Government-Owned Inventions; Availability for Licensing, 53433-53437 [E8-21519]
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efficiency, high throughput systems for
protein production or analysis at lower
cost and ease of scale-up would be
potential licensors of this technology.
Development Status: Late Stage—
Ready for Production.
Inventors: Joseph Shiloach (NIDDK),
Pratik Jaluria (NIDDK).
Related Publication: P. Jaluria et al.
Application of microarrays to identify
and characterize genes involved in
attachment dependence in HeLa cells.
Metab Eng. 2007 May;9(3):241–251.
Patent Status: PCT Application No.
PCT/US2007/018699 filed 24 Aug 2007,
which published as WO 2008/024459
on 28 Feb 2008; claiming priority to 24
Aug 2006 (HHS Reference No. E–149–
2006/2–PCT–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases,
Biotechnology Core Laboratory, is
seeking parties interested in
collaborative research projects directed
toward the use of this technology with
cells for drug and vaccine production
and development, including growth
optimization, production and product
recovery processes. For more
information, please contact Dr. Joseph
Shiloach, josephs@intra.niddk.nih.gov,
or Rochelle S. Blaustein at
Rochelle.Blaustein@nih.gov.
In Vitro Model for Hepatitis C Virion
Production
Description of Technology: This
invention provides an in vitro hepatitis
C virus (HCV) replication system that is
capable of producing viral particles in a
culture medium. Hepatitis C is a major
public health problem, the development
of therapeutics for which has been
hampered by a lack of a robust model
system to study the complete viral life
cycle. This invention provides a new
model system for the complete
replication cycle of hepatitis C virus and
virion production, assembly and release.
The model is useful for screening
antiviral agents against HCV.
A full length HCV construct, CG1b of
genotype 1b which is known to be
infectious, was placed between two
ribozymes designed to generate the
exact 5′ and 3′ ends of HCV when
cleaved. Using this system, HCV
proteins and positive and negative RNA
strands have been shown to reproduce
intracellularly, and viral particles that
resemble authentic HCV virions are
produced and secreted into the culture
medium.
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The patent application includes
claims directed toward the following: A
construct comprising specific nucleic
acid sequences including HCV genotype
1b, genotype 1a, genotype 2a or
potentially other genotypes; a method
for identifying a cell line that is
permissive for infection with HCV; a
method for propagating HCV in vitro; a
method for screening agents capable of
modulating HCV replication or activity;
a method for testing the level of HCV
replication or activity; a HCV vaccine
comprising HCV virus particles.
Applications: The model offers a
novel method for investigating the
entire HCV life cycle including
replication and pathogenesis and is
useful for high-throughput antiviral
screening. This technique may also be
useful for making infectious particles
that are useful in the production of HCV
vaccines.
Advantages: This system provides a
new, stable and efficient cell culture
model to further study the life cycle and
biology of HCV, and to test potential
therapeutic targets for hepatitis C. This
model has also been used to generate in
cell culture HCV strains infectious for
chimpanzees, the only experimental
animal susceptible to infection with the
hepatitis C virus, a critical step in the
development of new vaccines for
Hepatitis C.
Market: Hepatitis C virus (HCV)
chronically infects approximately 200
million people worldwide and increases
the risk of developing cirrhosis and
hepatocellular carcinoma. This
technology would be useful for studying
the HCV life cycle, screening for
therapeutic agents against multiple HCV
strains, including Genotype 1a, 1b and
2a, and the development of HCV
vaccines. HCV genotypes 1 and 2 are the
major genotypes with worldwide
distribution; they are known to be
associated with different clinical
profiles and therapeutic responses.
Hence, the model may be used to screen
for varying levels of effectiveness of
therapeutics against the major HCV
genotypes.
Development Status: This technology
is available for use in diagnostics, drug/
vaccine discovery, production and
development. Current work is directed
toward studies into the HCV life cycle
and replication and the pathogenesis of
HCV screening for antiviral agents
against multiple HCV strains. This
model has been used to generate in cell
culture HCV strains infectious for
chimpanzees, the only experimental
animal susceptible to infection with the
hepatitis C virus, a critical step in the
development of new vaccines for
Hepatitis C. Future work may be
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directed toward the use of this system
for development of vaccine candidates
against HCV.
Inventors: T. Jake Liang and Theo
Heller (NIDDK).
Related Publications:
1. Z. Hu et al. Altered proteolysis and
global gene expression in hepatitis B
virus X transgenic mouse liver. J Virol.
2006 Feb;80(3):1405–1413.
2. T. Heller et al. An in vitro model
of hepatitis C virion production. Proc
Natl Acad Sci USA. 2005 Feb
15;102(7):2579–2583.
Patent Status: U.S. Patent Application
No. 11/664,375 filed 30 Mar 2007,
claiming priority to 30 Sep 2004 (HHS
Reference No. E–324–2004/3–US–02).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases, Liver
Diseases Branch, is seeking parties
interested in collaborative research
directed toward molecular strategies for
vaccine and antiviral development, and
animal models of viral hepatitis C. For
more information, please contact Dr. T.
