Government-Owned Inventions; Availability for Licensing, 24756-24758 [2013-09902]
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24756
Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
The annual estimate of burden is as
follows:
Number of
respondents
Form name
Responses
per
respondent
Total
responses
Hours per
response
Total
burden
hours
Medicare Rural Hospital Flexibility Grant Program .............
45
1
45
216
9,720
Total ..............................................................................
45
1
45
216
9,720
Submit your comments to
the desk officer for HRSA, either by
email to OIRA_submission@
omb.eop.gov or by fax to 202–395–5806.
Please direct all correspondence to the
‘‘attention of the desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
ADDRESSES:
Dated: April 22, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–09946 Filed 4–25–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Replacement Award to Genesee Health
System.
AGENCY:
The Health Resources and
Services Administration (HRSA) will be
transferring Health Center Program
(section 330 of the Public Health Service
Act) funds originally awarded to the
County of Genesee to ensure the
provision of critical primary health care
services to underserved populations in
Genesee County, Michigan.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: County of
Genesee.
Original Period of Grant Support:
June 1, 2012, to April 30, 2014.
Replacement Awardee: Genesee
Health System.
Amount of Replacement Award: The
original award to the County of Genesee
was issued as a result of a New Access
Point application. The County of
Genesee and Genesee Health System
have agreed that the funds to be
transferred will be the remaining
amount in the account as of the date of
this transfer.
erowe on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:46 Apr 25, 2013
Jkt 229001
Period of Replacement Award: The
period of support for the replacement
award is May 1, 2013, to April 30, 2014.
Dated: April 19, 2013.
Mary K. Wakefield,
Administrator.
Authority: Sections 330 of the Public
Health Service Act, 42 U.S.C. 245b.
CFDA Number: 93.224.
[FR Doc. 2013–09942 Filed 4–25–13; 8:45 am]
Justification for the Exception to
Competition: The former grantee, the
County of Genesee, has requested that
HRSA transfer a Health Center Program
section 330 grant to Genesee Health
System to implement and carry out
grant activities originally proposed
under the County of Genesee’s funded
section 330 grant application. Genesee
County Community Mental Health
(GCCMH)—now Genesee Health
System—was formerly a department of
the County of Genesee and has
continued to carry out the operations of
the grant program since its award in
June 2012. On January 1, 2013, the State
of Michigan approved GCCMH’s
independence as a separate public
governmental entity, and GCCMH was
legally renamed the Genesee Health
System. The Genesee Health System is
directly engaged in the delivery of
primary health care services on the
County of Genesee’s behalf and has
indicated an ability to continue
operations without a disruption of
services.
Genesee Health System is currently
providing primary health care services
on behalf of the County of Genesee to
the original target population and is
located in the same geographical area.
This underserved target population has
an immediate need for vital primary
health care services and would be
negatively impacted by any delay or
disruption of services caused by a
competition. As a result, in order to
ensure that critical primary health care
services remain available to the original
target population without disruption,
this replacement award will not be
competed.
FOR FURTHER INFORMATION CONTACT:
Kirsten Argueta, Senior Advisor, North
Central Division, Bureau of Primary
Health Care, Health Resources and
Services Administration, 5600 Fishers
Lane, Rockville, MD 20857, via email at
KArgueta@hrsa.gov or (301) 594–1055.
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BILLING CODE 4165–15–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.
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:
Zirconium-89 PET Imaging Agent for
Cancer
Description of Technology: This
technology is a new generation of
rationally designed chelating agents
which improve the complexation of
Zirconium-89 for PET imaging of
cancers. The technology uses cyclic or
acyclic chelators made of 4
hydroxamate donors groups for
improved stability compared to the
currently used natural product
siderophore desferrioxamine B (DFB), a
E:\FR\FM\26APN1.SGM
26APN1
erowe on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
chelator that consists of only 3
hydroxamate donors that fails to
saturate the coordination sphere of
Zr(IV). DFB, which has been the object
of many pre-clinical and clinical studies
exhibits insufficient stability resulting
in progressive radioisotope
accumulation in bone once injected that
can contribute to toxicity and increased
background. The new chelators
described in this invention have shown
improved kinetic inertness compared to
DFB with stability up to 90% after 7
days compared to 28% for DFB. In
association with an adequate targeting
agent such as an antibody, toxicity to
the bone can be reduced and images
with better contrast can be obtained
with these new chelators.
