Government-Owned Inventions; Availability for Licensing, 44267-44270 [2010-18487]
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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices
whether the information will have
practical utility; (2) evaluate the
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burden of the proposed collection of
information, including the validity of
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(3) enhance the quality, utility, and
clarity of the information to be
collected; and (4) minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
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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: Office
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OIRA_submission@omb.eop.gov or by
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Comments Due Date: Comments
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received within 30 days of the date of
this publication.
Dated: July 19, 2010.
Sally Lee,
Executive Officer, NIGMS, National Institute
of General Medical Sciences, National
Institutes of Health.
[FR Doc. 2010–18509 Filed 7–27–10; 8:45 am]
BILLING CODE 4140–01–P
Food and Drug Administration
sroberts on DSKD5P82C1PROD with NOTICES
[Docket No. FDA–2009–N–0495]
Draft Guidance for Industry and Food
and Drug Administration Staff; Medical
Devices; Neurological and Physical
Medicine Device Guidance Document;
Reopening of Comment Period
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening until
SUMMARY:
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Submit either electronic or
written comments by September 7,
2010.
DATES:
Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
ADDRESSES:
III. How to Submit Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: July 22, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–18406 Filed 7–27–10; 8:45 am]
BILLING CODE 4160–01–S
FOR FURTHER INFORMATION CONTACT:
Robert J. DeLuca, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G214, Silver Spring,
MD 20993–0002, e-mail:
Robert.DeLuca@fda.hhs.gov, 301–796–
6630.
In the Federal Register of April 5,
2010 (75 FR 17093), FDA published a
notice announcing the availability of
draft special controls guidance
documents for 11 neurological and
physical medicine devices. Interested
persons were originally given until July
6, 2010, to comment on the draft
guidance documents. The agency
expressed specific interest in comments
on the types of claims appropriate for
devices included within the 11
classifications and, for devices that
remain subject to premarket review, the
data sponsors should submit to support
those claims.
Following publication of the April 5,
2010, notice, FDA received requests to
allow interested persons additional time
to comment. The requests asserted that
the 90-day time period was insufficient
to respond fully to FDA’s specific
requests for comments and to allow
potential respondents to thoroughly
evaluate and address pertinent issues.
The agency has considered the requests
and is reopening the comment period
until September 7, 2010. The agency
believes the additional comment period
allows adequate time for interested
persons to submit comments without
significantly delaying rulemaking on
these important issues.
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National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
I. Background
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
SUPPLEMENTARY INFORMATION:
II. Request for Comments
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
September 7, 2010, the comment period
for the notice that appeared in the
Federal Register of April 5, 2010 (75 FR
17143). In the notice, FDA requested
comments on draft guidance documents
for 11 neurological and physical
medicine devices. FDA is reopening the
comment period to allow further
comment and to receive any new
information.
44267
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.
SUMMARY:
Software System With Applications in
Clinical Prognosis, Personalized
Medicine and Clinical Research
Description of Invention: Available for
licensing is software that can provide
prognostic information for different
diseases and in particular for cancer.
The software can determine whether a
particular genotype has a significant
association with survival time for an
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individual receiving treatment. For
example, it can determine if a specific
genetic pattern is associated with an
increased or decreased time to
recurrence of a particular type of cancer
for patients on a given treatment
regimen.
Applications:
• Applications in clinical research:
—Studying relationship between
genotypes and survival times.
—Evaluation of treatment regimens.
• Applications in drug discovery
programs.
• Clinical prognosis.
• Personalized medicine.
Development Status:
• The invention has been fully
developed.
• The software will be readily
available in executable form if so
requested.
Inventor: Brian T. Luke (SAIC/NCI).
Patent Status: HHS Reference No. E–
182–2010/0—Software. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
Licensing Contacts:
• Uri Reichman, PhD, MBA; 301–
435–4616; UR7a@nih.gov.
• Michael Shmilovich, Esq.; 301–
435–5019; shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NCI is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact John Hewes, PhD, at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
sroberts on DSKD5P82C1PROD with NOTICES
Software for Accurate Segmentation of
Cell Nuclei in Breast Tissue
Description of Invention: Automatic
segmentation of cell nuclei is critical in
several high-throughput cytometry and
pathology applications (1), such as
spatial analysis of genetic loci by
fluorescence in situ hybridization
(‘‘FISH’’), whereas manual segmentation
is laborious (2). Current automated
segmentation methods have varying
performance in the presence of
distortions introduced during sample
preparation, non-uniform illumination,
clustering of the individual objects of
interest (cells or cell nuclei), and
seldom assess boundary accuracy.
