
transduction processes are critical for
normal cellular homeostasis, with
protein-tyrosine kinases (PTKs) playing
central roles in many of these pathways.
Examples of such PTKs include the
PDGF receptor, the FGF receptor, the
HGF receptor, members of the EGF
receptor family, such as the EGF
receptor, erb-B2, erb-B3 and erb-B4, the
src kinase family, Fak kinase and the Jak
kinase family. Protein-tyrosine
phosphorylation that results from the
action of PTKs can modulate the activity
of certain target enzymes as well as
facilitate the formation of specific multiprotein signaling complexes through the
actions of homologous protein modules
termed Src homology 2 (SH2) domains,
which recognize specific
phosphotyrosyl containing sequences. A
malfunction in this system through
tyrosine kinase overexpression and/or
deregulation can be manifested by
various oncogenic and
hyperproliferative disorders, including
cancers, inflammation, autoimmune
disease, hyperproliferative skin
disorders, psoriasis and allergy/asthma,
etc. The disclosed compounds, e.g.
peptides, preferably, macrocyclic
peptides, are Grb2 SH2 domain
signaling antagonists with enhanced
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
binding affinity. The claims of the
current application are directed to
compositions of matter and methods of
use which provide for the diagnosis,
testing and treatment of the
aforementioned disease states.
Applications: For treatment of cancer,
inflammation, autoimmune diseases,
hyperproliferative skin disorders,
psoriasis and asthma.
Development Status: The technology
is currently in an early pre-clinical stage
of development.
Inventors: Terrence R. Burke, Jr., et al.
(NCI).
Patent Status:
• U.S. Patent No. 6,977,241 issued 20
Dec 2005 (HHS Reference No. E–262–
2000/0–US–03).
• U.S. Patent Application No. 10/
517,717 filed 17 Mar 2005, allowed
(HHS Reference No. E–262–2000/1-US–
03).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Adaku
Nwachukwu, J.D.; 301–435–5560;
madua@mail.nih.gov.
Dated: August 7, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–18982 Filed 8–19–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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/
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 73, Number 160 (Monday, August 18, 2008)]
[Notices]
[Pages 48215-48216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18982]
-----------------------------------------------------------------------
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.
Extracellular Matrix Gene Chips To Detect Metastatic Tumors
Description of Technology: Cancer mortality is primarily associated
with metastatic disease and not the primary tumor. Recent evidence
suggests that metastatic disease can be an early event and in the
majority of patients metastasis starts by the time the disease is
diagnosed. Currently however, approximately one third of patients
without evidence of tumor dissemination at the time of surgical
resection of the primary tumor subsequently develop distant metastases
after the tumor is removed. Therefore there is a need for methods of
characterizing the early metastatic process for better treatment of
cancer.
This invention provides arrays which can be used for detecting the
metastatic capacity of a tumor. In particular, these gene chips or
microarrays detect the over-expression of the cancer-related
extracellular matrix (ECM) modifier proteins Anakin and Bromodomain 4
(Brd4). It has been shown that ECM gene dysregulation is predictive of
metastasis in breast cancer and recently Brd4 and Anakin have been
identified as metastasis modifiers.
Using the signature profiles of Anakin and Brd4, the inventors have
demonstrated that these genes predict survival outcome in affymetrix
and glass slide based microarray experiments. As a result, screening
for Brd4 and/or Anakin status in tumors could be an important
prognostic test and may enable physicians to better stratify patients
based on risk of recurrence and progression to metastatic disease.
Applications:
Detecting metastatic disease in patients diagnosed with
cancer.
Method of characterizing a tumor or cancer by detecting
the expression levels of Anakin or Brd4.
Diagnostic tool to aid clinicians in determining
appropriate cancer treatment.
Market:
Approximately 1,437,180 new cancer cases are expected to
be diagnosed in 2008.
Almost 565,650 people in the U.S. are expected to die of
cancer. This is more than 1,500 people a day.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Kent Hunter and Nigel Crawford (NCI).
Patent Status: U.S. Provisional Application No. 60/970,400 filed 06
Sep 2007 (HHS Reference No. E-093-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Whitney A. Hastings; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Metastasis Susceptibility Section of the Laboratory of Cancer Biology
and Genetics is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize Brd4 and/or RRP1B (Anakin) prognostic tests.
Please contact John D. Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
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.
[[Page 48216]]
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;
wongje@mail.nih.gov.
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
hewesj@mail.nih.gov 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.
Applications: Anti-tumor agent for gastric, colon, lung, breast,
ovarian and pancreatic tumors.
Development Status: The technology is currently in the pre-clinical
stage of development.
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;
madua@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Structural Biophysics Laboratory is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize Conjugates of Ligand, Linker, and
Cytotoxic Agent and Related Compositions and Methods of Use. Please
contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for
more information.
SH2 Domain Binding Inhibitors
Description of Technology: Signal transduction processes underlie
the transfer of extracellular information to the interior of the cell
and ultimately to the nucleus. A variety of signal transduction
processes are critical for normal cellular homeostasis, with protein-
tyrosine kinases (PTKs) playing central roles in many of these
pathways. Examples of such PTKs include the PDGF receptor, the FGF
receptor, the HGF receptor, members of the EGF receptor family, such as
the EGF receptor, erb-B2, erb-B3 and erb-B4, the src kinase family, Fak
kinase and the Jak kinase family. Protein-tyrosine phosphorylation that
results from the action of PTKs can modulate the activity of certain
target enzymes as well as facilitate the formation of specific multi-
protein signaling complexes through the actions of homologous protein
modules termed Src homology 2 (SH2) domains, which recognize specific
phosphotyrosyl containing sequences. A malfunction in this system
through tyrosine kinase overexpression and/or deregulation can be
manifested by various oncogenic and hyperproliferative disorders,
including cancers, inflammation, autoimmune disease, hyperproliferative
skin disorders, psoriasis and allergy/asthma, etc. The disclosed
compounds, e.g. peptides, preferably, macrocyclic peptides, are Grb2
SH2 domain signaling antagonists with enhanced binding affinity. The
claims of the current application are directed to compositions of
matter and methods of use which provide for the diagnosis, testing and
treatment of the aforementioned disease states.
Applications: For treatment of cancer, inflammation, autoimmune
diseases, hyperproliferative skin disorders, psoriasis and asthma.
Development Status: The technology is currently in an early pre-
clinical stage of development.
Inventors: Terrence R. Burke, Jr., et al. (NCI).
Patent Status:
U.S. Patent No. 6,977,241 issued 20 Dec 2005 (HHS
Reference No. E-262-2000/0-US-03).
U.S. Patent Application No. 10/517,717 filed 17 Mar 2005,
allowed (HHS Reference No. E-262-2000/1-US-03).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Adaku Nwachukwu, J.D.; 301-435-5560;
madua@mail.nih.gov.
Dated: August 7, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-18982 Filed 8-19-08; 8:45 am]
BILLING CODE 4140-01-P