Jake Liang at 301–496–1721 or
jliang@nih.gov or Rochelle S. Blaustein
at Rochelle.Blaustein@nih.gov.
Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–21507 Filed 9–15–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
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Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices
Cyclized NGR Peptide for Tumor
Targeting
Description of Technology: Available
for licensing and commercial
development are patent rights and
materials related to NGR peptides for
targeting therapeutic and diagnostic
agents to cancer cells. Specifically
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Applications:
•
•
•
•
Cancer diagnostics
Cancer therapeutics
Anti-angiogenesis
Imaging
Inventors: Bradford Wood, Matthew
Dreher, Ayele Negussie (CC).
Relevant Publications:
1. W Arap et al. Cancer treatment by
targeted drug delivery to tumor
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targeted are tumors that express
aminopeptidase N isoform CD13. NGR
peptides include the Asn-Gly-Arg
peptide motif, a ligand for APN/CD13.
NGR-containing peptides have been
proven useful for delivering cytotoxic
drugs, apoptotic peptides, and cytokines
(such as tumor necrosis factor (TNF)) to
tumor vasculature. In some
embodiments of the invention, the NGR
peptide is conjugated with a diagnostic
moiety such as a fluorophore,
nonmetallic isotope, an optical reporter,
a boron neutron absorber, a
paramagnetic metal ion, a ferromagnetic
metal, a gamma-emitting radioisotope, a
positron-emitting radioisotope, or an xray absorber. In another embodiment,
the peptide can be conjugated with a
therapeutic such as daunorubicin,
doxorubicin, epirubicin, idarubicin,
mitoxantrone, or a combination of these.
The therapeutic agent, such as an antitumor or anti-neoplastic agent of choice,
can be entrapped within a liposome; the
liposomes are formulated to be of a size
known to penetrate the endothelial and
basement membrane barriers. The
resulting liposomal formulation can be
administered parenterally to a subject in
need of such treatment, preferably by
intravenous administration. Tumors
characterized by an acute increase in
permeability of the vasculature in the
region of tumor growth are particularly
suited for treatment by the present
invention.
vasculature in a mouse model. Science.
1998 Jan 16;279(5349):377–380.
2. H Ellerby et al. Anti-cancer activity
of targeted pro-apoptotic peptides. Nat
Med. 1999 Sep;5(9):1032–1038.
3. F Curnis et al. Enhancement of
tumor necrosis factor alpha antitumor
immunotherapeutic properties by
targeted delivery to aminopeptidase N
(CD13). Nat Biotechnol. 2000
Nov;18(11):1185–1190.
4. G Colombo et al. Structure-activity
relationships of linear and cyclic
peptides containing the NGR tumorhoming motif. J Biol Chem. 2002 Dec
6;277(49):47891–47897.
5. F Pastorino et al. Vascular damage
and anti-angiogenic effects of tumor
vessel-targeted liposomal
chemotherapy. Cancer Res. 2003 Nov
1;63(21):7400–7409.
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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.
Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices
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6. F Pastorino et al. Targeting
liposomal chemotherapy via both tumor
cell-specific and tumor vasculaturespecific ligands potentiates therapeutic
efficacy. Cancer Res. 2006 Oct
15;66(20):10073–10082.
7. SV Garde et al. Binding and
internalization of NGR-peptide-targeted
liposomal doxorubicin (TVT–DOX) in
CD13-expressing cells and its antitumor
effects. Anti-Cancer Drugs. 2007
Nov;18(10):1189–1200.
Patent Status: U.S. Provisional
Application No. 61/074,864 filed 23 Jun
2008 (HHS Reference No. E–147–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Microfabricated Particles Useful as
MRI Contrast Agents
Description of Technology: MRI
contrast agents are versatile yet lack the
sensitivity and multiplexing capabilities
of optical agents. Available for licensing
is an invention pertaining to
microfabricated structures that can be
used as MRI contrast agents with
enhanced functionality or as microRFID (radio-frequency identification)
tags. The microstructures can be
engineered to appear as different
effective colors when resolved using
MRI as opposed to strictly grey-scale
contrast of existing MRI agents. In this
way they can be thought as radiofrequency analogs to quantum dots. A
set of agents could be produced that
would enable in vivo labeling and
tracking of multiple different types of
cells simultaneously. The agents can
also act as radio-frequency probes of
various physiological conditions. The
invention can include a plurality of
microstructures dispersed a liquid. The
structures can have magnetic portions
that vary in size, thickness and shape
that are arranged to provide a
substantially uniform Larmor precession
frequency or a characteristic
substantially uniform shift in Larmor
precession frequency experienced by
nuclear magnetic moments of a material
when it is located in the substantially
uniform field region created by the
magnetic portions. In some
embodiments, each of the nuclear
magnetic resonance microstructures has
a maximum dimension less than about
1 mm. The magnetic portions of the
microstructure can be arranged
proximate to each other, in contact with
each other or be partially, substantially
or totally coincident.