Potential Commercial Applications:
• Cancer imaging.
• PET imaging.
• ImmunoPET.
Competitive Advantages:
• High stability.
• Low toxicity.
• Better imaging contrast.
Development Status:
• Prototype.
• In vitro data available.
Inventors: Francois Guerard (NCI),
Yong Sok Lee (CIT), Martin Brechbiel
(NCI).
Publications:
1. Zhou Y, et al. Mapping biological
behaviors by application of longer-lived
positron emitting radionuclides. Adv
Drug Deliv Rev. In Press; doi: 10.1016/
j.addr.2012.10.012. [PMID 23123291].
2. Deri MA, et al. PET imaging with
89Zr: from radiochemistry to the clinic.
Nucl Med Biol. 2013 Jan;40(1):3–14.
[PMID 22998840].
3. Vosjan MJ, et al. Conjugation and
radiolabeling of monoclonal antibodies
with zirconium-89 for PET imaging
using the bifunctional chelate pisothiocyanatobenzyl-desferrioxamine.
Nat Protoc. 2010 Apr;5(4):739–43.
[PMID 20360768].
4. Nayak TK, et al. PET and MRI of
metastatic peritoneal and pulmonary
colorectal cancer in mice with human
epidermal growth factor receptor 1targeted 89Zr-labeled panitumumab. J
Nucl Med. 2012 Jan;53(1):113–20.
[PMID 22213822].
5. Evans MJ, et al. Imaging tumor
burden in the brain with 89Zrtransferrin. J Nucl Med. 2013
Jan;54(1):90–5. [PMID 23236019].
6. Guerard F, et al. Investigation of
Zr(IV) and 89Zr(IV) complexation with
hydroxamates: progress towards
designing a better chelator than
desferrioxamine B for immuno-PET
imaging. Chem Commun (Camb). 2013
Feb 1;49(10):1002–4. [PMID 23250287].
Intellectual Property: HHS Reference
No. E–111–2013/0—U.S. Provisional
VerDate Mar<15>2010
14:46 Apr 25, 2013
Jkt 229001
Application No. 61/779,016 filed 13 Mar
2013.
Related Technologies:
• HHS Reference No. E–194–2007/
0—U.S. Patent Application No. 12/
667,790 filed 05 Jan 2010.
• HHS Reference No. E–226–2006/
0—U.S. Patent No. 8,288,530 issued 16
Oct 2012.
• HHS Reference No. E–067–1990/0.
Licensing Contact: Michael A.
Shmilovich; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The Radioimmune & Inorganic
Chemistry Section, ROB, CCR, NCI, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
Zirconium-89 chelation technology for
ImmunoPET imaging and other
applications. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at hewesj@mail.nih.gov.
Novel Methods for Generating Retinal
Pigment Epithelium Cells From Induced
Pluripotent Stem Cells
Description of Technology: High
efficiency methods for producing retinal
pigment epithelial cells (RPE) from
induced pluripotent stem cells (iPSCs)
are disclosed. The RPE is a polarized
monolayer in the vertebrate eye that
separates the neural retina from the
choroid, and performs a crucial role in
retinal physiology by forming a bloodretinal barrier and closely interacting
with photoreceptors to maintain visual
function. Many ophthalmic diseases,
such as age-related macular
degeneration, are associated with a
degeneration or deterioration of the
RPE. The iPSCs are produced from
somatic cells, including retinal pigment
epithelial cells, such as fetal RPE. These
methods involve producing embryoid
bodies from human iPSCs, culturing the
embryoid bodies using specific media to
induce differentiation into RPE and
growing the differentiated RPE cells in
a defined media to generate human RPE
cells. The investigators also developed
methods for detecting RPE cells and
authenticating RPE cells; determining
agents that can affect the production of
RPE cells from an iPSC; and identifying
an agent that can increase RPE survival
in response to a proteo toxic insult or
stress. The novel methods and RPE cells
disclosed here can be useful for both
pre-clinical and clinical studies
involving RPE.