Researchers at the National Cancer
Institute-Frederick, NIH, have
developed an automatic algorithm to
segment cell nuclei (3) and FISH signals
from two-dimensional images of breast
tissue. This automated system integrates
a series of advanced image processing
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methods to overcome the delays
inherent to current manual methods for
segmenting (delineating) individual cell
nuclei in tissue samples. The system
automatically selects a subset of nuclei
that with high likelihood are accurately
segmented. This system has been
validated using both simulated and
actual datasets that have been accurately
analyzed by manual methods. The
system generalizes to independent
analysis of many spatial parameters
useful for studying spatial gene
positioning in interphase nuclei, and
potentially has a wide range of
diagnostic pathology, cytological and
high throughput screening applications.
Applications:
• Investigations on genomic
organization (nuclear architecture and
non-random gene positioning) in the
individual nuclei in tissues.
• Other pathology and cytological
and high throughput screening
applications requiring precise,
quantitative analysis of a subset of cell
nuclei in the sample.
Advantages:
• Automatic.
• Efficient, robust and effective in
extracting individual nuclei with FISH
labels.
• Facilitates reproducible and
unbiased spatial analysis of DNA
sequences in interphase nuclei.
Development Status:
• Early stage.
• Negotiations are underway with
several companies to scale up
development of the system and to
undertake pre-clinical validation for
gene positioning in the nuclei of breast
sections as a possible early-stage
diagnostic or prognostic test for cancer.
Inventors: Kaustav Nandy et al. (NCI).
Related Publications:
1. Gudla PR, Nandy K, Collins J,
Meaburn KJ, Misteli T, Lockett SJ. A
high-throughput system for segmenting
nuclei using multiscale techniques.
Cytometry A. 2008 May;73(5):451–466.
[PubMed: 18338778].
2. Meaburn KJ, Gulda PR, Khan S,
Lockett SJ, Misteli T. Disease-specific
gene repositioning in breast cancer. J
Cell Biol. 2009 Dec 14;187(6):801–812.
[PubMed: 19995938].
3. Nandy K, Gudla PR, Meaburn KJ,
Misteli T, Lockett SJ. Automatic nuclei
segmentation and spatial FISH analysis
for cancer detection. Conf Proc IEEE Eng
Med Biol Soc 2009;2009:6718–6721.
[PubMed: 19963931].
Patent Status: HHS Reference No. E–
106–2010/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
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Licensing Contact: Patrick P. McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The inventers, working for the Office of
the Director, National Cancer Institute,
are seeking statements of capability or
interest from parties interested in
collaborative research (using the
Cooperative Research and Development
Agreement (CRADA) or Material
Transfer Agreement (MTA)) to further
develop, evaluate, or commercialize the
software for accurate segmentation of
cell nuclei and FISH signals in tissue
sections. Collaborators working in the
field of quantitative and automated
pathology may be interested. Please
contact John Hewes, PhD, at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Use of Cucurbitacins and Withanolides
for the Treatment of Cancer
Description of Invention: Certain
members of the cucurbitacin and
Withanolide family have been identified
that can sensitize some tumor cell lines
to cell death (apoptosis) on subsequent
exposure of the cells to pro-apoptotic
receptor agonists (PARAS) of the TRAIL
‘‘death receptors’’. These PARAS include
TRAIL itself, and agonist antibodies to
two of its receptors death receptor-4
(DR4 or TRAIL–R1) and death receptor
5 (DR5, TRAIL–R2).
The protein TRAIL has a very
interesting characteristic that it can
preferentially cause death of cancer
cells whereas normal non-transformed
cells are unaffected. Thus use of TRAIL
or agonist antibodies to its so-called
‘‘death receptors’’ has been a current
focus in cancer therapy.
Applications:
• Use of the compounds with known
TRAIL or agonist antibodies such as
Mapatumumab (currently being
developed by Human Genome
Sciences).
• Use of the compounds in
combination with immunotherapeutic
approaches for the treatment of cancer.
Advantages: CUCURBITACINS AND
WITHANOLIDES can be successfully
developed in combination with known
TRAIL agonist have the potential of new
cancer combination therapies without
major toxicities.
Development Status: In vivo studies
are ongoing.
Inventors: Thomas J. Sayers et al.
(NCI).
Publication: NL Booth et al. A cellbased high-throughput screen to
identify synergistic TRAIL sensitizers.
Cancer Immunol Immunother. 2009
Aug;58(8):1229–1244. [PubMed:
19089423].
