Government-Owned Inventions; Availability for Licensing, 17197-17199 [E9-8473]
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Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
Dated: March 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8524 Filed 4–13–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
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.
Insect Salivary Proteins as Potent
Adjuvants for Enhancing Immune
Responses
Description of Technology: This
invention relates to the discovery that
specific sand fly salivary proteins have
marked effects on the outcome of
Leishmania infection. These proteins
have the ability to stimulate strong Th1
and Th2 responses. The Th1 responses
with one protein, PpSP15, result in
immune protection while the Th2
responses to another protein, PpSP44,
exacerbate infection. The protective
protein enhanced a specific immune
response to the infection, suggesting
that it acts as an adjuvant to alter the
environment and presentation of the
parasite antigens.
These immunogenic salivary proteins,
capable of driving Th1 or Th2
responses, can be used as adjuvants in
vaccine development for a broad
spectrum of diseases that require
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different immune responses. They may
therefore be used to enhance immune
responses to pathogens other than
Leishmania parasites. They are also very
potent in their effect, and small doses
are sufficient to elicit a strong immune
response. This potency can reduce the
need to use chemical adjuvants, which
often require large mounts of material
and can have deleterious side effects.
Applications:
• Vaccine for Leishmania parasite
and other pathogenic infections.
• Potent adjuvant for a broad
spectrum of diseases.
Advantages: Efficient, potent, and less
toxic than many chemical adjuvants.
Development Status: Early Stage.
Market:
• 88 countries with an estimated 2
million people affected each year.
• Estimated 350 million at risk
worldwide.
Inventors: Jesus G. Valenzuela et al.
(NIAID).
Publication: F Oliveira, PG Lawyer, S
Kamhawi, JG Valenzuela. Immunity to
distinct sand fly salivary proteins
primes the anti-Leishmania immune
response towards protection or
exacerbation of disease. PLoS Negl Trop
Dis. 2008 Apr 16;2(4):e226.
Patent Status: U.S. Provisional
Application No. 61/089,884 filed 08
Aug 2008 (HHS Reference No. E–303–
2008/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jeffrey A. James
PhD; 301–435–5474;
jeffreyja@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 the Insect Salivary
Proteins as potent immune response
adjuvants. Please contact Charles
Rainwater at crainwater@niaid.nih.gov
or 301/496–2644 for more information.
Anti-Cancer Oligodeoxynucleotides
Description of Technology: A majority
of human cancers originate from
epithelial tissue. A common cancer of
epithelial cell origin is non-melanoma
skin cancer (NMSC), including basal
cell carcinoma (BCC) and squamous cell
carcinoma (SCC), with more than seven
hundred thousand (700,000) new cases
diagnosed each year in the United States
alone. BCC is rarely life-threatening
because it is slow growing and is mostly
localized. Unlike BCC, SCC metastasizes
at a rate of two (2) to six (6) percent over
several years after the initial diagnosis.
A highly malignant form invades and
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17197
destroys tissue, and then metastasizes,
initially to a regional lymph node before
more distant organs such as the lungs or
brain are affected. SCC is commonly
encountered in a number of epithelial
tissues, including the oral cavity,
esophagus, larynx, bronchi, intestines,
colon, genital tract, and skin.
This application relates to
suppressive CpG oligodeoxynucleotides
(ODNs). This application claims
suppressive ODN compositions and
their use to prevent or delay the
formation of a tumor, reducing the risk
of developing a tumor, treating a tumor,
preventing conversion of a benign to a
malignant lesion, or preventing
metastasis. Topical application of the
ODNs of this invention in preclinical
studies resulted in significantly fewer
animals developing papillomas and
fewer papillomas/animal. The invention
also relates to use of suppressive ODNs
to prevent/delay cancer when
administered systemically as well as
locally.
Application: Development of anticancer vaccines, therapeutics and
diagnostics.
Development Status: ODNs have been
synthesized and preclinical studies have
been performed.
Inventors: Dennis M. Klinman and
Hidekazu Ikeuchi (NCI)
Patent Status: U.S. Provisional
Application No. 61/119,998 filed 04 Dec
2008 (HHS Reference No. E–296–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Experimental
Immunology, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact John D. Hewes, PhD at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Neutralization of Hepatitis C Virus
(HCV)
Description of Technology: Available
for licensing and commercial
development are compositions and
methods for preventing and/or treating
infection caused by hepatitis C virus
(HCV). The invention is based on
mapping studies conducted by the
inventors of two epitopes within HCV
E2: epitope I and epitope II. It has been
discovered that epitope I is involved in
virus neutralization but that epitope II
mediates antibody interference,
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14APN1
17198
Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
probably an adaptation of the virus to
obfuscate the immune system. In an
effort to attenuate or disable the
interference effect of HCV–E2 epitope II,
the present invention is directed to a
HCV E2 polypeptide substitution/
deletion of native amino acids LFY in
epitope II, a HCV E2 polypeptide
insertion of amino acids between the
native LFY in epitope II, or the use of
epitope II as a molecular decoyant or to
affinity-purify an immune globulin to
deplete interfering antibodies from, and
enrich neutralizing antibodies in, the
preparation.
