Government-Owned Inventions; Availability for Licensing, 10283-10285 [2010-4761]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
Licensing Contact: Betty B. Tong,
PhD; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Child Health
and Human Development, Reproductive
Biology and Adult Endocrinology
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize [131I]-MIBG treatment of
malignant/metastatic
pheochromocytoma, paraganglioma, and
neuroblastoma; also [123/131I]-MIBG
scintigraphy—in all situations histone
deacetylase to be used before MIBG is
used. Please contact Joseph Conrad, PhD
at 301–435–3107 or
jmconrad@mail.nih.gov for more
information.
erowe on DSK5CLS3C1PROD with NOTICES
Specific Binding Agents for KSHV vIL–
6 That Neutralize a Biological Activity
Description of Invention: Kaposi’s
sarcoma-associated herpes virus (KSHV)
is an oncogenic herpes virus originally
identified in AIDS associated Kaposi’s
sarcoma (KS) lesions, the most common
tumor associated with HIV infection.
KSHV encodes various proteins that
have characteristics associated with
cellular growth and transformation,
including viral (v) IL–6 (KSHV vIL–6).
These viral proteins display structural
homology to their cellular counterparts,
and human and vIL–6 are
multifunctional cytokines that have
been shown to induce vascular
endothelial growth factor and other
factors.
Available for licensing are binding
agents that neutralize vIL–6 biological
activities, methods of diagnosing and
treating KSHV disorders, and methods
to monitor KSHV patient response to
treatment. Deregulation of cellular IL–6
expression is known to contribute to
tumor development, suggesting that
KSHV-derived vIL–6 could be part of a
viral strategy to promote malignant
transformation. Neutralizing activity of
anti-vIL–6 antibodies may provide a
potential therapeutic for KSHV
disorders such as HIV, Castleman’s
disease, and primary effusion
lymphoma.
Applications:
• Therapeutic compositions to treat
KSHV disorders such as KS,
Castleman’s disease, and primary
effusion lymphoma.
• Method to diagnose and treat KSHV
disorders.
• Method to monitor patient response
to KSHV treatment.
Market:
VerDate Nov<24>2008
14:45 Mar 04, 2010
Jkt 220001
• Approximately 476,095 persons
currently living with HIV/AIDS in the
United States.
• Estimated annual incidence rate for
KS is 5 cases per 100,000/year in the
U.S.
• KS contributes to approximately
30% of AIDS related deaths.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Giovanna Tosato (NCI) et
al.
Publications:
1. Y Aoki and G Tosato. Therapeutic
options for human herpesvirus-8/
Kaposi’s sarcoma-associated
herpesvirus-related disorders. Expert
Rev Anti Ther. 2004 Apr;2(2):213–225.
[PubMed: 15482187].
2. Y Aoki et al. Detection of viral
interleukin-6 in Kaposi sarcomaassociated herpesvirus-linked disorders.
Blood. 2001 Apr 1;97(7):2173–2176.
[PubMed: 11264189].
3. Y Aoki et al. Kaposi’s sarcomaassociated herpesvirus-encoded
interleukin-6. J Hemathother Stem Cell
Res. 2000;9(2):137–145. [PubMed:
10813527].
Patent Status:
U.S. Patent No. 6,939,547 issued 06
Sep 2005 (HHS Reference No. E–180–
2000/0–US–03).
U.S. Patent No. 7,108,981 issued 19
Sep 2006 (HHS Reference No. E–180–
2000/0–US–04).
U.S. Patent No. 7,235,365 issued 26
Jun 2007 (HHS Reference No. E–180–
2000/0–US–05).
U.S. Patent No. 7,374,756 issued 20
May 2008 (HHS Reference No. E–180–
2000/0–US–06).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301/435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute’s
Laboratory of Cellular Oncology is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
therapeutics for Kaposi’s sarcomaassociated herpes virus (KSHV). Please
contact John D. Hewes, PhD at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Dated: March 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–4762 Filed 3–4–10; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
10283
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.