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Patent Status: U.S. Provisional
Application No. 61/287,139 filed 16 Dec
2009 (HHS Reference No. E–050–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Sabarni Chatterjee,
PhD; 301–435–5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Laboratory of Experimental
Immunology, Cancer Inflammation
Program, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the use of certain
cucurbatacins or withanolides in
combination with pro-apoptotic agonists
of TRAIL death receptors for cancer
therapy. Please contact John Hewes,
PhD, at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Nitroxyl (HNO) Releasing Compounds
and Uses Thereof in Treating Diseases
Description of Invention: This
technology discloses HNO releasing
compounds and methods of treating
various diseases with such compounds.
HNO has recently emerged as a
prospective pharmacological agent.
Studies of the chemistry of HNO have
led to an understanding that HNO is
vastly different from nitric oxide (NO),
the one-electron oxidation product of
HNO. HNO displays unique
cardiovascular properties and has been
shown to have positive effects in failing
hearts without changing heart rate. HNO
has also been shown to have beneficial
effects in ischemia reperfusion injury. In
addition to the cardiovascular effects
observed, HNO has shown initial
promise in the realm of cancer therapy.
HNO has been demonstrated to inhibit
a key glycolytic enzyme. Due to the
Warburg effect, inhibiting glycolysis is
an attractive target for inhibiting tumor
proliferation. HNO has recently been
shown to inhibit tumor proliferation in
mouse xenografts. Additionally, HNO
inhibits tumor angiogenesis and induces
cancer cell apoptosis.
Applications:
• Potential treatment for
cardiovascular disease, ischemia, and
cancer.
• Tool to probe the role of HNO in
normal physiology and disease states.
Inventors: Larry K. Keefer (NCI).
Related Publications:
1. CH Switzer, et al. The emergence of
nitroxyl (HNO) as a pharmacological
agent. Biochim Biophys Acta 2009
Jul;1787(7):835–840. [PubMed:
19426703].
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2. LK Keefer. Nitric oxide (NO)- and
nitroxyl (HNO)-generating
diazeniumdiolates (NONOates):
emerging commercial opportunities.
Curr Top Med Chem. 2005;5(7):625–
636. [PubMed: 16101424].
Patent Status: U.S. Provisional
Application No. 61/315,604 filed 19 Mar
2010 (HHS Reference No. E–019–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Steve Standley,
PhD; 301–435–4074; sstand@od.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Laboratory of Comparative
Carcinogenesis, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize agents that generate HNO
in physiological media for therapeutic
benefit. Please contact John Hewes,
PhD, at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Prolonging Survival in Melanoma
Patients: Early Stage Diagnosis and
Treatment by Detecting and Inhibiting
NUAK2 Overexpression
Description of Invention: Melanoma
accounts for only 4% of skin cancers,
but is responsible for over 75% of skin
cancer deaths worldwide. There are few
treatment options available for
melanoma and all current options show
limited effectiveness. Melanoma is most
treatable in its early stages, but most
cases are not identified until the disease
has progressed to the point where
treatment is less effective. As normal
melanocytes transform into melanoma
tumor cells and metastasize, many
changes occur in their gene expression
patterns. Identifying genes whose
expression levels impact melanoma
patient survival is a key factor in
developing better early detection tests
and more effective treatment modalities
for the disease.
NUAK2 is a stress-activated kinase
and a member of the SNF–1/AMPK
kinase family, a conserved family of
serine/threonine kinases ubiquitous to
all eukaryotes. This enzyme is normally
involved in helping cells cope with
glucose starvation, promoting cell-cell
detachment for motility, and protecting
cells from CD95-mediated apoptosis.
SNF–1/AMPK kinases, such as NUAK2,
also regulate cell cycle machinery by
influencing the function of cyclindependent kinases (CDKs), such as
CDK2. When deregulated, SNF–1/
AMPK family members are known to
contribute to cancer development and
tumor progression in various cancers.
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44269
Scientists at the National Institutes of
Health (NIH) have identified the NUAK2
gene (also known as SNARK) as a factor
to predict the clinical outcome for
melanoma patients. NUAK2 was
selected as a gene of interest through
extensive analysis of over 120 primary
melanomas using a microarray-based
comparative genomic hybridization
approach which showed that genetic
aberrations in NUAK2 correlated with
disease. The most prominent discovery
was that gain at the NUAK2 locus and
deletion at the PTEN locus strongly
correlated with more severe acral
melanoma. Overexpression of phosphoAkt (p-Akt), caused by the PTEN
deletion, combined with the
overexpression of NUAK2 were found to
be associated with rapid disease
progression, poor patient survival, and
increased tumor thickness, especially in
acral melanoma models. The scientists
are developing diagnostic tests for
NUAK2 to better detect melanomas at an
early stage when the disease is most
treatable. They are also developing
therapeutic small hairpin RNAs
(shRNAs) to inhibit NUAK2 gene
expression and thereby reduce
melanoma tumor thickness and prevent
aggressive disease progression. The
shRNAs utilized to silence these target
genes are incorporated into lentiviral
vectors, which have the potential to be
delivered into humans. These scientists
also observed that NUAK2
overexpression correlated with
increased expression of various CDKs.