Applications: HCV vaccines; HCV
therapeutics.
Advantages: Improved HCV vaccines
and therapeutics.
Development Status: The technology
is currently in the preclinical stage of
development.
Inventors: Pei Zhang, Marian Major,
Stephen Feinstone (FDA).
Publications:
1. P Zhang et al. Hepatitis C virus
epitope-specific neutralizing antibodies
in Igs prepared from human plasma.
Proc Natl Acad Sci USA. 2007 May
15;104(20):8449–8454.
2. MY Yu et al. Neutralizing
antibodies to hepatitis C virus (HCV) in
immune globulins derived from antiHCV-positive plasma. Proc Natl Acad
Sci USA. 2004 May 18;101(20):7705–
7710.
Patent Status:
U.S. Provisional Application No. 61/
002,031 filed 06 Nov 2007 (HHS
Reference No. E–276–2007/0–US–01).
PCT Application No. PCT/US2008/
082368 filed 04 Nov 2008 (HHS
Reference No. E–276–2007/1–PCT–01).
Licensing Status: Available for
licensing.
Licensing Contact: RC Tang, JD, LLM;
301–435–5031; tangrc@mail.nih.gov.
Collaborative Research Opportunity:
The FDA Center for Biologics
Evaluation and Research, Laboratory of
Plasma Derivatives, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact Alice Welch, PhD at 301–827–
0359 or Alice.Welch@fda.hhs.gov for
more information.
Live-Attenuated West Nile Virus
Vaccines with Improved Immune
Responses
Description of Technology: West Nile
virus (WNV), the etiologic agent of West
Nile virus fever and encephalitis, is an
emerging human and veterinary
pathogen in North America. WNV also
periodically poses a serious threat to
public health in Africa, Australia,
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Europe, the Middle East, and Asia.
There is no vaccine available. WNV
strains are phylogenetically grouped
into two distinct lineages based
primarily on differences within the
envelope (Env) protein gene segment.
The highly virulent strains recently
emergent on the North American
continent are of lineage I. Lineage I
viruses are primarily also isolated in the
Middle East, Europe, and parts of
Africa. Lineage II viruses are mostly
isolated in Africa. Both lineages include
highly neurovirulent as well as
relatively attenuated strains of WNV.
WN vaccine viruses developed by
others are chimeric live attenuated WN
vaccine viruses. The genomes of these
viruses encode the C and NS proteins of
dengue or yellow fever virus,
respectively, along with the WNV prM
and Env proteins, which are the major
targets of the humoral immune response
to flaviviruses. These chimeric live
attenuated WN vaccines have been
successful in animal testing and some
are currently in clinical trials. However,
these vaccines have two potential
disadvantages due to their
heterogeneous genetic composition: (i)
Animal host range may be different from
that of wild-type WNV, rendering the
vaccines less than optimal for
immunization of some at-risk species
and (ii) the elicited immune response
may be suboptimal in duration or
quality, due to the absence from these
vaccines of homologous WN NS
proteins.
FDA’s technology that is available for
licensing comprises live attenuated
West Nile viruses that are not chimeric,
but instead have one or more mutations
in the 3′ terminal stem loop secondary
structure, resulting in decreased
neurovirulence. The related patent
application also claims methods of
making the viruses claimed in the
application and methods for using these
viruses to prevent or treat WN infection.
More specifically, the inventors
modified infectious WN DNA such that
all or segments of the wild-type WN 3′
stem loop nucleotide sequence was
replaced with analogous dengue virus
serotype 2 3′ stem loop sequences. The
inventors also created a number of point
mutations in the nucleotide sequence of
the WN 3′ stem loop sequence.
Application: Development of live
attenuated West Nile Virus vaccines,
therapeutics and diagnostics.
Development Status: Vaccine
candidates have been prepared and
preclinical (mouse) studies have been
performed.
Inventors: Lewis Markoff and Li Yu
(FDA/CBER).
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Publication: L Yu et al. Attenuated
West Nile viruses bearing 3′SL and
envelope gene substitution mutations.
Vaccine. 2008 Nov 5;26(47):5981–5988.
Patent Status:
HHS Reference No. E–022–2004/0—
• U.S. Provisional Patent Application
No. 60/579,396 filed 14 Jun 2004.
