Government-Owned Inventions; Availability for Licensing, 20667-20669 [2013-07917]
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
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SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
The Center for Devices and
Radiological Health (CDRH) believes
that computer modeling and simulation
(M&S) has the potential to substantially
augment traditional models used to
evaluate medical devices; i.e., animal,
bench, and human models, and to
accelerate and streamline the total
product life cycle of a medical device.
The use of computer models to simulate
multiple use conditions and to visualize
and display complex processes and data
can revolutionize the way medical
outcomes and medical devices are
understood. Nonproprietary computer
models could benchmark device
performance, yet lack of access to
biomedical data to construct the models
and rigorous methods to validate the
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models limit their credibility and use.
Before substantial advances in the use of
M&S for regulatory decision making can
be attained, a strategy and consistent
framework to assess the credibility of
M&S is needed. Moreover, to foster good
science for M&S in the medical device
community, CDRH needs to leverage the
expertise in industry and academia to
develop a strategy to scientifically
assess the credibility of M&S and to
develop a resource to publicize
biomedical data, models and their
validation for regulatory use.
II. Topics
Historically, M&S have been used as
development and design optimization
tools, rather than methods by which
performance of final devices can be
demonstrated. Further, modeling
studies that are submitted to the Agency
are supplemental and complement
animal, bench and human testing
provided in:
• Investigational Device Exemptions
(investigational devices),
• 510(k) notifications (class II
devices), and
• Pre-Market Approval applications
(class III devices).
Some of the challenges with the current
uses of M&S are:
• Reports typically lack sufficient
details for adequate assessment because
there are no reporting standards for
computational modeling,
• Lack of sensitivity and uncertainty
analyses for crucial input parameters,
such as geometry, physical properties,
boundary conditions,
• Lack of adequate validation to
support the use of the computational
model, and
• Lack of complete understanding of
physiological loads and variations in
patient populations.
Adequate verification and validation
(V&V) are necessary in order to foster
confidence and wider acceptance of
M&S for use in medical device
evaluation. Therefore, CDRH, in
collaboration with the American Society
of Mechanical Engineers, has been
drafting a guide on the ‘‘Verification and
Validation of Computational Modeling
for Medical Devices.’’ The strategy is
meant to create a framework for
determining the risk associated with
using a computational model in a
specific context of use (COU) to inform
decision making and for determining
‘‘how much’’ V&V is necessary to
support the model for its COU. The two
main components of this strategy are the
Risk Assessment Matrix and the
Credibility Assessment Matrix. Both of
these tools will be presented and
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20667
discussed at the workshop. Note that
these tools are still in DRAFT format.
The workshop will also describe and
discuss FDA’s efforts to create a
resource or Library of biomedical data
and models that can be used in
regulatory applications. Key features
and questions related to development of
the Library and curation of data and
models for the Library will be
discussed. The goal of the FDA/NIH/
NSF Workshop on Computer Modeling
and Validation for Medical Devices is to
discuss and receive input on these tools
to enhance their utility in the
community.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07923 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
FOR FURTHER INFORMATION CONTACT:
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:
Highly Potent and Selective
Deubiquitinating Enzyme Inhibitor
Description of Technology: Available
for licensing are inhibitors that target
the USP1/UAF1 deubiquitnating
enzyme (DUB) complex. The FDA
approval and commercial success of
E:\FR\FM\05APN1.SGM
05APN1
mstockstill on DSK4VPTVN1PROD with NOTICES
20668
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
Velcade®, a small molecule proteasome
inhibitor, has established the ubiquitinproteasome system (UPS) as a valid
target for anticancer treatment.
However, proteasome inhibitors in
general suffer from a narrow therapeutic
index and acquired resistance. A
promising alternative to proteasome
inhibition has been to target the
enzymes upstream of proteasomemediated protein degradation, i.e. the
ubiquitin conjugation and
deconjugation, to generate more
specific, less toxic therapeutic agents.
The investigators have developed small
molecules that target the USP1/UAF1
DUB complex that acts upstream of UPS
and has been implicated in the DNA
damage response. These compounds are
the most potent and selective DUB
inhibitors reported to date. Moreover,
the inhibitors act synergistically with
cisplatin, a DNA damaging anti-cancer
drug, to overcome chemoresistance and
enhance cytotoxicity. These results
suggest the inhibitors may also improve
the efficacy and potency of other
commonly prescribed chemotherapeutic
agents that are known to induce DNA
damage.