So, they are testing the effectiveness of
CDK inhibitors in targeting melanomas
that specifically exhibit genetic
aberrations in NUAK2 and PTEN
leading to NUAK2 and p-Akt
overexpression. These new potential
diagnostics and therapeutics centered
on NUAK2 could provide important
pharmaceutical tools to detect and treat
melanoma at various stages of disease.
Applications:
• Diagnostic tools and kits to identify
melanoma at an early stage of disease
where treatments are more effective and
the mortality rate is reduced. Diagnostic
tests for NUAK2 expression may be
most useful in detecting acral
melanoma, which is one of the most
prominent forms of melanoma in
Hispanic, Asian, and African-American
populations.
• Therapeutic nucleic acids to inhibit
melanoma disease progression by
targeting specific genes important in
poor clinical outcomes, such as NUAK2
and PTEN.
Advantages:
• Genetic aberrations in the NUAK2
and PTEN genes show a high correlation
with poor clinical outcomes in
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melanoma patients. Diagnostic tests
specifically directed at NUAK2 are
anticipated to be highly predictive of
the aggression level and course of
disease in individual patients. Gaining
information about melanoma before
late-stage symptoms are observed
should give clinicians more opportunity
to treat patients before the cancer
metastasizes out of control.
• Few therapies exist for melanoma
and the treatments utilized by clinicians
are prone to toxic side effects. Targeted
therapies, such as shRNAs directed
against NUAK2 could combine more
effective inhibition of melanoma with
fewer harsh side effects.
Development Status: This technology
is in a preclinical stage of development.
Market: There remains a long-felt
public health need to develop new
therapeutics and diagnostics for treating
melanoma. Melanoma is the most
serious type of skin cancer, accounting
the majority of skin cancer deaths, and
the percentage of people who develop
melanoma has more than doubled in the
past 30 years. With the increase in
Hispanic and Asian populations in the
United States, the incidence of acral
melanoma has risen to become a major
public health problem as it accounts for
between 30%–70% of melanoma cases
in dark-skinned individuals. In the
United States alone in 2009, it is
estimated that 68,720 new cases of
melanoma were diagnosed and 8,650
people were expected to die of the
disease. In 2005, the American
Academy of Dermatology and the
Society for Investigative Dermatology
released a comprehensive study that
quantified the estimated total direct cost
associated with the treatment of
melanoma in 2004 at $291 million in
the United States. Currently, there are
more than 200 therapeutics in active
development to target melanoma—from
early pre-clinical to marketed drugs.
Clearly, a sizable portion of the
melanoma diagnostic and therapeutic
markets is available, since no one course
of treatment is effective for all patients
and very few diagnostic tools exist to
identify melanoma at early stages.
Inventors: Vincent J. Hearing (NCI)
and Takeshi Namiki (formerly NCI).
Publications:
1. T Namiki, et al. Genomic
alterations in primary cutaneous
melanomas detected by metaphase
comparative genomic hybridization
with laser capture or manual
microdissection: 6p gains may predict
poor outcome. Cancer Genet Cytogenet.
2005 Feb;157(1):1–11. [PubMed:
15676140].
2. JH Kim, et al. SNARK, a novel
downstream molecule of EBV latent
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membrane protein 1, is associated with
resistance to cancer cell death. Leuk
Lymphoma. 2008 Jul;49(7):1392–1398.
[PubMed: 18452098].
Patent Status: U.S. Provisional
Application No. 61/321,136 filed 05
April 2010 (HHS Reference No. E–281–
2009/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Samuel E. Bish,
PhD; 301–435–5282;
bishse@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Laboratory of Cell Biology, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize Prolonging Survival in
Melanoma Patients. Please contact John
Hewes, PhD, at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Immortalized Human Bronchial
Epithelial Cell Line
Description of Invention: Normal cells
can be cultured in vitro for a limited
period of time before they exhibit a
‘‘crisis’’ or senescence, wherein they
display abnormal cell morphology and
significant reduction or cessation of cell
proliferation. Investigators at the
National Cancer Institute developed
immortalized cell line by isolating
bronchial epithelial cells from noncancerous individuals and subsequent
infection with an adenovirus 12–SV40
virus hybrid. Unlike normal cells, the
immortalized cells be cultured
continuously in vitro in suitable
medium and retain features of normal
human bronchial epithelial cells,
including the absence of invasive
behavior in vitro or in vivo. These cells
can also be transfected with oncogenes
and used as a model for multistage
carcinogenesis, or employed to assay a
biological or chemical agent’s ability to
induce differentiation and
carcinogenesis as well as test potential
chemotherapeutic agents.