• PCT Patent Application No. PCT/
US2005/0207327 filed 14 Jun 2005.
• U.S. Patent Application No. 11/
629,560 filed 14 Dec 2006.
Licensing Status: Available for
licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The FDA Office of Vaccines Research &
Review is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize West Nile Virus
vaccines. Please contact Alice Y. Welch,
PhD, at 301–827–0359 or
Alice.Welch@fda.hhs.gov for more
information.
Neuronal Decoding Algorithm for
Prosthetic Limbs
Description of Technology: The
invention is a new algorithm for
decoding neuronal responses based on
the discovery that neuronal spike trains
can be described using order statistics.
The device has applications in the
direct control of prosthetic limbs by
neuronal signals originating from
electrodes placed in the brain. The
method allows for decoding neuronal
responses by monitoring sequences of
potentials from neurons while specific
motor tasks are carried out. The
sequences are then characterized using
the innovative technique of applying
order statistics to the spike train, such
that subsequent action potentials
representing unidentified motor tasks
can be decoded to determine the
unknown task. The invention is of
substantial importance because it
appears to have achieved a closed form
interpretation of neuronal responses
upon which a motor prosthetic device
might be based.
Applications: Direct control of
prosthetic limbs by neurons; Closed
form interpretation of neuronal response
for prosthetic devices.
Development Status: Early Stage.
Inventors: Barry J. Richmond and
Matthew C. Wiener (NIMH).
Patent Status: U.S. Patent No.
7,442,212 issued 28 Oct 2008 (HHS
Reference No. E–038–2001/0–US–03).
Licensing Status: Available for
licensing.
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14APN1
Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
Licensing Contact: Jeffrey A. James,
PhD; 301–435–5474;
jeffreyja@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Mental Health,
Laboratory of Neuropsychology, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
decoding algorithm for neuronal
responses. Please contact Suzanne
Winfield at winfiels@mail.nih.gov or
301–402–4324 for more information.
Dated: April 7, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–8473 Filed 4–13–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing: Methods for
Improvements and Enhancements of
Diffusion Tensor MRI
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 contacting either
Uri Reichman, PhD, MBA (Phone: 301–
435–4616; Fax: 301–402–0220; E-mail:
UR7a@nih.gov) or John Stansberry, PhD
(Phone: 301–435–5236; Fax: 301–402–
0220; E-mail: stansbej@mail.nih.gov) at
the Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, Maryland 20852–3804. A
signed Confidential Disclosure
Agreement will be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: The
technology offered for licensing is in the
field of Diffusion Magnetic Resonance
Imaging (MRI). Specifically, three new
SUMMARY:
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methods have been described and
claimed that enhance the scope and
applicability of Diffusion Tensor MRI
(DTI or DT–MRI).
The invention of DTI represented a
breakthrough in MRI. It provides a
method and system for measuring the
effective diffusion tensor of spin-labeled
molecules, and for generating images of
key tensor-derived parameters that
indicate features of tissue
microstructure, organization and even
physiological state. DTI data has
improved the diagnosis of a large
number of diseases, disorders, and
conditions, and is also being used
therapeutically, for instance, to aid
neurosurgical planning.
One of the pioneers in Diffusion MRI,
Dr. Peter Basser, a Principal Investigator
in NIH’s Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), is the
primary inventor of DTI. Dr. Basser’s
first contribution in this field is
described in US Patent #5,539,310
(issued July 23, 1996), entitled ‘‘Method
and System for Measuring the Diffusion
Tensor and for Diffusion Tensor
Imaging.’’ His new inventions
(described below) extend the specificity
and clinical value of diffusion MRI data,
particularly in elucidating fine
microstructural details and features that
are not detectable using DTI.
Diffusion Tensor and q-Space MRI
Specimen Characterization
Description of Technology
Diffusion Tensor MRI (DTI or DT–
MRI) provides information primarily
about how water diffuses in the
extracellular compartment of tissues,
where water mobility is hindered (i.e.,
where water diffuses freely but
encounters barriers from which it is
reflected). However, DTI does not
provide a complete characterization of
diffusion in the intracellular
compartment of some cells, particularly
myelinated axons, where water mobility
is restricted by impermeable membranes
(i.e., where water is trapped but
otherwise free to diffuse within the
cell).
The subject invention provides a new
modeling framework that selfconsistently describes 3–D anisotropic
diffusion within a hindered
extracellular compartment and within a
restricted intra-axonal compartment. It
results in an improved characterization
and measurement tissue and cell
microstructure in neuronal tissue,
which promises to advance diagnosis of
neurological conditions (e.g., Stroke,
MS, Alzheimer’s disease), possibly
cognitive and behavioral disorders (e.g.,
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17199
schizophrenia), as well as our ability to
follow normal development and aging
processes.
