Government-Owned Inventions; Availability for Licensing, 36549-36551 [2011-15467]
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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
METVIXIA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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FDA approved for marketing the
human drug product METVIXIA
(Methyl aminolevulinate
hydrochloride). METVIXIA is indicated
for treatment of thin and moderately
thick, non-hyperkeratotic, nonpigmented actinic keratoses of the face
and scalp in immunocompetent patients
when used in conjunction with lesion
preparation in the physician’s office
when other therapies are considered
medically less appropriate. Subsequent
to this approval, the Patent and
Trademark Office received a patent term
restoration application for METVIXIA
(U.S. Patent No. 6,034,267) from
PhotoCure ASA, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration
and that FDA determine the product’s
regulatory review period. In a letter
dated May 25, 2011, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of METVIXIA represented the
first permitted commercial marketing or
use of the product.
FDA has determined that the
applicable regulatory review period for
METVIXIA is 1,695 days. Of this time,
659 days occurred during the testing
phase of the regulatory review period,
while 1,036 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective:
December 8, 1999. The applicant claims
February 24, 2000, as the date the
investigational new drug application
(IND) became effective. However, FDA
records indicate that the testing phase
began when an earlier IND became
effective on December 8, 1999, which
was 30 days after FDA receipt of the
earlier IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: September 26,
2001. FDA has verified the applicant’s
claim that the new drug application
(NDA) for METVIXIA (NDA 21–415)
was submitted on September 26, 2001.
3. The date the application was
approved: July 27, 2004. FDA has
verified the applicant’s claim that NDA
21–415 was approved on July 27, 2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
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36549
In its application for patent extension,
this applicant seeks 871 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by August 22,
2011. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by December 19, 2011. To meet
its burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 25, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–15625 Filed 6–21–11; 8:45 am]
BILLING CODE 4160–01–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
SUMMARY:
E:\FR\FM\22JNN1.SGM
22JNN1
36550
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
A System for Delivering Embolic
Materials Endovascularly to Patients
Description of Technology: The Public
Health Service seeks commercial
entities interested in licensing patent
rights that pertain to a system for
delivering embolic materials
endovascularly to patients. The system
includes a smart catheter that provides
quantitative feedback to a physician
during embolotherapy. This includes a
detecting portion for measuring flow
velocity (e.g., Doppler tip), amount of
reflux, and amount of embolic particles
(e.g., embolization beads) delivered by
the catheter. A graphical user interface
displays the measured information in
real-time.
Applications:
• Transarterial chemoembolization
• Drug eluting bead
• Intravenous drug delivery
• Drug distribution monitoring
• Real-time imaging
Inventors: Matthew Dreher, Elliot
Levy, Karun Sharma, David Tabriz,
Peter Guion, Ankur Kapoor, Bradford
Wood (all NIHCC).
Patent Status: U.S. Provisional
Application No. 61/486,722 filed 16
May 2011 (HHS Reference No. E–184–
2011/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NIH Clinical Center, Radiology and
Imaging Sciences Department, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize a catheter for
quantitative feedback during
embolotherapy. Please contact Ken
Rose, PhD at 301–435–3132 or
rosek@mail.nih.gov for more
information.
Liver Segmental Anatomy and Analysis
From Vessel and Tumor Segmentation
Description of Technology: The
invention is a novel graph-based
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16:40 Jun 21, 2011
Jkt 223001
method for the automated segmentation
of tumors and major intra-hepatic blood
vessels and identification of the liver
anatomical segments. The method
allows visualization and risk analysis
for interventional planning involving
the liver. The method avoids the
shortcomings of the traditional graph
cuts or intensity-based segmentation
methods by including multi-phase
enhancement modeling and shape
likelihoods. The segmented vessels can
be correctly classified into right, middle
and left hepatic, and right and left portal
veins using a hybrid process that
incorporates anatomical information
and competitive region growing.