Applications:
• Model to study multistage bronchial
carcinogenesis.
• Identification of potential
chemotherapeutic drugs.
• Identification of carcinogenic
agents.
Advantages: Immortalized cells that
retain normal human bronchial
characteristics.
Market:
• Global cancer market is worth more
than eight percent of total global
pharmaceutical sales.
• Cancer industry is predicted to
expand to $85.3 billion by 2010.
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Inventors: Curtis C. Harris (NCI) et al.
Relevant Publication: RR Reddel et al.
Transformation of human bronchial
epithelial cells by infection with SV40
or adenovirus-12 SV40 hybrid virus, or
transfection via stronium phosphate
coprecipitation with a plasmid
containing SV40 early region genes.
Cancer Res. 1988 Apr 1;48(7):1904–
1909. [PubMed: 2450641].
Patent Status: HHS Reference No. E–
287–1987/0—Research Material. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Laboratory of Human Carcinogenesis, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
Immortalized Human Bronchial
Epithelial Cell Line. Please contact John
Hewes, PhD, at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: July 22, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–18487 Filed 7–27–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
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]]>Agencies
[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Pages 44267-44270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18487]
-----------------------------------------------------------------------
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.
Software System With Applications in Clinical Prognosis, Personalized
Medicine and Clinical Research
Description of Invention: Available for licensing is software that
can provide prognostic information for different diseases and in
particular for cancer. The software can determine whether a particular
genotype has a significant association with survival time for an
[[Page 44268]]
individual receiving treatment. For example, it can determine if a
specific genetic pattern is associated with an increased or decreased
time to recurrence of a particular type of cancer for patients on a
given treatment regimen.
Applications:
Applications in clinical research:
--Studying relationship between genotypes and survival times.
--Evaluation of treatment regimens.
Applications in drug discovery programs.
Clinical prognosis.
Personalized medicine.
Development Status:
The invention has been fully developed.
The software will be readily available in executable form
if so requested.
Inventor: Brian T. Luke (SAIC/NCI).
Patent Status: HHS Reference No. E-182-2010/0--Software. Patent
protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contacts:
Uri Reichman, PhD, MBA; 301-435-4616; UR7a@nih.gov.
Michael Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The NCI is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact John Hewes, PhD, at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Software for Accurate Segmentation of Cell Nuclei in Breast Tissue
Description of Invention: Automatic segmentation of cell nuclei is
critical in several high-throughput cytometry and pathology
applications (1), such as spatial analysis of genetic loci by
fluorescence in situ hybridization (``FISH''), whereas manual
segmentation is laborious (2). Current automated segmentation methods
have varying performance in the presence of distortions introduced
during sample preparation, non-uniform illumination, clustering of the
individual objects of interest (cells or cell nuclei), and seldom
assess boundary accuracy.
Researchers at the National Cancer Institute-Frederick, NIH, have
developed an automatic algorithm to segment cell nuclei (3) and FISH
signals from two-dimensional images of breast tissue. This automated
system integrates a series of advanced image processing methods to
overcome the delays inherent to current manual methods for segmenting
(delineating) individual cell nuclei in tissue samples. The system
automatically selects a subset of nuclei that with high likelihood are
accurately segmented. This system has been validated using both
simulated and actual datasets that have been accurately analyzed by
manual methods. The system generalizes to independent analysis of many
spatial parameters useful for studying spatial gene positioning in
interphase nuclei, and potentially has a wide range of diagnostic
pathology, cytological and high throughput screening applications.
Applications:
Investigations on genomic organization (nuclear
architecture and non-random gene positioning) in the individual nuclei
in tissues.
Other pathology and cytological and high throughput
screening applications requiring precise, quantitative analysis of a
subset of cell nuclei in the sample.
Advantages:
Automatic.
Efficient, robust and effective in extracting individual
nuclei with FISH labels.
Facilitates reproducible and unbiased spatial analysis of
DNA sequences in interphase nuclei.
Development Status:
Early stage.
Negotiations are underway with several companies to scale
up development of the system and to undertake pre-clinical validation
for gene positioning in the nuclei of breast sections as a possible
early-stage diagnostic or prognostic test for cancer.