Potential Commercial Applications:
The methods described here can be used
to:
• Produce RPE cells for use in
screening for novel ocular therapeutics
PO 00000
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24757
and for identifying toxic side effects of
drugs.
• Produce RPE cells for use in novel
cell-based therapies.
• Produce cells to study
pathophysiology of RPE.
Competitive Advantages: The
methods described here:
• Dramatically increase the efficiency
of iPSC differentiation into RPE.
• Produce superior quality RPE.
• Produce RPE cells that are fully
authenticated.
• Provide ways to perform high
throughput screens with RPE cells.
Development Stage:
• Prototype.
• Early-stage.
• In vitro data available.
Intellectual Property: HHS Reference
No. E–251–2012/3—U.S. Provisional
Application No. 61/759,988 filed 01 Feb
2013.
Licensing Contact: Suryanarayana
(Sury) Vepa; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Eye Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize iPSC to RPE
differentiation protocol, its clinical,
screening, and translational
applications. For collaboration
opportunities, please contact Alan
Hubbs, Ph.D. at hubbsa@mail.nih.gov.
Novel Tocopherol and Tocopheryl
Quinone Derivatives as Therapeutics
for Lysosomal Storage Disorders
Description of Technology: Novel
tocopherol derivatives and tocopheryl
quinone derivatives useful in the
decrease of lysosomal substrate
accumulation, the restoration of normal
lysosomal size, and the treatment of
lysosomal storage disorders (LSDs) are
provided. The inventors have
discovered that tocopherol and
tocopheryl quinone derivatives with
side chain modifications (such as
terminal tri-halogenated methyl groups)
exhibit improved pharmacokinetics,
modulation of mitochondrial potential
and restoration of some LSDs
phenotypes. These molecules by
themselves or in combination with
Cyclodextrins (CDs) increase
intracellular Ca2+ and enhance
exocytosis. Also, the treatment with
these compounds reduced the
pathological changes in the
ultrastructure of LSD cells as observed
using electron microscopy analysis. The
inventors also found that there is a
synergy between CDs and the new
tocopherol analogues when tested on
the NPC cells and cells from six other
E:\FR\FM\26APN1.SGM
26APN1
24758
Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
erowe on DSK2VPTVN1PROD with NOTICES
lysosomal storage diseases including
Wolman, Niemann Pick Type A, Farber,
TaySachs, MSIIIB and CLN2 (Batten)
diseases. These new tocopherol
analogues are as good or better than
natural occurring tocopherols and
tocotrienols in reducing cholesterol
accumulation in several LSDs.
Potential Commercial Applications:
To develop new therapeutics to treat
LSDs.
Competitive Advantages:
• The main advantage of the
compounds disclosed here is their
improved pharmacokinetics.
• The combination of CD and the
novel tocopherol analogues may reduce
the dosage of each drug and thereby
reduce the potential side effects.
Development Stage:
• Prototype.
• Early-stage.
• Pre-clinical.
• In vitro data available.
Inventors: Juan Jose Marugan, Wei
Zheng, Jingbo Xiao, and John McKew
(NCATS).
Intellectual Property: HHS Reference
No. E–148–2012/0—U.S. Provisional
Application No. 61/727,296 filed 16
Nov 2012.
Related Technologies:
• HHS Reference No. E–294–2009/
0—PCT Application No. PCT/US2011/
044590 filed 19 Jul 2011, which
published as WO 2012/012473 on 26 Jan
2012.
• HHS Reference No. E–050–2012/
0—US Provisional Application No. 61/
679,668 filed 12 Aug 2012.