Potential Commercial Applications:
• Method to treat cancer
• Method to overcome
chemoresistance to cisplatin
• Pharmaceutical compositions
Competitive Advantages:
• Represents the most potent and
selective DUB inhibitor reported to date.
• Promising alternative to proteasome
inhibition offering the potential of more
selective and less toxic therapeutic
agents.
• Acts synergistically with DNA
damaging agents to overcome
chemoresistance.
Development Stage:
• Early-stage
• In vitro data available
Inventors: David Maloney (NCATS),
Andrew Rosenthal (NCATS), Ajit Jadhav
(NCATS), Thomas Dexheimer (NCATS),
Anton Simeonov (NCATS), Zhihao
Zhuang (University of Delaware), Qin
Liang (University of Delaware), Diane
Luci (NCATS)
Intellectual Property: HHS Reference
No. E–043–2013/0—US Provisional
Application No. 61/747,052 filed 28
December 2012
Related Technologies:
• HHS Reference No. E–208–2007/
0—US Patent Application No. 12/
669,361 filed 15 January 2010
• HHS Reference No. E–156–2012/
0—US Provisional Application No. 61/
692,560 filed 23 August 2012
• HHS Reference No. E–231–2002/
0—US Patent No. 7,498,336 issued 3
March 2009
VerDate Mar<15>2010
17:14 Apr 04, 2013
Jkt 229001
• HHS Reference No. E–070–2005/
0—US Patent No. 8,242,160 issued 14
June 2012 and US Patent Application
No. 13/547,417 filed 12 July 2012
Licensing Contact: Jennifer Wong,
M.S.; 301–435–4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Center for Advancing
Translational Sciences is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize this invention. For
collaboration opportunities, please
contact Lili Portilla at
lili.portilla@nih.gov.
Therapeutic Applications of a CarboxyTerminal RTDL Motif
Description of Technology:
Mesencephalic Astrocyte-derived
Neurotrophic Factor (MANF) is a
secreted neurotrophic factor with
known anti-neurodegenerative
properties. The inventors discovered
that the C-terminal RTDL motif of
MANF is involved in the antidegenerative properties of MANF and
association of extracellular MANF with
the cell surface. Isolated peptides,
including the C-terminal RTDL motif of
MANF, potentially can be used as a
treatment for neurodegenerative
disorders and ischemia.
Potential Commercial Applications:
Treating neurodegenerative diseases,
such as Alzheimer’s disease,
Parkinson’s disease, Huntington disease,
etc.
Competitive Advantages: Secreted
novel peptides.
Development Stage:
• Early-stage
• Pre-clinical
• In vitro data available
Inventors: Brandon K Harvey, et al.
(NIDA)
Intellectual Property: HHS Reference
No. E–249–2012/0—US Provisional
Application 61/732, 241 filed 30 Nov
2012
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov
HIV-Neutralizing Polypeptides: A Novel
Use for Platelet Factor 4 or Its
Derivatives
Description of Technology: The
subject invention describes the method
for using Platelet Factor 4 (PF4), also
called CXCL4, to inhibit HIV viral entry
by blocking GP120 independent of HIV
receptor. It also demonstrates that the
active polypeptide fragment(s) of PF–4
could be used to identify potential
peptide mimics or small molecules that
could be used to inhibit HIV infection.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
PF4 and/or its derivatives may be
developed as a systemic therapy or
preventive measure using topical
applications, such as microbicides. In
addition, CXCL4 serum/plasma testing
could be used as a clinical marker of
HIV disease status to predict/monitor
the efficacy of treatment and determine
the prognosis of a subject with HIV
infection.
Potential Commercial Applications:
• Treatment and prevention of HIV–
1 infection.
• Topical application as
microbicides.
• A vaccine adjuvant to boost the
vaccine efficacy.
• A clinical marker of HIV disease
status or to predict/monitor the efficacy
of treatment or vaccines.
Competitive Advantages:
• A new HIV–1 inhibitory molecule
that acts through a new inhibitory
mechanism.
• Any potential derivative or
mimicking compound would be unique
and have the advantage of hitting a
previously unrecognized molecular
target in the HIV life cycle.
Development Stage:
• Early-stage
• In vitro data available
Inventors: Paolo Lusso and David J.
Auerbach (NIAID)
Publication: Auerbach DJ, et al.
Identification of the platelet-derived
chemokine CXCL4/PF–4 as a broadspectrum HIV–1 inhibitor. Proc Natl
Acad Sci USA 2012 Jun
12;109(24):9569–74. [PMID 22645343]
Intellectual Property: HHS Reference
No. E–140–2012/0—US Application No.