Inventors: Kaustav Nandy et al. (NCI).
Related Publications:
1. Gudla PR, Nandy K, Collins J, Meaburn KJ, Misteli T, Lockett SJ.
A high-throughput system for segmenting nuclei using multiscale
techniques. Cytometry A. 2008 May;73(5):451-466. [PubMed: 18338778].
2. Meaburn KJ, Gulda PR, Khan S, Lockett SJ, Misteli T. Disease-
specific gene repositioning in breast cancer. J Cell Biol. 2009 Dec
14;187(6):801-812. [PubMed: 19995938].
3. Nandy K, Gudla PR, Meaburn KJ, Misteli T, Lockett SJ. Automatic
nuclei segmentation and spatial FISH analysis for cancer detection.
Conf Proc IEEE Eng Med Biol Soc 2009;2009:6718-6721. [PubMed:
19963931].
Patent Status: HHS Reference No. E-106-2010/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contact: Patrick P. McCue, PhD; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The inventers, working for the
Office of the Director, National Cancer Institute, are seeking
statements of capability or interest from parties interested in
collaborative research (using the Cooperative Research and Development
Agreement (CRADA) or Material Transfer Agreement (MTA)) to further
develop, evaluate, or commercialize the software for accurate
segmentation of cell nuclei and FISH signals in tissue sections.
Collaborators working in the field of quantitative and automated
pathology may be interested. Please contact John Hewes, PhD, at 301-
435-3121 or hewesj@mail.nih.gov for more information.
Use of Cucurbitacins and Withanolides for the Treatment of Cancer
Description of Invention: Certain members of the cucurbitacin and
Withanolide family have been identified that can sensitize some tumor
cell lines to cell death (apoptosis) on subsequent exposure of the
cells to pro-apoptotic receptor agonists (PARAS) of the TRAIL ``death
receptors''. These PARAS include TRAIL itself, and agonist antibodies
to two of its receptors death receptor-4 (DR4 or TRAIL-R1) and death
receptor 5 (DR5, TRAIL-R2).
The protein TRAIL has a very interesting characteristic that it can
preferentially cause death of cancer cells whereas normal non-
transformed cells are unaffected. Thus use of TRAIL or agonist
antibodies to its so-called ``death receptors'' has been a current
focus in cancer therapy.
Applications:
Use of the compounds with known TRAIL or agonist
antibodies such as Mapatumumab (currently being developed by Human
Genome Sciences).
Use of the compounds in combination with immunotherapeutic
approaches for the treatment of cancer.
Advantages: CUCURBITACINS AND WITHANOLIDES can be successfully
developed in combination with known TRAIL agonist have the potential of
new cancer combination therapies without major toxicities.
Development Status: In vivo studies are ongoing.
Inventors: Thomas J. Sayers et al. (NCI).
Publication: NL Booth et al. A cell-based high-throughput screen to
identify synergistic TRAIL sensitizers. Cancer Immunol Immunother. 2009
Aug;58(8):1229-1244. [PubMed: 19089423].
[[Page 44269]]
Patent Status: U.S. Provisional Application No. 61/287,139 filed 16
Dec 2009 (HHS Reference No. E-050-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Sabarni Chatterjee, PhD; 301-435-5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Laboratory of Experimental Immunology, Cancer Inflammation Program, is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
the use of certain cucurbatacins or withanolides in combination with
pro-apoptotic agonists of TRAIL death receptors for cancer therapy.
Please contact John Hewes, PhD, at 301-435-3121 or hewesj@mail.nih.gov
for more information.
Nitroxyl (HNO) Releasing Compounds and Uses Thereof in Treating
Diseases
Description of Invention: This technology discloses HNO releasing
compounds and methods of treating various diseases with such compounds.
HNO has recently emerged as a prospective pharmacological agent.
Studies of the chemistry of HNO have led to an understanding that HNO
is vastly different from nitric oxide (NO), the one-electron oxidation
product of HNO. HNO displays unique cardiovascular properties and has
been shown to have positive effects in failing hearts without changing
heart rate. HNO has also been shown to have beneficial effects in
ischemia reperfusion injury. In addition to the cardiovascular effects
observed, HNO has shown initial promise in the realm of cancer therapy.
HNO has been demonstrated to inhibit a key glycolytic enzyme. Due to
the Warburg effect, inhibiting glycolysis is an attractive target for
inhibiting tumor proliferation. HNO has recently been shown to inhibit
tumor proliferation in mouse xenografts. Additionally, HNO inhibits
tumor angiogenesis and induces cancer cell apoptosis.