Applications:
• Magnetic Resonance Imaging
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•
•
•
•
•
•
Cancer
Cardiovascular diseases imaging
Drug development
Drug candidate distribution tracking
Diagnostics
Microfluidics
Inventors: Gary Zabow, Stephen Dodd
(NINDS), Alan Koretsky (NINDS), John
Moreland (NIST).
Publications:
1. G Zabow et al. Micro-engineered
local field control for high-sensitivity
multispectral MRI. Nature 2008 Jun
19;453(7198):1058–1063.
2. KA Hinds et al. Highly efficient
endosomal labeling of progenitor and
stem cells with large magnetic particles
allows magnetic resonance imaging of
single cells. Blood 2003 Aug
1;102(3):867–872.
Patent Status: U.S. Provisional
Application No. 61/071,263 filed 18 Apr
2008 (HHS Reference No. E–081–2008/
0-US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
NINDS Laboratory of Functional and
Molecular Imaging is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the use of
microfabricated devices as MRI contrast
agents. Please contact Dr. Melissa
Maderia at 301–451–3943 or
maderiam@mail.nih.gov for more
information.
Active Guidewire Visualization Device
and System for MRI Guided
Interventions
Description of Technology: Available
for licensing and commercial
development is a guidewire device and
system for MRI guidance of vascular
interventions. The guidewire design,
and its coupled system, enables
interventionalists to visualize the
location of the tip and distal shaft of an
MRI compatible guidewire relative to
the vascular system and surrounding
anatomy. Visualization of both the shaft
and tip enables interventionalists to
advance the guidewire through tortuous
vessels reducing the risk of puncturing
vessel walls and also steering it through
labyrinthine vasculature. The guidewire
provided by the present invention
includes distal and proximal ends with
a space therein, a dipole antenna
disposed in the space reserved within
the guidewire body, the dipole antenna
being adapted to be electrically
connected to a signal processing system
through a first signal channel through
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the proximal end of the guidewire body,
and a loop antenna disposed in the
space reserved within the guidewire
body toward the distal end of the
guidewire body, the loop antenna being
adapted to be electrically connected to
the signal processing system through a
second signal channel through the
proximal end of the guidewire body.
The dipole antenna and the loop
antenna are each constructed to receive
magnetic resonance imaging signals
independently of each other and to
transmit received signals through the
first and second signal channels,
respectively, to be received by the signal
processing system. More specifically,
both loop and dipole antenna are tuned
to resonate at the same Larmour
frequency as produced by the magnet.
Applications:
• Interventional cardiology
• MRI guided surgery
Inventors: Ozgur Kocaturk (NHLBI).
Publications:
1. McKinnon GC, et al. Towards
active guidewire visualization in
interventional magnetic resonance
imaging. MAGMA. 1996 Mar;4(1):13–18.
2. Ladd ME, et al. Active MR
visualization of a vascular guidewire in
vivo. J Magn Reson Imaging. 1998 JanFeb;8(1):220–225.
Patent Status: U.S. Provisional
Application No. 61/006,265 filed 03 Jan
2008 (HHS Reference No. E–209–2007/
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 National Institutes of Health /
Cardiac Catheter Core Lab is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize Active two channel
0.035″ guidewire. Please contact Ozgur
Kocaturk at 301–402–9430 or
kocaturko@nhlbi.nih.gov.
Respiratory Syncytial Virus (RSV)
Vaccines Based on Promoter-Proximate
Attenuation
Description of Technology: Available
for licensing and commercial
development is a patent estate and
related biological materials for
producing therapeutic or prophylactic
vaccines against Respiratory Syncytial
Virus (RSV). The claimed vaccine
strategy relates to the engineering and
creation of live-attenuated RSV vaccine
candidates by shifting the position of
one or more viral genes relative to the
viral promoter (aka promoter-proximal
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attenuation). The gene shifts can be
constructed by insertion, deletion or
rearrangement of genes or genome
segments within the recombinant
genome or antigenome. Viral replication
can increase or decrease depending on
the position of expressed viral gene and
depending on the nature and degree of
the positional shift. Viral gene
rearrangements are selected to maintain
sufficient non-infectious replication of
RSV while eliciting host anti-RSV
immune responses. Viral genes targeted
for such rearrangement include any of
the NS1, NS2, N, P, M, SH, M2(ORF1),
M2(ORF2), L, F or G genes or genome
segment.
One modification of particular
interest is the placement of the G and F
protective antigen genes in a promoterproximal position for increased
expression. The gene position-shifted
RSV can be further manipulated by the
addition of specific nucleotide and
amino acid point mutations or host
range restriction determinants to yield
desired phenotypic and structural
effects.