61/649,150 filed 19 Jun 2012
Related Technology: The CXCL4
sequence is in the public domain.
Licensing Contact: Sally Hu, Ph.D.,
MBA; 301–435–5606; hus@mail.nih.gov.
Polarimetric Accessory for Colposcope
Description of Technology: Available
for licensing and commercial
development is a colposcope accessory
device that compensates and resolves
tissue borne specular reflections. In
medical diagnostic procedures for
examining the cervix and the tissues of
the vagina and vulva, long workingdistance (¥30 cm) lighted binocular
microscope (colposcope) that provide
up to 25x optical magnification are used
to create an illuminated magnified view.
Speculum dilations can give rise to
specular reflections from the tissue
surface. The present polarimetric
accessory overcomes this limitation and
enhances the visibility of subsurface
structures of the scattering object.
Linearly polarized light is used for
cervical illumination and imaging is
E:\FR\FM\05APN1.SGM
05APN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
performed through an additional
polarizer that separates the specularly
reflected light from the diffusely
backscattered light, which originates in
deeper tissue layers, allowing enhanced
imaging of the hidden subsurface tissue
structure (texture). The region of interest
is illuminated by linearly polarized
light, and backscattered light passes
through the polarization filter to be
detected by a digital camera. A custom
optical design preserves the polarization
state of the backscattered light in the
microscope, without interfering with the
standard optical path and operation of
the microscope, including its binocular
system. Special algorithms to visualize
regions of statistical similarity in the
image have been developed. Though the
diffusely backscattered light presents
only a small fraction of the detected
light, its analysis, using the customized
design and image processing
procedures, provides useful information
about internal structures of biological
tissues. The polarimetric accessory
includes a linear polarizer for the
illuminating beam, two beam splitters
for preserving polarization state, lens
system for imaging, polarization
analyzer, band-pass optical filter, digital
camera, and electronic triggering
system.
Potential Commercial Applications:
Gynecological examinations
Competitive Advantages:
• Image quality
• Resolution of tissue structures at
close microscopic distances
Development Stage: Prototype
Inventors: Amir Gandjbakhche
(NICHD), Victor Chernomordik
(NICHD), Moinuddin Hassan (NICHD),
Alexander Sviridov (NICHD), Zachary
Alissi (NICHD), Paul Smith (NIBIB),
Albert Boccara (NICHD)
Publications:
1. Jacques SL, et al. Imaging
superficial tissues with polarized light.
Lasers Surg Med. 2000;26(2):119–29.
[PMID 10685085]
2. Jacques SL, et al. Imaging skin
pathology with polarized light. J Biomed
Opt. 2002 Jul;7(3):329–40. [PMID
12175282]
3. Ramella-Roman JC, et al. Design,
testing, and clinical studies of a
handheld polarized light camera. J
Biomed Opt. 2004 Nov–Dec;9(6):1305–
10. [PMID 15568952]
4. Sviridov AP, et al. ‘‘Analysis of
Biological Tissue Textures Using
Measurements of Backscattered
Polarized Light’’ (presented at the
Optical Society of America—Biomedical
Optics Topical Meeting, Fort
Lauderdale, Florida, March 2006).
5. Sviridov AP, et al. Visualization of
biological texture using correlation
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Jkt 229001
coefficient images. J Biomed Opt. 2006
Nov–Dec;11(6):060504. [PMID
17212522]
Intellectual Property: HHS Reference
No. E–084–2012—US Provisional Patent
Application No. 61/620,295 filed 04 Apr
2012
Licensing Contact: Michael A.
Shmilovich, Esq., CLP; 301–435–5019;
shmilovm@mail.nih.gov
CpG Oligonucleotides Treatment To
Prevent Chemotherapy-Induced
Pulmonary Toxicity
Description of Technology: Bleomycin
(BLM) is a chemotherapy agent used to
treat multiple types of cancer, but its
side effects are life threatening for some
patients. About 20% of patients
undergoing BLM chemotherapy develop
interstitial pneumonitis which may
develop to life threatening fibrosis. In
such cases, BLM chemotherapy cannot
be continued.