Tumors can be detected and segmented
using their differential enhancement
and shape with accuracy comparable to
the reports from the Medical Image
Computing and Computer Assisted
Intervention (MICCAI) liver tumor
segmentation competition. Furthermore,
a vessel tracker allowed fitting planes to
the major hepatic vasculature and
identifying the liver segments according
to the Couinaud atlas. The automated
method can be used in conjunction with
manual and automatic liver
segmentations to perform enhanced
visualization for diagnosis and planning
of interventions.
Applications: To assist in the
visualization, diagnosis and planning of
interventional procedures involving the
liver.
Advantages:
• The method avoids the
shortcomings of the traditional
segmentation methods by including
multi-phase enhancement modeling and
shape likelihoods.
• Tumors are segmented with
accuracy comparable to the reports from
MICCAI liver tumor segmentation
competition.
• Liver segments according to the
Couinaud Atlas are automatically
identified.
• The automated method allows the
enhanced visualization of the liver for
diagnosis and planning of interventions.
Development Status: The algorithm
and software of the method are fully
developed.
Inventors: Marius G. Linguraru and
Bradford J. Wood (NIHCC).
Patent Status: HHS Reference No. E–
178–2011/0—Software/Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Status: A software package
encompassing the method is available
for licensing.
Licensing Contacts:
• Uri Reichman, PhD, MBA; 301–
435–4616; UR7a@nih.gov
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
• Michael Shmilovich, Esq.; 301–
435–5019; shmilovm@mail.nih.gov
Collaborative Research Opportunity:
The NIH Clinical Center, Department of
Radiology and Imaging Sciences, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
techniques for the enhanced
visualization, diagnosis and imagebased interventions of the liver. Please
contact Ken Rose, PhD at 301–435–3132
or rosek@mail.nih.gov for more
information.
MicroRNA–205 for the Treatment and
Diagnosis of Parkinson Disease
Description of Technology: Parkinson
disease (PD) is a devastating
neurodegenerative movement disorder,
pathologically characterized by selective
loss of dopaminergic (DA) neurons in
the substantia nigra pars compacta
(SNpc) and the presence of
intracytoplasmic inclusions named
Lewy bodies and Lewy neurites
(Schapira, Baillieres Clin. Neurol. 6:15–
36, 1997). Increasing numbers of genes
have been identified as a genetic cause
of PD (Hardy et al., Ann. Neurol.
60:389–398, 2006), for example,
multiple missense mutations in the
leucine-rich repeat kinase 2 (LRRK2)
gene were recently found to be
associated with an autosomal dominant
form of familial PD (Paisan-Ruiz et al.,
Neuron 44:595–600, 2004; Zimprich et
al., Neuron 44:601–607, 2004; Zabetian
et al., Neurology 65:741–744, 2005).
Recent genome-wide association studies
(GWAS) also revealed LRRK2, together
with SNCA (encoding a-syn) and
PARK16, as shared risk loci for PD
(Simon-Sanchez et al., Nat. Genet.
41:1308–1312, 2009; Satake et al., Nat.
Genet. 41:1303–1307, 2009), indicating
a potential contribution of normal
LRRK2 protein to the etiology of
sporadic PD cases.
Micro-RNAs (miRNAs or miRs) are
evolutionarily conserved small nonprotein coding transcripts that bind to
partially complementary binding sites
in the 3’ untranslated region (3’-UTR) of
target messenger RNAs (mRNAs) and
control the translation of their target
mRNAs at the post-transcriptional level
(Bartel, Cell 116:281–297, 2004). Several
miRNAs have been associated with
neurodegenerative disease as well as
synaptic plasticity, memory formation
and developmental cell fate decisions in
the nervous system (Hebert and De
Strooper, Trends Neurosci. 32:199–206,
2009; Kosik, Nat. Rev. Neurosci. 7:911–
920, 2006).
NIH inventors have recently
discovered that LRRK2 protein
E:\FR\FM\22JNN1.SGM
22JNN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
expression is significantly increased in
the brain of PD patients, while
expression of miR–205 is specifically
down-regulated in the same patients.