Applications:
• Infectious Disease—Respiratory
Syncytial Virus
• Vaccines
• Therapeutics
• Prophylactics
• Childhood Vaccines
Inventors: Christine D. Krempl, Peter
L. Collins, Brian R. Murphy, Ursula
Buchholz, Stephen S. Whitehead
(NIAID)
Publications:
1. C Krempl et al. Recombinant
respiratory syncytial virus with the G
and F genes shifted to the promoterproximal positions. J Virol. 2002
Dec;76(23):11931–11942.
2. Y Aloni, N Hay. Attenuation may
regulate gene expression in animal
viruses and cells. CRC Crit Rev
Biochem. 1985;18(4):327–383.
Patent Status:
HHS Reference No. E–225–2000/0—
• U.S. Patent No. 6,923,971 issued 02
Aug 2005
• U.S. Patent Application No. 11/
033,055 filed 10 Jan 2005
• U.S. Patent Application No. 11/
054,343 filed 08 Feb 2005
• International Patent Application
PCT/US2001/20107, which
published as WO 2002/00693 on 03
Jan 2002 (expired)
• Australian Patent 2001268709
• Brazilian Patent Application
PI0112276–2
• Canadian Patent Application
2413786
• Chinese Patent Application
01814362.8
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• European Patent Application
01946696.0
• Israeli Patent Application 153530
• Japanese Patent Application 10–
2002–505815
• Korean Patent Application 10–
2002–7017577 and
• Mexican Patent Application 2002–
012818.
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Office of Technology
Development is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize live attenuated vaccines.
Please contact Michael Piziali at 301–
451–3527 for more information.
Quantitative Assessment of Changes in
Tissue Status in Disease, Development,
Aging, or Degeneration Using Diffusion
Tensor Magnetic Resonance Imaging
Description of Technology: This
invention significantly enhances the
quality and utility of diffusion tensor
magnetic resonance imaging (DT-MRI)
data. The patent application for the
invention describes quantitative
statistical methodology to extract novel
clinical and biological information from
DT-MRI data. These parametric and
non-parametric statistical methods help
distinguish changes in tissue state from
background noise inherent in all MRI
measurements. The invention also
includes hypothesis tests to determine
the statistical significance of changes
observed in MRI ‘‘stains’’ (e.g., the Trace
of the diffusion tensor, Trace(D), and the
mean apparent diffusion coefficient,
ADC), which are widely used in the
diagnosis of stroke. Further, this
invention describes how to detect
systematic artifacts in each pixel of a
diffusion weighted image (e.g., artifacts
caused by patient motion). Indeed, this
new statistical methodology for
analyzing and interpreting diffusion
tensor MRI data should improve the
efficacy of drug screening studies, as
well as streamline multi-site and
longitudinal studies designed to assess
the safety and efficacy of drugs
undergoing clinical evaluation.
Inventors: Peter J. Basser (NICHD),
Sinisa Pajevic (CIT).
Patent Status: U.S. Patent No.
6,845,324 issued 15 Jan 2005 (HHS
Reference No. E–192–1999/0-US–07)
Licensing Status: Available for
licensing.
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Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Human-Bovine Chimeric Respiratory
Syncytial Virus (RSV) Vaccines
Description of Technology: Available
for licensing and commercial
development is a patent estate and
related biological materials for making
human-bovine chimeric virus particles
for formulating live attenuated vaccines
against human respiratory syncytial
virus (RSV). Chimeric human-bovine
RSVs are recombinantly engineered to
incorporate nucleotide sequences from
both human and bovine RSV strains and
produce infectious, chimeric viruses
that elicit anti-RSV immunological
responses in humans and non-human
primates. The chimeras incorporate
partial or complete human or bovine
RSV background genomes with one or
more recombinantly integrated
heterologous genes or genome segments
of a different RSV strain.
Heterologous genes of interest for
making chimeric recombinants include
NS1, NS2, N, P, M, SH glycoprotein (or
an immunogenic domain or epitope
thereof), M2(ORF1), M2(ORF2), L, F or
G genes or a genome segment including
a protein or portion thereof or
alternatively a leader, trailer or
intergenic region of the RSV genome, or
a segment thereof. A variety of
additional mutations and nucleotide
modifications are provided within the
human-bovine chimeric RSV of the
invention to yield desired phenotypic
and structural effects. Exemplary
human-bovine chimeric RSV of the
invention incorporate a chimeric RSV
genome or antigenome comprising both
human and bovine polynucleotide
sequences, as well as a major
nucleocapsid (N) protein, a
nucleocapsid phosphoprotein (P), a
large polymerase protein (L), and an
RNA polymerase elongation factor.
Additional RSV proteins may be
included in various combinations to
provide a range of infectious subviral
particles up to a complete viral particle
or a viral particle containing
supernumerary proteins, antigenic
determinants or other additional
components.
Applications:
• Infectious Disease—Respiratory
Syncytial Virus
• Vaccines
• Therapeutics
• Prophylactics
• Childhood Vaccines
Inventors: Ursula Buchholz, Peter L.
Collins, Brian R. Murphy, Stephen S.
Whitehead, Christine D. Krempl
(NIAID).