Patient-Derived Gastrointestinal
Stromal and Paraganglioma Tumor
Samples Harboring Novel Stem Cell
Factor FOXD3 Variants
Description of Invention: The cancer
market is forecast to reach $40 billion
dollars by the year 2012. There is still
a significant need to develop new
therapies for treating sarcomas and
malignant neoplasms.
Researchers at the National Institute
of Child Health and Human
Development (NICHD), NIH, have made
available samples of patient-derived
gastrointestinal tumors (GIST) and
paraganglioma tumors that harbor
genetic mutations that have an effect on
early stage embrogenesis which plays a
role in the fate of stem cells. GISTs are
one of the most common sarcomas of
the gastrointestinal tract with an
estimated 5,000–10,000 new cases in the
U.S. reported each year. GISTs affect
mainly pediatric and young adult
patients, and respond poorly to current
therapies. Paragangliomas are rare
neuroendocrine neoplasms that develop
primarily in the abdomen.
The tumor samples made available
herein contain deletions in the FOXD3
gene and display down-regulated
FOXD3 protein expression. While the
E:\FR\FM\05MRN1.SGM
05MRN1
10284
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
were tested and found to inhibit Akt
activity specifically through the PH
domain. Some of these compounds
demonstrated broad cytotoxicity to a
wide variety of tumor cells. These novel
Akt-inhibiting compositions target the
PH domain and help in the prevention
and treatment of cancer. Since it has
been shown that reducing the activity of
the PI3K–Akt pathway sensitizes
malignant cells to chemotherapy or
radiotherapy, these novel Akt inhibitors
have potential either as single anticancer agents or in combination with
conventional cancer therapies.
One of the candidate compounds
inhibited Colony Stimulating Factor-1
Receptor (CSF1R) from binding to ATP
but had no activity for other kinases.
CSF1R has been implicated in
development of cancers like chronic
myelomonocytic leukemia, but also in
Alzheimer’s disease so this specific
compound may have use in treating
other diseases in addition to cancer.
Applications:
• Treating or preventing development
of cancer or preventing progression of
premalignant lesions to cancer.
• Used as a single agent or in
combination with other anti-cancer
treatments like chemotherapy,
biological therapy, or radiation.
• Inhibiting the activity of CSF1R
receptor to treat diseases like chronic
myelomonocytic leukemia and
Alzheimer’s disease or an adverse
condition, such as brain injury.
Novel Kinase Inhibitors Targeting the
Advantages: Targeting the PH domain
PH Domain of AKT for Preventing and
improves specificity against Akt kinase
Treating Cancer
in comparison to inhibitors of the ATP
Description of Invention: Activation of domain which typically are unspecific.
the PI3K/Akt signaling pathway has
Inventors: Phillip A. Dennis (NCI) et
been implicated in the development of
al.
cancer. Akt, a kinase that is central to
Patent Status: U.S. Provisional
this pathway, is found at elevated levels
Application No. 61/226,328 filed 17 Jul
in many tumors and is associated with
a poor disease prognosis. Many research 2009 (HHS Reference No. E–212–2009/
0–US–01).
studies have validated Akt as a
therapeutic target for the development
Licensing Status: Available for
of anti-cancer drugs. Most efforts of drug licensing.
development targeting Akt have focused
Licensing Contact: Surekha Vathyam,
on inhibitors of the ATP-binding
PhD; 301–435–4076;
domain which tend to interfere with
vathyams@mail.nih.gov.
other physiologically important kinases.
Collaborative Research Opportunity:
An alternative strategy that has been
The Center for Cancer Research,
proposed to improve drug specificity is
Medical Oncology Branch and
the targeting of the unique pleckstrin
Affiliates, is seeking statements of
homology (PH) domain of Akt.