Also, the NIH inventors have discovered
that the expression levels of LRRK2 and
miR–205 are dynamically regulated and
reversely correlated in multiple brain
regions and at different ages in mouse
brains, indicating that miR–205 plays a
regulatory role in LRRK2 protein
expression.
Based on these novel findings, the
present technology provides for novel
methods of treatment of patients
suffering from PD disease by modulating
the amount of miR–205 in patients by
administration of a miR–205 gene
product, a vector encoding a miR–205
gene product or an agent that increases
expression of miR–205. The present
technology also provides for methods of
determining the effectiveness of
different candidate drugs for the
treatment of PD, methods of diagnosing
PD, or having an increased
susceptibility to developing PD, and an
in vitro process for identifying a
therapeutic agent for the treatment of
PD.
Applications: Therapeutics and
diagnostics for PD.
Development Status: Early-stage.
Inventors: Huaibin Cai and Hyun J.
Cho (NIA).
Patent Status: U.S. Provisional
Application No. 61/430,626 filed 07 Jan
2011 (HHS Reference No. E–209–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Suryanarayana
Vepa, PhD, J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute on Aging,
Transgenics Section, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize microRNA–205 or other
reagents for the treatment and diagnosis
of Parkinson Disease. Please contact
Nicole Guyton, PhD at 301–435–3101 or
darackn@mail.nih.gov for more
information.
Dated: June 14, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–15467 Filed 6–21–11; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
16:40 Jun 21, 2011
Jkt 223001
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
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:
Monoclonal Antibodies to Glypican-3
Protein and Heparin Sulfate for
Treatment of Cancer
Description of Technology:
Hepatocellular carcinoma (HCC) is the
most common form of liver cancer, and
is among the more deadly cancers in the
world due to its late detection and poor
prognosis. HCC is often associated with
liver disease, curtailing traditional
chemotherapy as a treatment option.
While surgical resection offers the best
method for long term treatment of the
disease, only a small portion of HCC
patients are eligible for this procedure.
As a result, there is a need for new
treatments that can be successfully
applied to a large population of HCC
patients.
Glypican-3 (GPC3) is a cell surface
protein that is preferentially expressed
on HCC cells. Evidence has
demonstrated that a soluble form of
GPC3 that is incapable of cell signaling
has the ability to inhibit the growth of
HCC cells. This suggested that blocking
GPC3 signaling could serve as a
therapeutic approach for treating HCC.
This invention concerns monoclonal
antibodies against GPC3 and their use,
either by themselves or as the targeting
domain for an immunotoxin, for the
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36551
treatment of GPC3-expressing cancers
such as HCC. Specifically, the inventors
have generated two distinct monoclonal
antibodies to GPC3. The first
monoclonal antibody (HN3) binds to a
conformational epitope on the cell
surface domain of GPC3. The second
monoclonal antibody (HS20) binds
specifically to heparin sulfate chains on
GPC3.
By blocking GPC3 function, these
antibodies can inhibit the growth of
HCC cells, thereby decreasing the ability
of tumors to grow and metastasize.
Furthermore, by using the antibodies to
target a toxin to only those cells that
express GPC3, cancer cells can be
eliminated while allowing healthy,
essential cells to remain unharmed.
Thus, monoclonal antibodies to GPC3
(and corresponding immunotoxins)
represent a novel therapeutic candidate
for treatment of HCC, as well as other
cancers associated with the differential
expression of GPC3.
Applications:
• Therapeutic candidates against
cancers that overexpress GPC3;
• Antibodies for killing cancer cells
by inhibiting GPC3-based cell signaling,
thereby inhibiting tumor cell growth;
• Immunotoxins for killing cancer
cells through the action of a toxic agent;
• Diagnostics for detecting cancers
associated with GPC3 overexpression;
• Specific cancers include
hepatocellular cancer (HCC), melanoma,
thyroid cancer, lung squamous cell
carcinoma, Wilms’ tumor,
neuroblastoma, hepatoblastoma, and
testicular germ-cell tumors.