This invention identifies a method of
pre-treatment using immunostimulatory
CpG Oligonucleotide (ODN) molecules
to prevent chemotherapy-induced
pulmonary toxicity. Administration of
certain ODN molecules induces
inflammation via stimulation of
inflammatory genes (Toll-like receptor
9/TLR9). This stimulation is
subsequently down-regulated. This
technology makes use of this counter
regulatory mechanism to reduce the side
effects of chemotherapy agents, such as
BML. A properly timed preadministration of ODN molecules, prior
to BML therapy, prevents the lethal side
effect of BLM-induced pulmonary
inflammation and down-regulates
promoters of BLM toxicity (IL–17A and
TGF-beta1). Because toxicity from
pulmonary inflammation is a side effect
limiting use of many chemotherapeutic
agents and ODN molecules are relatively
inexpensive and have a favorable safety
profile, this technology may be useful to
improve treatment protocols for many
chemotherapy agents.
Potential Commercial Applications:
Therapeutic to reduce harmful side
effects of pulmonary inflammation
caused by chemotherapy.
Competitive Advantages:
• Pulmonary toxicity during
chemotherapy is dangerous side effect,
this technology uses ODN molecules
that are relatively inexpensive and have
a favorable safety profile to reduce this
side effect.
• This technology may increase the
safety and availability of many
chemotherapy treatments.
Development Stage:
• Early-stage
• In vivo data available (animal)
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20669
Inventors: Dennis Klinman and
Takeshi Kinjo (NCI)
Publication: Kinjo T, et al. The
counter regulatory response induced by
CpG oligonucleotides prevents
bleomycin induced pneumopathy.
Respir Res. 2012 Jun 18;13:47. [PMID
22708497]
Intellectual Property: HHS Reference
No. E–077–2012/0—U.S. Provisional
Patent Application No. 61/643,088 filed
04 May 2012
Licensing Contact: Edward (Tedd)
Fenn; 301–435–5031;
fenned@mail.nih.gov
Collaborative Research Opportunity:
The National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize CpG oligonucleotides for
use to down-modulate inflammatory
reactions. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at hewesj@mail.nih.gov.
Dated: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–07917 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Management
of the Primate Aging Database
Date: April 23, 2013.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892,
(Telephone Conference Call).
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20667-20669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07917]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, 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.
FOR FURTHER INFORMATION CONTACT: 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.
Highly Potent and Selective Deubiquitinating Enzyme Inhibitor
Description of Technology: Available for licensing are inhibitors
that target the USP1/UAF1 deubiquitnating enzyme (DUB) complex. The FDA
approval and commercial success of
[[Page 20668]]
Velcade[supreg], a small molecule proteasome inhibitor, has established
the ubiquitin-proteasome system (UPS) as a valid target for anticancer
treatment. However, proteasome inhibitors in general suffer from a
narrow therapeutic index and acquired resistance. A promising
alternative to proteasome inhibition has been to target the enzymes
upstream of proteasome-mediated protein degradation, i.e. the ubiquitin
conjugation and deconjugation, to generate more specific, less toxic
therapeutic agents. The investigators have developed small molecules
that target the USP1/UAF1 DUB complex that acts upstream of UPS and has
been implicated in the DNA damage response. These compounds are the
most potent and selective DUB inhibitors reported to date. Moreover,
the inhibitors act synergistically with cisplatin, a DNA damaging anti-
cancer drug, to overcome chemoresistance and enhance cytotoxicity.
These results suggest the inhibitors may also improve the efficacy and
potency of other commonly prescribed chemotherapeutic agents that are
known to induce DNA damage.
Potential Commercial Applications:
Method to treat cancer
Method to overcome chemoresistance to cisplatin
Pharmaceutical compositions
Competitive Advantages:
Represents the most potent and selective DUB inhibitor
reported to date.
Promising alternative to proteasome inhibition offering
the potential of more selective and less toxic therapeutic agents.
Acts synergistically with DNA damaging agents to overcome
chemoresistance.
Development Stage:
Early-stage
In vitro data available
Inventors: David Maloney (NCATS), Andrew Rosenthal (NCATS), Ajit
Jadhav (NCATS), Thomas Dexheimer (NCATS), Anton Simeonov (NCATS),
Zhihao Zhuang (University of Delaware), Qin Liang (University of
Delaware), Diane Luci (NCATS)
Intellectual Property: HHS Reference No. E-043-2013/0--US
Provisional Application No. 61/747,052 filed 28 December 2012
Related Technologies:
HHS Reference No. E-208-2007/0--US Patent Application No.