Applications:
Potential treatment for cardiovascular disease, ischemia,
and cancer.
Tool to probe the role of HNO in normal physiology and
disease states.
Inventors: Larry K. Keefer (NCI).
Related Publications:
1. CH Switzer, et al. The emergence of nitroxyl (HNO) as a
pharmacological agent. Biochim Biophys Acta 2009 Jul;1787(7):835-840.
[PubMed: 19426703].
2. LK Keefer. Nitric oxide (NO)- and nitroxyl (HNO)-generating
diazeniumdiolates (NONOates): emerging commercial opportunities. Curr
Top Med Chem. 2005;5(7):625-636. [PubMed: 16101424].
Patent Status: U.S. Provisional Application No. 61/315,604 filed 19
Mar 2010 (HHS Reference No. E-019-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Steve Standley, PhD; 301-435-4074;
sstand@od.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Laboratory of Comparative Carcinogenesis, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize agents that
generate HNO in physiological media for therapeutic benefit. Please
contact John Hewes, PhD, at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Prolonging Survival in Melanoma Patients: Early Stage Diagnosis and
Treatment by Detecting and Inhibiting NUAK2 Overexpression
Description of Invention: Melanoma accounts for only 4% of skin
cancers, but is responsible for over 75% of skin cancer deaths
worldwide. There are few treatment options available for melanoma and
all current options show limited effectiveness. Melanoma is most
treatable in its early stages, but most cases are not identified until
the disease has progressed to the point where treatment is less
effective. As normal melanocytes transform into melanoma tumor cells
and metastasize, many changes occur in their gene expression patterns.
Identifying genes whose expression levels impact melanoma patient
survival is a key factor in developing better early detection tests and
more effective treatment modalities for the disease.
NUAK2 is a stress-activated kinase and a member of the SNF-1/AMPK
kinase family, a conserved family of serine/threonine kinases
ubiquitous to all eukaryotes. This enzyme is normally involved in
helping cells cope with glucose starvation, promoting cell-cell
detachment for motility, and protecting cells from CD95-mediated
apoptosis. SNF-1/AMPK kinases, such as NUAK2, also regulate cell cycle
machinery by influencing the function of cyclin-dependent kinases
(CDKs), such as CDK2. When deregulated, SNF-1/AMPK family members are
known to contribute to cancer development and tumor progression in
various cancers.
Scientists at the National Institutes of Health (NIH) have
identified the NUAK2 gene (also known as SNARK) as a factor to predict
the clinical outcome for melanoma patients. NUAK2 was selected as a
gene of interest through extensive analysis of over 120 primary
melanomas using a microarray-based comparative genomic hybridization
approach which showed that genetic aberrations in NUAK2 correlated with
disease. The most prominent discovery was that gain at the NUAK2 locus
and deletion at the PTEN locus strongly correlated with more severe
acral melanoma. Overexpression of phospho-Akt (p-Akt), caused by the
PTEN deletion, combined with the overexpression of NUAK2 were found to
be associated with rapid disease progression, poor patient survival,
and increased tumor thickness, especially in acral melanoma models. The
scientists are developing diagnostic tests for NUAK2 to better detect
melanomas at an early stage when the disease is most treatable. They
are also developing therapeutic small hairpin RNAs (shRNAs) to inhibit
NUAK2 gene expression and thereby reduce melanoma tumor thickness and
prevent aggressive disease progression. The shRNAs utilized to silence
these target genes are incorporated into lentiviral vectors, which have
the potential to be delivered into humans. These scientists also
observed that NUAK2 overexpression correlated with increased expression
of various CDKs. So, they are testing the effectiveness of CDK
inhibitors in targeting melanomas that specifically exhibit genetic
aberrations in NUAK2 and PTEN leading to NUAK2 and p-Akt
overexpression. These new potential diagnostics and therapeutics
centered on NUAK2 could provide important pharmaceutical tools to
detect and treat melanoma at various stages of disease.
Applications:
Diagnostic tools and kits to identify melanoma at an early
stage of disease where treatments are more effective and the mortality
rate is reduced. Diagnostic tests for NUAK2 expression may be most
useful in detecting acral melanoma, which is one of the most prominent
forms of melanoma in Hispanic, Asian, and African-American populations.
Therapeutic nucleic acids to inhibit melanoma disease
progression by targeting specific genes important in poor clinical
outcomes, such as NUAK2 and PTEN.
Advantages:
Genetic aberrations in the NUAK2 and PTEN genes show a
high correlation with poor clinical outcomes in
[[Page 44270]]
melanoma patients. Diagnostic tests specifically directed at NUAK2 are
anticipated to be highly predictive of the aggression level and course
of disease in individual patients. Gaining information about melanoma
before late-stage symptoms are observed should give clinicians more
opportunity to treat patients before the cancer metastasizes out of
control.