Investigators at the National Institutes capability or interest from parties
interested in collaborative research to
of Health have screened a library of
further develop, evaluate, or
small chemical compounds with drugcommercialize this technology. Please
like characteristics that likely bound to
contact John D. Hewes, PhD at 301–435–
the PH domain and have identified
several candidates previously unknown 3121 or hewesj@mail.nih.gov for more
information.
to interact with Akt. These compounds
erowe on DSK5CLS3C1PROD with NOTICES
majority of GISTs result from activating
mutations in the oncogene receptor
tyrosine kinases c-KIT and PDGFRA,
these tumor samples do not harbor
mutations in c-KIT or PDGFRA (‘‘nonKIT/ PDGFRA-GISTs’’) and respond
poorly to receptor tyrosine kinase
inhibitors.
Applications:
• Useful in the investigation of
inactivating genetic changes in FOXD3
in non-KIT/PDGFRA-GISTs.
• Useful in the study of new
molecules and/or pathways that may
serve as an appropriate therapeutic
target.
Inventors: Constantine Stratakis et al.
(NICHD).
Patent Status: HHS Reference No. E–
058–2010/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a biological material
license.
Licensing Contact: Patrick P. McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Child Health
and Human Development
Endocrinology & Genetics Section is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
technology. Please contact Joseph
Conrad, PhD at 301–435–3107 or
jmconrad@mail.nih.gov for more
information.
VerDate Nov<24>2008
14:45 Mar 04, 2010
Jkt 220001
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Diagnostic Biomarker of Metastasis for
Improved Clinical Management of Head
and Neck Cancer
Description of Invention: Squamous
Cell Carcinoma of the Head and Neck
(HNSCC) is associated with poor
prognosis due to the advanced stage of
disease (metastasis) typically found at
the time of diagnosis. Investigators at
the NIH have developed a sensitive
method using a protein biomarker for
detecting even just a few HNSCC tumor
cells in lymph nodes with occult
disease. Combination of this staging
technique with intraoperative sentinel
lymph node mapping would improve
the management of HNSCC by
identifying patients for which radical
lymph node dissection is most
appropriate, sparing those for which it
is not, and informing decisions for
adjuvant cancer therapy during a single
surgery.
This technology arose from the
discovery that the Desmoglein-3 (DSG3)
protein which is highly expressed in
tumors of squamous epithelial origin,
like HNSCC, is also expressed in
invaded lymph nodes but it is not found
in normal lymph nodes. Therefore,
DSG3 can serve as a biomarker for
detecting metastastatic spread of
squamous cell carcinoma tumors. This
is achieved by performing protein
detection immunoassays to samples
(biopsy, aspirate, or isolated cells) of
suspect lymph nodes.
Applications: Use with sentinel
lymph node mapping for rapid,
intraoperational diagnosis of metastatic
HNSCC for guiding proper therapeutic
approach.
Advantages:
• Rapid diagnosis during surgery
increases effectiveness of intervention
thereby reducing need for subsequent
surgery.
• Improved accuracy of direct
measurement of protein levels over RNA
assays.
• More robust assay as protein is
more stable than RNA.
Development Status:
• Early stage.
• Clinical data available.
Market: HNSCC is the sixth most
prevalent cancer among men worldwide
and is associated with poor prognosis,
which has improved only marginally
over the past three decades. This is
reflected by HNSCC being the eighth
leading cause of cancer death
worldwide.
Inventors: J. Silvio Gutkind et al.
(NIDCR).
Related Publication: Patel V, Hood
BL, Molinolo AA, Lee NH, Conrads TP,
Braisted JC, Krizman DB, Veenstra TD,
E:\FR\FM\05MRN1.SGM
05MRN1
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
Gutkind JS. Proteomic analysis of lasercaptured paraffin-embedded tissues: a
molecular portrait of head and neck
cancer progression. Clin Cancer Res.
2008 Feb 15;14(4)1002–1014. [PubMed:
18281532].