Licensing Contact: Suryanarayana
(Sury) Vepa; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunities:
The National Center for Advancing
Translational Sciences (NCATS) is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
Novel Tocopherol and Tocopheryl
Quinone Derivatives as Therapeutics for
Lysosomal Storage Disorders. For
collaboration opportunities, please
contact the NCATS Technology
Development Coordinator at
NCATSPartnerships@mail.nih.gov.
Dated: April 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–09902 Filed 4–25–13; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
14:46 Apr 25, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
April 23, 2013.
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:
Device for Non-Surgical Tricuspid
Valve Annuloplasty
Description of Technology: This is a
non-surgical tricuspid annuloplasty to
treat functional tricuspid valve
regurgitation, meaning regurgitation
with intact valve leaflets. The device is
delivered using novel catheter
techniques into the pericardial space
and positioned along the
atrioventricular groove. A compression
member is positioned along the
tricuspid annular free wall and tension
applied through a variably-applied
tension element. In the best
embodiment, the compression member
has an M shaped portion with at least
two inflection points between the
segments of difference curvatures.
Potential Commercial Applications:
• Valvular heart disease.
• Tricuspid valve annuloplasty.
Competitive Advantages:
• Non-surgical catheter treatment of
valve disease.
• Tricuspid valve.
Development Stage:
• Prototype.
• Pre-clinical.
• In vitro data available.
PO 00000
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Fmt 4703
Sfmt 4703
• In vivo data available (animal).
Inventors: Robert Lederman, Kanishka
Ratnayaka, Toby Rogers (NHLBI).
Intellectual Property: HHS Reference
No. E–027–2013—US Provisional Patent
Application 61/785,652 filed 14 Mar
2013.
Related Technologies: HHS Reference
Nos. E–112–2010; E–108–2010; E–165–
2008; E–249–2006/0,/1,/2.
Licensing Contact: Michael A.
Shmilovich, Esq., CLP; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NHLBI is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize technologies for
functional tricuspid valve regurgitation.
For collaboration opportunities, please
contact Peg Koelble at
koelblep@nhlbi.nih.gov.
Urine-Based Diagnostic Assay for the
Early Detection of Cancer
Description of Technology: NIH
scientists have identified a panel of
metabolite biomarkers capable of
predicting the onset of cancer with an
accuracy approaching 100%. Concerted
changes in the levels of select amino
acid, nucleic acid and methylation
metabolites in the urine of mice strongly
correlated with tumor formation and
reflected the progressive derangement in
their underlying biochemical pathways.
Researchers have developed highthroughput screening methodology to
quantify the levels of these metabolites
in biological samples for the purposes of
assessing cancer risk, determining
disease prognosis and monitoring
response to therapy. While applicable to
many cancers, use of this technology for
the detection of colorectal cancer
represents a first-in-class diagnostic for
this particular disease.
Despite therapeutic advances,
colorectal cancer remains a significant
clinical burden in terms of morbidity
and mortality. Early detection is a key
predictor of treatment outcome;
however, current diagnostic methods
are unsuitable for widespread
implementation. The ability to analyze
noninvasively obtained patient samples
in a high-throughput manner suggests
that this technology is well positioned
to serve as a population-level screening
tool for the early detection of many
cancers, including, colorectal.
Potential Commercial Applications:
• A diagnostic screen for the
detection of colorectal and other
cancers.
• Assay to monitor response to
therapy and disease recurrence.
Competitive Advantages:
E:\FR\FM\26APN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24756-24758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09902]
-----------------------------------------------------------------------
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.
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.
Zirconium-89 PET Imaging Agent for Cancer
Description of Technology: This technology is a new generation of
rationally designed chelating agents which improve the complexation of
Zirconium-89 for PET imaging of cancers. The technology uses cyclic or
acyclic chelators made of 4 hydroxamate donors groups for improved
stability compared to the currently used natural product siderophore
desferrioxamine B (DFB), a
[[Page 24757]]
chelator that consists of only 3 hydroxamate donors that fails to
saturate the coordination sphere of Zr(IV). DFB, which has been the
object of many pre-clinical and clinical studies exhibits insufficient
stability resulting in progressive radioisotope accumulation in bone
once injected that can contribute to toxicity and increased background.