12/669,361 filed 15 January 2010
HHS Reference No. E-156-2012/0--US Provisional Application
No. 61/692,560 filed 23 August 2012
HHS Reference No. E-231-2002/0--US Patent No. 7,498,336
issued 3 March 2009
HHS Reference No. E-070-2005/0--US Patent No. 8,242,160
issued 14 June 2012 and US Patent Application No. 13/547,417 filed 12
July 2012
Licensing Contact: Jennifer Wong, M.S.; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Center for
Advancing Translational Sciences is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize this invention. For collaboration
opportunities, please contact Lili Portilla at lili.portilla@nih.gov.
Therapeutic Applications of a Carboxy-Terminal RTDL Motif
Description of Technology: Mesencephalic Astrocyte-derived
Neurotrophic Factor (MANF) is a secreted neurotrophic factor with known
anti-neurodegenerative properties. The inventors discovered that the C-
terminal RTDL motif of MANF is involved in the anti-degenerative
properties of MANF and association of extracellular MANF with the cell
surface. Isolated peptides, including the C-terminal RTDL motif of
MANF, potentially can be used as a treatment for neurodegenerative
disorders and ischemia.
Potential Commercial Applications: Treating neurodegenerative
diseases, such as Alzheimer's disease, Parkinson's disease, Huntington
disease, etc.
Competitive Advantages: Secreted novel peptides.
Development Stage:
Early-stage
Pre-clinical
In vitro data available
Inventors: Brandon K Harvey, et al. (NIDA)
Intellectual Property: HHS Reference No. E-249-2012/0--US
Provisional Application 61/732, 241 filed 30 Nov 2012
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov
HIV-Neutralizing Polypeptides: A Novel Use for Platelet Factor 4 or Its
Derivatives
Description of Technology: The subject invention describes the
method for using Platelet Factor 4 (PF4), also called CXCL4, to inhibit
HIV viral entry by blocking GP120 independent of HIV receptor. It also
demonstrates that the active polypeptide fragment(s) of PF-4 could be
used to identify potential peptide mimics or small molecules that could
be used to inhibit HIV infection. PF4 and/or its derivatives may be
developed as a systemic therapy or preventive measure using topical
applications, such as microbicides. In addition, CXCL4 serum/plasma
testing could be used as a clinical marker of HIV disease status to
predict/monitor the efficacy of treatment and determine the prognosis
of a subject with HIV infection.
Potential Commercial Applications:
Treatment and prevention of HIV-1 infection.
Topical application as microbicides.
A vaccine adjuvant to boost the vaccine efficacy.
A clinical marker of HIV disease status or to predict/
monitor the efficacy of treatment or vaccines.
Competitive Advantages:
A new HIV-1 inhibitory molecule that acts through a new
inhibitory mechanism.
Any potential derivative or mimicking compound would be
unique and have the advantage of hitting a previously unrecognized
molecular target in the HIV life cycle.
Development Stage:
Early-stage
In vitro data available
Inventors: Paolo Lusso and David J. Auerbach (NIAID)
Publication: Auerbach DJ, et al. Identification of the platelet-
derived chemokine CXCL4/PF-4 as a broad-spectrum HIV-1 inhibitor. Proc
Natl Acad Sci USA 2012 Jun 12;109(24):9569-74. [PMID 22645343]
Intellectual Property: HHS Reference No. E-140-2012/0--US
Application No. 61/649,150 filed 19 Jun 2012
Related Technology: The CXCL4 sequence is in the public domain.
Licensing Contact: Sally Hu, Ph.D., MBA; 301-435-5606;
hus@mail.nih.gov.
Polarimetric Accessory for Colposcope
Description of Technology: Available for licensing and commercial
development is a colposcope accessory device that compensates and
resolves tissue borne specular reflections. In medical diagnostic
procedures for examining the cervix and the tissues of the vagina and
vulva, long working-distance (-30 cm) lighted binocular microscope
(colposcope) that provide up to 25x optical magnification are used to
create an illuminated magnified view. Speculum dilations can give rise
to specular reflections from the tissue surface. The present
polarimetric accessory overcomes this limitation and enhances the
visibility of subsurface structures of the scattering object. Linearly
polarized light is used for cervical illumination and imaging is
[[Page 20669]]
performed through an additional polarizer that separates the specularly
reflected light from the diffusely backscattered light, which
originates in deeper tissue layers, allowing enhanced imaging of the
hidden subsurface tissue structure (texture). The region of interest is
illuminated by linearly polarized light, and backscattered light passes
through the polarization filter to be detected by a digital camera. A
custom optical design preserves the polarization state of the
backscattered light in the microscope, without interfering with the
standard optical path and operation of the microscope, including its
binocular system. Special algorithms to visualize regions of
statistical similarity in the image have been developed. Though the
diffusely backscattered light presents only a small fraction of the
detected light, its analysis, using the customized design and image
processing procedures, provides useful information about internal
structures of biological tissues. The polarimetric accessory includes a
linear polarizer for the illuminating beam, two beam splitters for
preserving polarization state, lens system for imaging, polarization
analyzer, band-pass optical filter, digital camera, and electronic
triggering system.