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Publications:
1. UJ Buchholz et al. Chimeric bovine
respiratory syncytial virus with
glycoprotein gene substitutions from
human respiratory syncytial virus
(HRSV): effects on host range and
evaluation as a live-attenuated HRSV
vaccine. J Virol. 2000 Feb;74(3):1187–
1199.
2. A Karger et al. Recombinant bovine
respiratory syncytial virus with
deletions of the G or SH genes: G and
F proteins bind heparin. J Gen Virol.
2001 Mar;82(Pt 3):631–640.
3. UJ Buchholz et al. Generation of
bovine respiratory syncytial virus
(BRSV) from cDNA: BRSV NS2 is not
essential for virus replication in tissue
culture, and the human RSV leader
region acts as a functional BRSV
genome promoter. J Virol. 1999
Jan;73(1):251–259.
Patent Status:
HHS Reference No. E–178–1999/0—
• International Patent Application
PCT/US00/17755, which published
as WO 2001/04335 on 09 Jan 2001
(expired)
• Australian Patent 784216
• Chinese Patent 00810119.1
• Canadian Patent Application
2378552
• European Patent Application
00941756.9
• Israeli Patent Application 147447
• Japanese Patent Application 2001–
509539
• Korean Patent Application 10–
2002–7000318
• Mexican Patent Application 2002–
000220
• Brazilian Patent Application
PI0013195–4 and
• Chinese Patent Application
200710167112.6
HHS Reference No. E–178–1999/1—
• U.S. Patent Application No. 11/
097,946 filed 31 Mar 2005
HHS Reference No. E–178–1999/2—
• U.S. Patent Application No. 10/
704,116 filed 07 Nov 2003
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Office of Technology
Development is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize attenuated live vaccines
against respiratory syncytial virus
(RSV). Please contact Barry Buchbinder
at 301–594–1696 for more information.
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Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–21519 Filed 9–15–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Cancer Institute Director’s
Consumer Liaison Group.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Cancer
Institute Director’s Consumer Liaison Group.
Date: October 14–15, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: (1) Approval of Minutes; (2)
Report from Dr. John Niederhuber, NCI
Director; (3) Report on the OAR; (4) Report
from Planning & Office of Governmental &
Congressional Relations OD/NCI; (5) Indian
Health Service & Cancer Issues of Native
Americans; (6) Cancer Health
Communications; (7) Update-NCI
Community Cancer Clinics Program; (8)
Reports from DCLG Working Groups &
Member Updates; (9) Public Comment; (10)
Action Items/Conclusion.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Shannon K. Bell, MSW,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 31
Center Drive, Building 31, Room 10A30D,
Bethesda, MD 20892, 301–451–3393.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
53437
deainfo.nci.nih.gov/advisory/dclg/dclg.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: September 9, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–21499 Filed 9–15–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Cancer Institute Board of
Scientific Advisors.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Cancer
Institute Board of Scientific Advisors.
Date: November 6–7, 2008.
Time: November 6, 2008, 8 a.m. to 6 p.m.
Agenda: Director’s Report: Ongoing and
New Business; Reports of Program Review
Group(s); and Budget Presentation; Reports of
Special Initiatives; RFA and RFP Concept
Reviews; and Scientific Presentations.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
Time: November 7, 2008, 8:30 a.m. to
12 p.m.
Agenda: Reports of Special Initiatives; RFA
and RFP Concept Reviews; and Scientific
Presentations.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
Contact Person: Paulette S. Gray, PhD,
Executive Secretary, Director, Division of
Extramural Activities, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Rm. 8001,
Bethesda, MD 20892, 301–496–5147,
grayp@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[Federal Register Volume 73, Number 180 (Tuesday, September 16, 2008)]
[Notices]
[Pages 53433-53437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21519]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications
[[Page 53434]]
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.
Cyclized NGR Peptide for Tumor Targeting
Description of Technology: Available for licensing and commercial
development are patent rights and materials related to NGR peptides for
targeting therapeutic and diagnostic agents to cancer cells.
Specifically targeted are tumors that express aminopeptidase N isoform
CD13. NGR peptides include the Asn-Gly-Arg peptide motif, a ligand for
APN/CD13. NGR-containing peptides have been proven useful for
delivering cytotoxic drugs, apoptotic peptides, and cytokines (such as
tumor necrosis factor (TNF)) to tumor vasculature. In some embodiments
of the invention, the NGR peptide is conjugated with a diagnostic
moiety such as a fluorophore, nonmetallic isotope, an optical reporter,
a boron neutron absorber, a paramagnetic metal ion, a ferromagnetic
metal, a gamma-emitting radioisotope, a positron-emitting radioisotope,
or an x-ray absorber. In another embodiment, the peptide can be
conjugated with a therapeutic such as daunorubicin, doxorubicin,
epirubicin, idarubicin, mitoxantrone, or a combination of these. The
therapeutic agent, such as an anti-tumor or anti-neoplastic agent of
choice, can be entrapped within a liposome; the liposomes are
formulated to be of a size known to penetrate the endothelial and
basement membrane barriers. The resulting liposomal formulation can be
administered parenterally to a subject in need of such treatment,
preferably by intravenous administration. Tumors characterized by an
acute increase in permeability of the vasculature in the region of
tumor growth are particularly suited for treatment by the present
invention.