Advantages:
• Monoclonal antibodies create a
level of specificity that can reduce
deleterious side-effects;
• Multiple treatment strategies
available including the killing of cancer
cells with a toxic agent or by inhibiting
cell signaling;
• Non-invasive and potentially nonliver toxic alternative to current HCC
treatment strategies.
Development Status: Preclinical stage
of development; cell culture data with
HCC cells.
Inventors: Mitchell Ho (NCI) et al.
Patent Status: U.S. provisional
application 61/477,020 (HHS
technology reference E–130–2011/0–
US–01).
For more information, see:
• M Feng et al. Recombinant soluble
glypican 3 protein inhibits the growth of
hepatocellular carcinoma in vitro. Int J
Cancer 2011 May1;128(9):2246–2247,
doi 10.1002/ijc.25549. [PMID:
20617511].
• SI Zitterman et al. Soluble glypican
3 inhibits the growth of hepatocellular
E:\FR\FM\22JNN1.SGM
22JNN1
]]>Agencies
[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36549-36551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15467]
-----------------------------------------------------------------------
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
[[Page 36550]]
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.
A System for Delivering Embolic Materials Endovascularly to Patients
Description of Technology: The Public Health Service seeks
commercial entities interested in licensing patent rights that pertain
to a system for delivering embolic materials endovascularly to
patients. The system includes a smart catheter that provides
quantitative feedback to a physician during embolotherapy. This
includes a detecting portion for measuring flow velocity (e.g., Doppler
tip), amount of reflux, and amount of embolic particles (e.g.,
embolization beads) delivered by the catheter. A graphical user
interface displays the measured information in real-time.
Applications:
Transarterial chemoembolization
Drug eluting bead
Intravenous drug delivery
Drug distribution monitoring
Real-time imaging
Inventors: Matthew Dreher, Elliot Levy, Karun Sharma, David Tabriz,
Peter Guion, Ankur Kapoor, Bradford Wood (all NIHCC).
Patent Status: U.S. Provisional Application No. 61/486,722 filed 16
May 2011 (HHS Reference No. E-184-2011/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The NIH Clinical Center,
Radiology and Imaging Sciences Department, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize a catheter for
quantitative feedback during embolotherapy. Please contact Ken Rose,
PhD at 301-435-3132 or rosek@mail.nih.gov for more information.
Liver Segmental Anatomy and Analysis From Vessel and Tumor Segmentation
Description of Technology: The invention is a novel graph-based
method for the automated segmentation of tumors and major intra-hepatic
blood vessels and identification of the liver anatomical segments. The
method allows visualization and risk analysis for interventional
planning involving the liver. The method avoids the shortcomings of the
traditional graph cuts or intensity-based segmentation methods by
including multi-phase enhancement modeling and shape likelihoods. The
segmented vessels can be correctly classified into right, middle and
left hepatic, and right and left portal veins using a hybrid process
that incorporates anatomical information and competitive region
growing. Tumors can be detected and segmented using their differential
enhancement and shape with accuracy comparable to the reports from the
Medical Image Computing and Computer Assisted Intervention (MICCAI)
liver tumor segmentation competition. Furthermore, a vessel tracker
allowed fitting planes to the major hepatic vasculature and identifying
the liver segments according to the Couinaud atlas. The automated
method can be used in conjunction with manual and automatic liver
segmentations to perform enhanced visualization for diagnosis and
planning of interventions.
Applications: To assist in the visualization, diagnosis and
planning of interventional procedures involving the liver.
Advantages:
The method avoids the shortcomings of the traditional
segmentation methods by including multi-phase enhancement modeling and
shape likelihoods.
Tumors are segmented with accuracy comparable to the
reports from MICCAI liver tumor segmentation competition.
Liver segments according to the Couinaud Atlas are
automatically identified.
The automated method allows the enhanced visualization of
the liver for diagnosis and planning of interventions.
Development Status: The algorithm and software of the method are
fully developed.
Inventors: Marius G. Linguraru and Bradford J. Wood (NIHCC).
Patent Status: HHS Reference No. E-178-2011/0--Software/Research
Tool. Patent protection is not being pursued for this technology.