Potential Commercial Applications: Gynecological examinations
Competitive Advantages:
Image quality
Resolution of tissue structures at close microscopic
distances
Development Stage: Prototype
Inventors: Amir Gandjbakhche (NICHD), Victor Chernomordik (NICHD),
Moinuddin Hassan (NICHD), Alexander Sviridov (NICHD), Zachary Alissi
(NICHD), Paul Smith (NIBIB), Albert Boccara (NICHD)
Publications:
1. Jacques SL, et al. Imaging superficial tissues with polarized
light. Lasers Surg Med. 2000;26(2):119-29. [PMID 10685085]
2. Jacques SL, et al. Imaging skin pathology with polarized light.
J Biomed Opt. 2002 Jul;7(3):329-40. [PMID 12175282]
3. Ramella-Roman JC, et al. Design, testing, and clinical studies
of a handheld polarized light camera. J Biomed Opt. 2004 Nov-
Dec;9(6):1305-10. [PMID 15568952]
4. Sviridov AP, et al. ``Analysis of Biological Tissue Textures
Using Measurements of Backscattered Polarized Light'' (presented at the
Optical Society of America--Biomedical Optics Topical Meeting, Fort
Lauderdale, Florida, March 2006).
5. Sviridov AP, et al. Visualization of biological texture using
correlation coefficient images. J Biomed Opt. 2006 Nov-
Dec;11(6):060504. [PMID 17212522]
Intellectual Property: HHS Reference No. E-084-2012--US Provisional
Patent Application No. 61/620,295 filed 04 Apr 2012
Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019;
shmilovm@mail.nih.gov
CpG Oligonucleotides Treatment To Prevent Chemotherapy-Induced
Pulmonary Toxicity
Description of Technology: Bleomycin (BLM) is a chemotherapy agent
used to treat multiple types of cancer, but its side effects are life
threatening for some patients. About 20% of patients undergoing BLM
chemotherapy develop interstitial pneumonitis which may develop to life
threatening fibrosis. In such cases, BLM chemotherapy cannot be
continued.
This invention identifies a method of pre-treatment using
immunostimulatory CpG Oligonucleotide (ODN) molecules to prevent
chemotherapy-induced pulmonary toxicity. Administration of certain ODN
molecules induces inflammation via stimulation of inflammatory genes
(Toll-like receptor 9/TLR9). This stimulation is subsequently down-
regulated. This technology makes use of this counter regulatory
mechanism to reduce the side effects of chemotherapy agents, such as
BML. A properly timed pre-administration of ODN molecules, prior to BML
therapy, prevents the lethal side effect of BLM-induced pulmonary
inflammation and down-regulates promoters of BLM toxicity (IL-17A and
TGF-beta1). Because toxicity from pulmonary inflammation is a side
effect limiting use of many chemotherapeutic agents and ODN molecules
are relatively inexpensive and have a favorable safety profile, this
technology may be useful to improve treatment protocols for many
chemotherapy agents.
Potential Commercial Applications: Therapeutic to reduce harmful
side effects of pulmonary inflammation caused by chemotherapy.
Competitive Advantages:
Pulmonary toxicity during chemotherapy is dangerous side
effect, this technology uses ODN molecules that are relatively
inexpensive and have a favorable safety profile to reduce this side
effect.
This technology may increase the safety and availability
of many chemotherapy treatments.
Development Stage:
Early-stage
In vivo data available (animal)
Inventors: Dennis Klinman and Takeshi Kinjo (NCI)
Publication: Kinjo T, et al. The counter regulatory response
induced by CpG oligonucleotides prevents bleomycin induced pneumopathy.
Respir Res. 2012 Jun 18;13:47. [PMID 22708497]
Intellectual Property: HHS Reference No. E-077-2012/0--U.S.
Provisional Patent Application No. 61/643,088 filed 04 May 2012
Licensing Contact: Edward (Tedd) Fenn; 301-435-5031;
fenned@mail.nih.gov
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
CpG oligonucleotides for use to down-modulate inflammatory reactions.
For collaboration opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Dated: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-07917 Filed 4-4-13; 8:45 am]
BILLING CODE 4140-01-P