Patent Status: U.S. Provisional
Application No. 61/186,582 filed June 6,
2009 (HHS Reference No. E–300–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney Hastings,
PhD; 301–451–7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The NIDCR, OPCB, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the use of DSG3 as a
biomarker for detecting metastastatic
spread of squamous cell carcinoma
tumors. Please contact David W.
Bradley, PhD at
bradleyda@nidcr.nih.gov for more
information.
Dated: March 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–4761 Filed 3–4–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
erowe on DSK5CLS3C1PROD with NOTICES
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
VerDate Nov<24>2008
14:45 Mar 04, 2010
Jkt 220001
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Long Acting Ophthalmic Analgesic Eye
Drops
Description of Invention: This
invention is directed to the discovery
that resiniferatoxin (RTX) produces a
three to four day analgesic effect when
topically applied to the cornea. Efficacy
for RTX as an effective analgesic has
been demonstrated in vivo in rats.
Importantly, unlike currently available
analgesics, RTX left the blink reflex
intact and did not impact mechanical
sensitivity. RTX also did not impair
epithelial wound healing and
functioned without detectable damage
to the cornea.
RTX is a potent agonist of the
transient receptor potential channel,
subfamily V, member 1 (TRPV1). TRPV1
is involved in pain sensation and is
expressed only in select neurons. Unlike
other local analgesics that target a wide
breadth of neurons, RTX targets only
those neurons that express TRPV1,
leaving the important blink reflex and
mechanical sensitivity of the eye
unaffected.
Applications:
• An ophthalmic analgesic for postoperative eye pain.
• An ophthalmic analgesic for acute
or chronic eye injury.
• Applicable to both human and
veterinary patients.
Advantages:
• Both long lasting and reversible.
• Does not impair epithelial wound
healing, leaves the blink reflex intact,
and functions without detectable
damage to the cornea.
Development Status:
• Early stage.
• Demonstrated efficacy in vivo in
rats.
Market: Twenty-six million people
worldwide experience neuropathic
pain, resulting in healthcare costs of
over three billion dollars per year.
Inventors: Michael J. Iadarola,
Andrew J. Mannes, Jason M. Keller,
Kendall Mitchell, Brian D. Bates
(NIDCR).
Publication: In preparation.
Patent Status: U.S. Provisional
Application No. 61/247,881 filed 01 Oct
2009 (HHS Reference No. E–117–2009/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Charlene Sydnor,
PhD; 301–435–4689;
sydnorc@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Dental and
Craniofacial Research, Laboratory of
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
10285
Sensory Biology, Neurobiology and Pain
Therapeutics Section, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact David W. Bradley, PhD at 301–
402–0540 or bradleyda@nidcr.nih.gov
for more information.
Novel Compositions for Use as Bone
Scaffolds and Enhancers of Bone
Regeneration
Description of Invention: This
invention is directed to the discovery
that a mixture of an organic polymer
and inorganic particles may hold
therapeutic utility as a biomaterial for
artificial bone scaffolds, injectable bonefilling materials, and enhancement of
new bone generation. This composition
has demonstrated utility in vivo in
mice.
The inventors have discovered a
means of producing a stably
homogenous mixture of the organic
polymer and inorganic particles by
crosslinking the two components. In
contrast to current technologies, this
invention not only imparts sufficient
mechanical and load-bearing strength
but also provides a suitable
environment for new bone formation.
Importantly, since the chemical reaction
applied to make this biomaterial does
not produce any harmful molecules or
heat, it can be used in an injectable
form. Bone formation or replacement is
often a desired therapy for bone loss or
defects due to fractures or bone
degenerative diseases.
Applications:
• Injectable bone-filling materials.
• Artificial bone sponge for bone
defect.
• Artificial bone sponge for bone cell
culture in bone and mineralization
research.
Advantages:
• Combines bone-like strength and a
suitable environment for new bone
formation
• Injectable.
Development Status:
• Early stage.