The new chelators described in this invention have shown improved
kinetic inertness compared to DFB with stability up to 90% after 7 days
compared to 28% for DFB. In association with an adequate targeting
agent such as an antibody, toxicity to the bone can be reduced and
images with better contrast can be obtained with these new chelators.
Potential Commercial Applications:
Cancer imaging.
PET imaging.
ImmunoPET.
Competitive Advantages:
High stability.
Low toxicity.
Better imaging contrast.
Development Status:
Prototype.
In vitro data available.
Inventors: Francois Guerard (NCI), Yong Sok Lee (CIT), Martin
Brechbiel (NCI).
Publications:
1. Zhou Y, et al. Mapping biological behaviors by application of
longer-lived positron emitting radionuclides. Adv Drug Deliv Rev. In
Press; doi: 10.1016/j.addr.2012.10.012. [PMID 23123291].
2. Deri MA, et al. PET imaging with 89Zr: from radiochemistry to
the clinic. Nucl Med Biol. 2013 Jan;40(1):3-14. [PMID 22998840].
3. Vosjan MJ, et al. Conjugation and radiolabeling of monoclonal
antibodies with zirconium-89 for PET imaging using the bifunctional
chelate p-isothiocyanatobenzyl-desferrioxamine. Nat Protoc. 2010
Apr;5(4):739-43. [PMID 20360768].
4. Nayak TK, et al. PET and MRI of metastatic peritoneal and
pulmonary colorectal cancer in mice with human epidermal growth factor
receptor 1-targeted 89Zr-labeled panitumumab. J Nucl Med. 2012
Jan;53(1):113-20. [PMID 22213822].
5. Evans MJ, et al. Imaging tumor burden in the brain with 89Zr-
transferrin. J Nucl Med. 2013 Jan;54(1):90-5. [PMID 23236019].
6. Guerard F, et al. Investigation of Zr(IV) and 89Zr(IV)
complexation with hydroxamates: progress towards designing a better
chelator than desferrioxamine B for immuno-PET imaging. Chem Commun
(Camb). 2013 Feb 1;49(10):1002-4. [PMID 23250287].
Intellectual Property: HHS Reference No. E-111-2013/0--U.S.
Provisional Application No. 61/779,016 filed 13 Mar 2013.
Related Technologies:
HHS Reference No. E-194-2007/0--U.S. Patent Application
No. 12/667,790 filed 05 Jan 2010.
HHS Reference No. E-226-2006/0--U.S. Patent No. 8,288,530
issued 16 Oct 2012.
HHS Reference No. E-067-1990/0.
Licensing Contact: Michael A. Shmilovich; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The Radioimmune & Inorganic
Chemistry Section, ROB, CCR, NCI, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate or commercialize Zirconium-89 chelation
technology for ImmunoPET imaging and other applications. For
collaboration opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Novel Methods for Generating Retinal Pigment Epithelium Cells From
Induced Pluripotent Stem Cells
Description of Technology: High efficiency methods for producing
retinal pigment epithelial cells (RPE) from induced pluripotent stem
cells (iPSCs) are disclosed. The RPE is a polarized monolayer in the
vertebrate eye that separates the neural retina from the choroid, and
performs a crucial role in retinal physiology by forming a blood-
retinal barrier and closely interacting with photoreceptors to maintain
visual function. Many ophthalmic diseases, such as age-related macular
degeneration, are associated with a degeneration or deterioration of
the RPE. The iPSCs are produced from somatic cells, including retinal
pigment epithelial cells, such as fetal RPE. These methods involve
producing embryoid bodies from human iPSCs, culturing the embryoid
bodies using specific media to induce differentiation into RPE and
growing the differentiated RPE cells in a defined media to generate
human RPE cells. The investigators also developed methods for detecting
RPE cells and authenticating RPE cells; determining agents that can
affect the production of RPE cells from an iPSC; and identifying an
agent that can increase RPE survival in response to a proteo toxic
insult or stress. The novel methods and RPE cells disclosed here can be
useful for both pre-clinical and clinical studies involving RPE.