[GRAPHIC] [TIFF OMITTED] TN16SE08.029
Applications:
Cancer diagnostics
Cancer therapeutics
Anti-angiogenesis
Imaging
Inventors: Bradford Wood, Matthew Dreher, Ayele Negussie (CC).
Relevant Publications:
1. W Arap et al. Cancer treatment by targeted drug delivery to
tumor vasculature in a mouse model. Science. 1998 Jan 16;279(5349):377-
380.
2. H Ellerby et al. Anti-cancer activity of targeted pro-apoptotic
peptides. Nat Med. 1999 Sep;5(9):1032-1038.
3. F Curnis et al. Enhancement of tumor necrosis factor alpha
antitumor immunotherapeutic properties by targeted delivery to
aminopeptidase N (CD13). Nat Biotechnol. 2000 Nov;18(11):1185-1190.
4. G Colombo et al. Structure-activity relationships of linear and
cyclic peptides containing the NGR tumor-homing motif. J Biol Chem.
2002 Dec 6;277(49):47891-47897.
5. F Pastorino et al. Vascular damage and anti-angiogenic effects
of tumor vessel-targeted liposomal chemotherapy. Cancer Res. 2003 Nov
1;63(21):7400-7409.
[[Page 53435]]
6. F Pastorino et al. Targeting liposomal chemotherapy via both
tumor cell-specific and tumor vasculature-specific ligands potentiates
therapeutic efficacy. Cancer Res. 2006 Oct 15;66(20):10073-10082.
7. SV Garde et al. Binding and internalization of NGR-peptide-
targeted liposomal doxorubicin (TVT-DOX) in CD13-expressing cells and
its antitumor effects. Anti-Cancer Drugs. 2007 Nov;18(10):1189-1200.
Patent Status: U.S. Provisional Application No. 61/074,864 filed 23
Jun 2008 (HHS Reference No. E-147-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Microfabricated Particles Useful as MRI Contrast Agents
Description of Technology: MRI contrast agents are versatile yet
lack the sensitivity and multiplexing capabilities of optical agents.
Available for licensing is an invention pertaining to microfabricated
structures that can be used as MRI contrast agents with enhanced
functionality or as micro-RFID (radio-frequency identification) tags.
The microstructures can be engineered to appear as different effective
colors when resolved using MRI as opposed to strictly grey-scale
contrast of existing MRI agents. In this way they can be thought as
radio-frequency analogs to quantum dots. A set of agents could be
produced that would enable in vivo labeling and tracking of multiple
different types of cells simultaneously. The agents can also act as
radio-frequency probes of various physiological conditions. The
invention can include a plurality of microstructures dispersed a
liquid. The structures can have magnetic portions that vary in size,
thickness and shape that are arranged to provide a substantially
uniform Larmor precession frequency or a characteristic substantially
uniform shift in Larmor precession frequency experienced by nuclear
magnetic moments of a material when it is located in the substantially
uniform field region created by the magnetic portions. In some
embodiments, each of the nuclear magnetic resonance microstructures has
a maximum dimension less than about 1 mm. The magnetic portions of the
microstructure can be arranged proximate to each other, in contact with
each other or be partially, substantially or totally coincident.
Applications:
Magnetic Resonance Imaging
Cancer
Cardiovascular diseases imaging
Drug development
Drug candidate distribution tracking
Diagnostics
Microfluidics
Inventors: Gary Zabow, Stephen Dodd (NINDS), Alan Koretsky (NINDS),
John Moreland (NIST).
Publications:
1. G Zabow et al. Micro-engineered local field control for high-
sensitivity multispectral MRI. Nature 2008 Jun 19;453(7198):1058-1063.
2. KA Hinds et al. Highly efficient endosomal labeling of
progenitor and stem cells with large magnetic particles allows magnetic
resonance imaging of single cells. Blood 2003 Aug 1;102(3):867-872.
Patent Status: U.S. Provisional Application No. 61/071,263 filed 18
Apr 2008 (HHS Reference No. E-081-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: NINDS Laboratory of Functional
and Molecular Imaging is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize the use of microfabricated devices as MRI
contrast agents. Please contact Dr. Melissa Maderia at 301-451-3943 or
maderiam@mail.nih.gov for more information.