Licensing Status: A software package encompassing the method is
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 NIH Clinical Center,
Department of Radiology and Imaging Sciences, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize techniques for
the enhanced visualization, diagnosis and image-based interventions of
the liver. Please contact Ken Rose, PhD at 301-435-3132 or
rosek@mail.nih.gov for more information.
MicroRNA-205 for the Treatment and Diagnosis of Parkinson Disease
Description of Technology: Parkinson disease (PD) is a devastating
neurodegenerative movement disorder, pathologically characterized by
selective loss of dopaminergic (DA) neurons in the substantia nigra
pars compacta (SNpc) and the presence of intracytoplasmic inclusions
named Lewy bodies and Lewy neurites (Schapira, Baillieres Clin. Neurol.
6:15-36, 1997). Increasing numbers of genes have been identified as a
genetic cause of PD (Hardy et al., Ann. Neurol. 60:389-398, 2006), for
example, multiple missense mutations in the leucine-rich repeat kinase
2 (LRRK2) gene were recently found to be associated with an autosomal
dominant form of familial PD (Paisan-Ruiz et al., Neuron 44:595-600,
2004; Zimprich et al., Neuron 44:601-607, 2004; Zabetian et al.,
Neurology 65:741-744, 2005). Recent genome-wide association studies
(GWAS) also revealed LRRK2, together with SNCA (encoding [alpha]-syn)
and PARK16, as shared risk loci for PD (Simon-Sanchez et al., Nat.
Genet. 41:1308-1312, 2009; Satake et al., Nat. Genet. 41:1303-1307,
2009), indicating a potential contribution of normal LRRK2 protein to
the etiology of sporadic PD cases.
Micro-RNAs (miRNAs or miRs) are evolutionarily conserved small non-
protein coding transcripts that bind to partially complementary binding
sites in the 3' untranslated region (3'-UTR) of target messenger RNAs
(mRNAs) and control the translation of their target mRNAs at the post-
transcriptional level (Bartel, Cell 116:281-297, 2004). Several miRNAs
have been associated with neurodegenerative disease as well as synaptic
plasticity, memory formation and developmental cell fate decisions in
the nervous system (Hebert and De Strooper, Trends Neurosci. 32:199-
206, 2009; Kosik, Nat. Rev. Neurosci. 7:911-920, 2006).
NIH inventors have recently discovered that LRRK2 protein
[[Page 36551]]
expression is significantly increased in the brain of PD patients,
while expression of miR-205 is specifically down-regulated in the same
patients. Also, the NIH inventors have discovered that the expression
levels of LRRK2 and miR-205 are dynamically regulated and reversely
correlated in multiple brain regions and at different ages in mouse
brains, indicating that miR-205 plays a regulatory role in LRRK2
protein expression.
Based on these novel findings, the present technology provides for
novel methods of treatment of patients suffering from PD disease by
modulating the amount of miR-205 in patients by administration of a
miR-205 gene product, a vector encoding a miR-205 gene product or an
agent that increases expression of miR-205. The present technology also
provides for methods of determining the effectiveness of different
candidate drugs for the treatment of PD, methods of diagnosing PD, or
having an increased susceptibility to developing PD, and an in vitro
process for identifying a therapeutic agent for the treatment of PD.
Applications: Therapeutics and diagnostics for PD.
Development Status: Early-stage.
Inventors: Huaibin Cai and Hyun J. Cho (NIA).
Patent Status: U.S. Provisional Application No. 61/430,626 filed 07
Jan 2011 (HHS Reference No. E-209-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Suryanarayana Vepa, PhD, J.D.; 301-435-5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity: The National Institute on
Aging, Transgenics Section, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize microRNA-205 or other reagents for
the treatment and diagnosis of Parkinson Disease. Please contact Nicole
Guyton, PhD at 301-435-3101 or darackn@mail.nih.gov for more
information.
Dated: June 14, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-15467 Filed 6-21-11; 8:45 am]
BILLING CODE 4140-01-P