Potential Commercial Applications: The methods described here can
be used to:
Produce RPE cells for use in screening for novel ocular
therapeutics and for identifying toxic side effects of drugs.
Produce RPE cells for use in novel cell-based therapies.
Produce cells to study pathophysiology of RPE.
Competitive Advantages: The methods described here:
Dramatically increase the efficiency of iPSC
differentiation into RPE.
Produce superior quality RPE.
Produce RPE cells that are fully authenticated.
Provide ways to perform high throughput screens with RPE
cells.
Development Stage:
Prototype.
Early-stage.
In vitro data available.
Intellectual Property: HHS Reference No. E-251-2012/3--U.S.
Provisional Application No. 61/759,988 filed 01 Feb 2013.
Licensing Contact: Suryanarayana (Sury) Vepa; 301-435-5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity: The National Eye Institute is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
iPSC to RPE differentiation protocol, its clinical, screening, and
translational applications. For collaboration opportunities, please
contact Alan Hubbs, Ph.D. at hubbsa@mail.nih.gov.
Novel Tocopherol and Tocopheryl Quinone Derivatives as Therapeutics for
Lysosomal Storage Disorders
Description of Technology: Novel tocopherol derivatives and
tocopheryl quinone derivatives useful in the decrease of lysosomal
substrate accumulation, the restoration of normal lysosomal size, and
the treatment of lysosomal storage disorders (LSDs) are provided. The
inventors have discovered that tocopherol and tocopheryl quinone
derivatives with side chain modifications (such as terminal tri-
halogenated methyl groups) exhibit improved pharmacokinetics,
modulation of mitochondrial potential and restoration of some LSDs
phenotypes. These molecules by themselves or in combination with
Cyclodextrins (CDs) increase intracellular Ca2+ and enhance exocytosis.
Also, the treatment with these compounds reduced the pathological
changes in the ultrastructure of LSD cells as observed using electron
microscopy analysis. The inventors also found that there is a synergy
between CDs and the new tocopherol analogues when tested on the NPC
cells and cells from six other
[[Page 24758]]
lysosomal storage diseases including Wolman, Niemann Pick Type A,
Farber, TaySachs, MSIIIB and CLN2 (Batten) diseases. These new
tocopherol analogues are as good or better than natural occurring
tocopherols and tocotrienols in reducing cholesterol accumulation in
several LSDs.
Potential Commercial Applications: To develop new therapeutics to
treat LSDs.
Competitive Advantages:
The main advantage of the compounds disclosed here is
their improved pharmacokinetics.
The combination of CD and the novel tocopherol analogues
may reduce the dosage of each drug and thereby reduce the potential
side effects.
Development Stage:
Prototype.
Early-stage.
Pre-clinical.
In vitro data available.
Inventors: Juan Jose Marugan, Wei Zheng, Jingbo Xiao, and John
McKew (NCATS).
Intellectual Property: HHS Reference No. E-148-2012/0--U.S.
Provisional Application No. 61/727,296 filed 16 Nov 2012.
Related Technologies:
HHS Reference No. E-294-2009/0--PCT Application No. PCT/
US2011/044590 filed 19 Jul 2011, which published as WO 2012/012473 on
26 Jan 2012.
HHS Reference No. E-050-2012/0--US Provisional Application
No. 61/679,668 filed 12 Aug 2012.
Licensing Contact: Suryanarayana (Sury) Vepa; 301-435-5020;
vepas@mail.nih.gov.
Collaborative Research Opportunities: The National Center for
Advancing Translational Sciences (NCATS) is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize Novel Tocopherol
and Tocopheryl Quinone Derivatives as Therapeutics for Lysosomal
Storage Disorders. For collaboration opportunities, please contact the
NCATS Technology Development Coordinator at
NCATSPartnerships@mail.nih.gov.
Dated: April 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-09902 Filed 4-25-13; 8:45 am]
BILLING CODE 4140-01-P