• Tested in vivo in mice.
Market: According to
Freedoniagroup.com, the US orthopedic
implant market was $14.3 billion in
2007 and is expected to grow 8.9
percent annually through 2012. (https://
www.freedoniagroup.com/OrthopedicImplants.html, accessed December 2,
2009.)
Inventors: EunAh Lee and Pamela
Robey (NIDCR) et al.
Publication: In preparation.
Patent Status:
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10283-10285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4761]
-----------------------------------------------------------------------
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.
Patient-Derived Gastrointestinal Stromal and Paraganglioma Tumor
Samples Harboring Novel Stem Cell Factor FOXD3 Variants
Description of Invention: The cancer market is forecast to reach
$40 billion dollars by the year 2012. There is still a significant need
to develop new therapies for treating sarcomas and malignant neoplasms.
Researchers at the National Institute of Child Health and Human
Development (NICHD), NIH, have made available samples of patient-
derived gastrointestinal tumors (GIST) and paraganglioma tumors that
harbor genetic mutations that have an effect on early stage
embrogenesis which plays a role in the fate of stem cells. GISTs are
one of the most common sarcomas of the gastrointestinal tract with an
estimated 5,000-10,000 new cases in the U.S. reported each year. GISTs
affect mainly pediatric and young adult patients, and respond poorly to
current therapies. Paragangliomas are rare neuroendocrine neoplasms
that develop primarily in the abdomen.
The tumor samples made available herein contain deletions in the
FOXD3 gene and display down-regulated FOXD3 protein expression. While
the
[[Page 10284]]
majority of GISTs result from activating mutations in the oncogene
receptor tyrosine kinases c-KIT and PDGFRA, these tumor samples do not
harbor mutations in c-KIT or PDGFRA (``non-KIT/ PDGFRA-GISTs'') and
respond poorly to receptor tyrosine kinase inhibitors.
Applications:
Useful in the investigation of inactivating genetic
changes in FOXD3 in non-KIT/PDGFRA-GISTs.
Useful in the study of new molecules and/or pathways that
may serve as an appropriate therapeutic target.
Inventors: Constantine Stratakis et al. (NICHD).
Patent Status: HHS Reference No. E-058-2010/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing under a biological
material license.
Licensing Contact: Patrick P. McCue, PhD; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of Child
Health and Human Development Endocrinology & Genetics Section is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
this technology. Please contact Joseph Conrad, PhD at 301-435-3107 or
jmconrad@mail.nih.gov for more information.
Novel Kinase Inhibitors Targeting the PH Domain of AKT for Preventing
and Treating Cancer
Description of Invention: Activation of the PI3K/Akt signaling
pathway has been implicated in the development of cancer. Akt, a kinase
that is central to this pathway, is found at elevated levels in many
tumors and is associated with a poor disease prognosis. Many research
studies have validated Akt as a therapeutic target for the development
of anti-cancer drugs. Most efforts of drug development targeting Akt
have focused on inhibitors of the ATP-binding domain which tend to
interfere with other physiologically important kinases. An alternative
strategy that has been proposed to improve drug specificity is the
targeting of the unique pleckstrin homology (PH) domain of Akt.
Investigators at the National Institutes of Health have screened a
library of small chemical compounds with drug-like characteristics that
likely bound to the PH domain and have identified several candidates
previously unknown to interact with Akt. These compounds were tested
and found to inhibit Akt activity specifically through the PH domain.
Some of these compounds demonstrated broad cytotoxicity to a wide
variety of tumor cells. These novel Akt-inhibiting compositions target
the PH domain and help in the prevention and treatment of cancer. Since
it has been shown that reducing the activity of the PI3K-Akt pathway
sensitizes malignant cells to chemotherapy or radiotherapy, these novel
Akt inhibitors have potential either as single anti-cancer agents or in
combination with conventional cancer therapies.