Few therapies exist for melanoma and the treatments
utilized by clinicians are prone to toxic side effects. Targeted
therapies, such as shRNAs directed against NUAK2 could combine more
effective inhibition of melanoma with fewer harsh side effects.
Development Status: This technology is in a preclinical stage of
development.
Market: There remains a long-felt public health need to develop new
therapeutics and diagnostics for treating melanoma. Melanoma is the
most serious type of skin cancer, accounting the majority of skin
cancer deaths, and the percentage of people who develop melanoma has
more than doubled in the past 30 years. With the increase in Hispanic
and Asian populations in the United States, the incidence of acral
melanoma has risen to become a major public health problem as it
accounts for between 30%-70% of melanoma cases in dark-skinned
individuals. In the United States alone in 2009, it is estimated that
68,720 new cases of melanoma were diagnosed and 8,650 people were
expected to die of the disease. In 2005, the American Academy of
Dermatology and the Society for Investigative Dermatology released a
comprehensive study that quantified the estimated total direct cost
associated with the treatment of melanoma in 2004 at $291 million in
the United States. Currently, there are more than 200 therapeutics in
active development to target melanoma--from early pre-clinical to
marketed drugs. Clearly, a sizable portion of the melanoma diagnostic
and therapeutic markets is available, since no one course of treatment
is effective for all patients and very few diagnostic tools exist to
identify melanoma at early stages.
Inventors: Vincent J. Hearing (NCI) and Takeshi Namiki (formerly
NCI).
Publications:
1. T Namiki, et al. Genomic alterations in primary cutaneous
melanomas detected by metaphase comparative genomic hybridization with
laser capture or manual microdissection: 6p gains may predict poor
outcome. Cancer Genet Cytogenet. 2005 Feb;157(1):1-11. [PubMed:
15676140].
2. JH Kim, et al. SNARK, a novel downstream molecule of EBV latent
membrane protein 1, is associated with resistance to cancer cell death.
Leuk Lymphoma. 2008 Jul;49(7):1392-1398. [PubMed: 18452098].
Patent Status: U.S. Provisional Application No. 61/321,136 filed 05
April 2010 (HHS Reference No. E-281-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Samuel E. Bish, PhD; 301-435-5282;
bishse@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Laboratory of Cell Biology, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize Prolonging Survival in Melanoma
Patients. Please contact John Hewes, PhD, at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Immortalized Human Bronchial Epithelial Cell Line
Description of Invention: Normal cells can be cultured in vitro for
a limited period of time before they exhibit a ``crisis'' or
senescence, wherein they display abnormal cell morphology and
significant reduction or cessation of cell proliferation. Investigators
at the National Cancer Institute developed immortalized cell line by
isolating bronchial epithelial cells from non-cancerous individuals and
subsequent infection with an adenovirus 12-SV40 virus hybrid. Unlike
normal cells, the immortalized cells be cultured continuously in vitro
in suitable medium and retain features of normal human bronchial
epithelial cells, including the absence of invasive behavior in vitro
or in vivo. These cells can also be transfected with oncogenes and used
as a model for multistage carcinogenesis, or employed to assay a
biological or chemical agent's ability to induce differentiation and
carcinogenesis as well as test potential chemotherapeutic agents.
Applications:
Model to study multistage bronchial carcinogenesis.
Identification of potential chemotherapeutic drugs.
Identification of carcinogenic agents.
Advantages: Immortalized cells that retain normal human bronchial
characteristics.
Market:
Global cancer market is worth more than eight percent of
total global pharmaceutical sales.
Cancer industry is predicted to expand to $85.3 billion by
2010.
Inventors: Curtis C. Harris (NCI) et al.
Relevant Publication: RR Reddel et al. Transformation of human
bronchial epithelial cells by infection with SV40 or adenovirus-12 SV40
hybrid virus, or transfection via stronium phosphate coprecipitation
with a plasmid containing SV40 early region genes. Cancer Res. 1988 Apr
1;48(7):1904-1909. [PubMed: 2450641].
Patent Status: HHS Reference No. E-287-1987/0--Research Material.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Laboratory of Human Carcinogenesis, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize Immortalized Human
Bronchial Epithelial Cell Line. Please contact John Hewes, PhD, at 301-
435-3121 or hewesj@mail.nih.gov for more information.
Dated: July 22, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-18487 Filed 7-27-10; 8:45 am]
BILLING CODE 4140-01-P