Active Guidewire Visualization Device and System for MRI Guided
Interventions
Description of Technology: Available for licensing and commercial
development is a guidewire device and system for MRI guidance of
vascular interventions. The guidewire design, and its coupled system,
enables interventionalists to visualize the location of the tip and
distal shaft of an MRI compatible guidewire relative to the vascular
system and surrounding anatomy. Visualization of both the shaft and tip
enables interventionalists to advance the guidewire through tortuous
vessels reducing the risk of puncturing vessel walls and also steering
it through labyrinthine vasculature. The guidewire provided by the
present invention includes distal and proximal ends with a space
therein, a dipole antenna disposed in the space reserved within the
guidewire body, the dipole antenna being adapted to be electrically
connected to a signal processing system through a first signal channel
through the proximal end of the guidewire body, and a loop antenna
disposed in the space reserved within the guidewire body toward the
distal end of the guidewire body, the loop antenna being adapted to be
electrically connected to the signal processing system through a second
signal channel through the proximal end of the guidewire body. The
dipole antenna and the loop antenna are each constructed to receive
magnetic resonance imaging signals independently of each other and to
transmit received signals through the first and second signal channels,
respectively, to be received by the signal processing system. More
specifically, both loop and dipole antenna are tuned to resonate at the
same Larmour frequency as produced by the magnet.
Applications:
Interventional cardiology
MRI guided surgery
Inventors: Ozgur Kocaturk (NHLBI).
Publications:
1. McKinnon GC, et al. Towards active guidewire visualization in
interventional magnetic resonance imaging. MAGMA. 1996 Mar;4(1):13-18.
2. Ladd ME, et al. Active MR visualization of a vascular guidewire
in vivo. J Magn Reson Imaging. 1998 Jan-Feb;8(1):220-225.
Patent Status: U.S. Provisional Application No. 61/006,265 filed 03
Jan 2008 (HHS Reference No. E-209-2007/0-US-01)
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Institutes of
Health / Cardiac Catheter Core Lab is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize Active two channel 0.035''
guidewire. Please contact Ozgur Kocaturk at 301-402-9430 or
kocaturko@nhlbi.nih.gov.
Respiratory Syncytial Virus (RSV) Vaccines Based on Promoter-Proximate
Attenuation
Description of Technology: Available for licensing and commercial
development is a patent estate and related biological materials for
producing therapeutic or prophylactic vaccines against Respiratory
Syncytial Virus (RSV). The claimed vaccine strategy relates to the
engineering and creation of live-attenuated RSV vaccine candidates by
shifting the position of one or more viral genes relative to the viral
promoter (aka promoter-proximal
[[Page 53436]]
attenuation). The gene shifts can be constructed by insertion, deletion
or rearrangement of genes or genome segments within the recombinant
genome or antigenome. Viral replication can increase or decrease
depending on the position of expressed viral gene and depending on the
nature and degree of the positional shift. Viral gene rearrangements
are selected to maintain sufficient non-infectious replication of RSV
while eliciting host anti-RSV immune responses. Viral genes targeted
for such rearrangement include any of the NS1, NS2, N, P, M, SH,
M2(ORF1), M2(ORF2), L, F or G genes or genome segment.
One modification of particular interest is the placement of the G
and F protective antigen genes in a promoter-proximal position for
increased expression. The gene position-shifted RSV can be further
manipulated by the addition of specific nucleotide and amino acid point
mutations or host range restriction determinants to yield desired
phenotypic and structural effects.
Applications:
Infectious Disease--Respiratory Syncytial Virus
Vaccines
Therapeutics
Prophylactics
Childhood Vaccines
Inventors: Christine D. Krempl, Peter L. Collins, Brian R. Murphy,
Ursula Buchholz, Stephen S. Whitehead (NIAID)
Publications:
1. C Krempl et al. Recombinant respiratory syncytial virus with the
G and F genes shifted to the promoter-proximal positions. J Virol. 2002
Dec;76(23):11931-11942.
2. Y Aloni, N Hay. Attenuation may regulate gene expression in
animal viruses and cells. CRC Crit Rev Biochem. 1985;18(4):327-383.
Patent Status:
HHS Reference No. E-225-2000/0--
U.S. Patent No. 6,923,971 issued 02 Aug 2005
U.S. Patent Application No. 11/033,055 filed 10 Jan 2005
U.S. Patent Application No. 11/054,343 filed 08 Feb 2005
International Patent Application PCT/US2001/20107, which
published as WO 2002/00693 on 03 Jan 2002 (expired)
Australian Patent 2001268709
Brazilian Patent Application PI0112276-2
Canadian Patent Application 2413786
Chinese Patent Application 01814362.8
European Patent Application 01946696.0
Israeli Patent Application 153530
Japanese Patent Application 10-2002-505815
Korean Patent Application 10-2002-7017577 and
Mexican Patent Application 2002-012818.
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The NIAID Office of Technology
Development is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize live attenuated vaccines. Please contact
Michael Piziali at 301-451-3527 for more information.