One of the candidate compounds inhibited Colony Stimulating Factor-
1 Receptor (CSF1R) from binding to ATP but had no activity for other
kinases. CSF1R has been implicated in development of cancers like
chronic myelomonocytic leukemia, but also in Alzheimer's disease so
this specific compound may have use in treating other diseases in
addition to cancer.
Applications:
Treating or preventing development of cancer or preventing
progression of premalignant lesions to cancer.
Used as a single agent or in combination with other anti-
cancer treatments like chemotherapy, biological therapy, or radiation.
Inhibiting the activity of CSF1R receptor to treat
diseases like chronic myelomonocytic leukemia and Alzheimer's disease
or an adverse condition, such as brain injury.
Advantages: Targeting the PH domain improves specificity against
Akt kinase in comparison to inhibitors of the ATP domain which
typically are unspecific.
Inventors: Phillip A. Dennis (NCI) et al.
Patent Status: U.S. Provisional Application No. 61/226,328 filed 17
Jul 2009 (HHS Reference No. E-212-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Medical Oncology Branch and Affiliates, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact John D. Hewes, PhD at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Diagnostic Biomarker of Metastasis for Improved Clinical Management of
Head and Neck Cancer
Description of Invention: Squamous Cell Carcinoma of the Head and
Neck (HNSCC) is associated with poor prognosis due to the advanced
stage of disease (metastasis) typically found at the time of diagnosis.
Investigators at the NIH have developed a sensitive method using a
protein biomarker for detecting even just a few HNSCC tumor cells in
lymph nodes with occult disease. Combination of this staging technique
with intraoperative sentinel lymph node mapping would improve the
management of HNSCC by identifying patients for which radical lymph
node dissection is most appropriate, sparing those for which it is not,
and informing decisions for adjuvant cancer therapy during a single
surgery.
This technology arose from the discovery that the Desmoglein-3
(DSG3) protein which is highly expressed in tumors of squamous
epithelial origin, like HNSCC, is also expressed in invaded lymph nodes
but it is not found in normal lymph nodes. Therefore, DSG3 can serve as
a biomarker for detecting metastastatic spread of squamous cell
carcinoma tumors. This is achieved by performing protein detection
immunoassays to samples (biopsy, aspirate, or isolated cells) of
suspect lymph nodes.
Applications: Use with sentinel lymph node mapping for rapid,
intraoperational diagnosis of metastatic HNSCC for guiding proper
therapeutic approach.
Advantages:
Rapid diagnosis during surgery increases effectiveness of
intervention thereby reducing need for subsequent surgery.
Improved accuracy of direct measurement of protein levels
over RNA assays.
More robust assay as protein is more stable than RNA.
Development Status:
Early stage.
Clinical data available.
Market: HNSCC is the sixth most prevalent cancer among men
worldwide and is associated with poor prognosis, which has improved
only marginally over the past three decades. This is reflected by HNSCC
being the eighth leading cause of cancer death worldwide.
Inventors: J. Silvio Gutkind et al. (NIDCR).
Related Publication: Patel V, Hood BL, Molinolo AA, Lee NH, Conrads
TP, Braisted JC, Krizman DB, Veenstra TD,
[[Page 10285]]
Gutkind JS. Proteomic analysis of laser-captured paraffin-embedded
tissues: a molecular portrait of head and neck cancer progression. Clin
Cancer Res. 2008 Feb 15;14(4)1002-1014. [PubMed: 18281532].
Patent Status: U.S. Provisional Application No. 61/186,582 filed
June 6, 2009 (HHS Reference No. E-300-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Whitney Hastings, PhD; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The NIDCR, OPCB, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
the use of DSG3 as a biomarker for detecting metastastatic spread of
squamous cell carcinoma tumors. Please contact David W. Bradley, PhD at
bradleyda@nidcr.nih.gov for more information.
Dated: March 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-4761 Filed 3-4-10; 8:45 am]
BILLING CODE 4140-01-P