Quantitative Assessment of Changes in Tissue Status in Disease,
Development, Aging, or Degeneration Using Diffusion Tensor Magnetic
Resonance Imaging
Description of Technology: This invention significantly enhances
the quality and utility of diffusion tensor magnetic resonance imaging
(DT-MRI) data. The patent application for the invention describes
quantitative statistical methodology to extract novel clinical and
biological information from DT-MRI data. These parametric and non-
parametric statistical methods help distinguish changes in tissue state
from background noise inherent in all MRI measurements. The invention
also includes hypothesis tests to determine the statistical
significance of changes observed in MRI ``stains'' (e.g., the Trace of
the diffusion tensor, Trace(D), and the mean apparent diffusion
coefficient, ADC), which are widely used in the diagnosis of stroke.
Further, this invention describes how to detect systematic artifacts in
each pixel of a diffusion weighted image (e.g., artifacts caused by
patient motion). Indeed, this new statistical methodology for analyzing
and interpreting diffusion tensor MRI data should improve the efficacy
of drug screening studies, as well as streamline multi-site and
longitudinal studies designed to assess the safety and efficacy of
drugs undergoing clinical evaluation.
Inventors: Peter J. Basser (NICHD), Sinisa Pajevic (CIT).
Patent Status: U.S. Patent No. 6,845,324 issued 15 Jan 2005 (HHS
Reference No. E-192-1999/0-US-07)
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Human-Bovine Chimeric Respiratory Syncytial Virus (RSV) Vaccines
Description of Technology: Available for licensing and commercial
development is a patent estate and related biological materials for
making human-bovine chimeric virus particles for formulating live
attenuated vaccines against human respiratory syncytial virus (RSV).
Chimeric human-bovine RSVs are recombinantly engineered to incorporate
nucleotide sequences from both human and bovine RSV strains and produce
infectious, chimeric viruses that elicit anti-RSV immunological
responses in humans and non-human primates. The chimeras incorporate
partial or complete human or bovine RSV background genomes with one or
more recombinantly integrated heterologous genes or genome segments of
a different RSV strain.
Heterologous genes of interest for making chimeric recombinants
include NS1, NS2, N, P, M, SH glycoprotein (or an immunogenic domain or
epitope thereof), M2(ORF1), M2(ORF2), L, F or G genes or a genome
segment including a protein or portion thereof or alternatively a
leader, trailer or intergenic region of the RSV genome, or a segment
thereof. A variety of additional mutations and nucleotide modifications
are provided within the human-bovine chimeric RSV of the invention to
yield desired phenotypic and structural effects. Exemplary human-bovine
chimeric RSV of the invention incorporate a chimeric RSV genome or
antigenome comprising both human and bovine polynucleotide sequences,
as well as a major nucleocapsid (N) protein, a nucleocapsid
phosphoprotein (P), a large polymerase protein (L), and an RNA
polymerase elongation factor. Additional RSV proteins may be included
in various combinations to provide a range of infectious subviral
particles up to a complete viral particle or a viral particle
containing supernumerary proteins, antigenic determinants or other
additional components.
Applications:
Infectious Disease--Respiratory Syncytial Virus
Vaccines
Therapeutics
Prophylactics
Childhood Vaccines
Inventors: Ursula Buchholz, Peter L. Collins, Brian R. Murphy,
Stephen S. Whitehead, Christine D. Krempl (NIAID).
[[Page 53437]]
Publications:
1. UJ Buchholz et al. Chimeric bovine respiratory syncytial virus
with glycoprotein gene substitutions from human respiratory syncytial
virus (HRSV): effects on host range and evaluation as a live-attenuated
HRSV vaccine. J Virol. 2000 Feb;74(3):1187-1199.
2. A Karger et al. Recombinant bovine respiratory syncytial virus
with deletions of the G or SH genes: G and F proteins bind heparin. J
Gen Virol. 2001 Mar;82(Pt 3):631-640.
3. UJ Buchholz et al. Generation of bovine respiratory syncytial
virus (BRSV) from cDNA: BRSV NS2 is not essential for virus replication
in tissue culture, and the human RSV leader region acts as a functional
BRSV genome promoter. J Virol. 1999 Jan;73(1):251-259.
Patent Status:
HHS Reference No. E-178-1999/0--
International Patent Application PCT/US00/17755, which
published as WO 2001/04335 on 09 Jan 2001 (expired)
Australian Patent 784216
Chinese Patent 00810119.1
Canadian Patent Application 2378552
European Patent Application 00941756.9
Israeli Patent Application 147447
Japanese Patent Application 2001-509539
Korean Patent Application 10-2002-7000318
Mexican Patent Application 2002-000220
Brazilian Patent Application PI0013195-4 and
Chinese Patent Application 200710167112.6
HHS Reference No. E-178-1999/1--
U.S. Patent Application No. 11/097,946 filed 31 Mar 2005
HHS Reference No. E-178-1999/2--
U.S. Patent Application No. 10/704,116 filed 07 Nov 2003
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The NIAID Office of Technology
Development is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize attenuated live vaccines against respiratory
syncytial virus (RSV). Please contact Barry Buchbinder at 301-594-1696
for more information.
Dated: September 9, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-21519 Filed 9-15-08; 8:45 am]
BILLING CODE 4140-01-P