More specifically, this new in vivo
diffusion MRI method, especially suited
for the characterization of brain white
matter, marries q-space and DTI
concepts: Diffusion within axons is
modeled as hindered diffusion parallel
to the axis of the axon, and restricted
diffusion perpendicular to the axis.
Diffusion exterior to axons is modeled
as hindered diffusion with differing
diffusivities parallel and perpendicular
to the nerves’ axis. To practice this
method, diffusion weighted (DW) MRI
data are acquired from specimens at
different q-values (with different
diffusion gradient magnitudes and
directions). Parameters associated with
tissue microstructure, such as the intra
and extra-axonal principal diffusivities
and their corresponding principal
directions, and the volume fractions of
intra and extra-axonal space are then
estimated from these data. Improved
angular resolution of fiber tract
orientation can be obtained for
tractography studies and more
microstructural information can be
gleaned for both diagnostic and
therapeutic purposes than from
conventional DTI. This technology has
been named CHARMED (Composite
Hindered and Restricted Model of
Diffusion).
Inventors
Peter J. Basser (NICHD) et al.
Publications
1. Y Assaf, RZ Freidlin, GK Rohde, PJ
Basser. New modeling and experimental
framework to characterize hindered and
restricted water diffusion in brain white
matter. Magn Reson Med. 2004
Nov;52(5):965–978.
2. Y Assaf and PJ Basser. Composite
hindered and restricted model of
diffusion (CHARMED) MR imaging of
the human brain. Neuroimage 2005 Aug
1;27(1):48–58.
¨
3. L Avram, E Ozarslan, Y Assaf, A
Bar-Shir, Y Cohen, PJ Basser. Threedimensional water diffusion in
impermeable cylindrical tubes: theory
versus experiments. NMR Biomed. 2008
Oct;21(8):888–898.
4. A Bar-Shir, L Avram, Y Assaf, PJ
Basser, Y Cohen. Experimental
Parameters and Diffraction Patterns at
High q Diffusion MR: Experiments and
Theoretical Simulations. Proc Intl Soc
Mag Reson Med. 2007;15:1530.
Patent Status
U.S. Patent Application No. 10/
888,917 filed 08 Jul 2004, claiming
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14APN1
Agencies
[Federal Register Volume 74, Number 70 (Tuesday, April 14, 2009)]
[Notices]
[Pages 17197-17199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of Federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
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.
Insect Salivary Proteins as Potent Adjuvants for Enhancing Immune
Responses
Description of Technology: This invention relates to the discovery
that specific sand fly salivary proteins have marked effects on the
outcome of Leishmania infection. These proteins have the ability to
stimulate strong Th1 and Th2 responses. The Th1 responses with one
protein, PpSP15, result in immune protection while the Th2 responses to
another protein, PpSP44, exacerbate infection. The protective protein
enhanced a specific immune response to the infection, suggesting that
it acts as an adjuvant to alter the environment and presentation of the
parasite antigens.
These immunogenic salivary proteins, capable of driving Th1 or Th2
responses, can be used as adjuvants in vaccine development for a broad
spectrum of diseases that require different immune responses. They may
therefore be used to enhance immune responses to pathogens other than
Leishmania parasites. They are also very potent in their effect, and
small doses are sufficient to elicit a strong immune response. This
potency can reduce the need to use chemical adjuvants, which often
require large mounts of material and can have deleterious side effects.
Applications:
Vaccine for Leishmania parasite and other pathogenic
infections.
Potent adjuvant for a broad spectrum of diseases.
Advantages: Efficient, potent, and less toxic than many chemical
adjuvants.
Development Status: Early Stage.
Market:
88 countries with an estimated 2 million people affected
each year.
Estimated 350 million at risk worldwide.
Inventors: Jesus G. Valenzuela et al. (NIAID).
Publication: F Oliveira, PG Lawyer, S Kamhawi, JG Valenzuela.
Immunity to distinct sand fly salivary proteins primes the anti-
Leishmania immune response towards protection or exacerbation of
disease. PLoS Negl Trop Dis. 2008 Apr 16;2(4):e226.
Patent Status: U.S. Provisional Application No. 61/089,884 filed 08
Aug 2008 (HHS Reference No. E-303-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jeffrey A. James PhD; 301-435-5474;
jeffreyja@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 the Insect Salivary Proteins as potent
immune response adjuvants. Please contact Charles Rainwater at
crainwater@niaid.nih.gov or 301/496-2644 for more information.
Anti-Cancer Oligodeoxynucleotides
Description of Technology: A majority of human cancers originate
from epithelial tissue. A common cancer of epithelial cell origin is
non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC)
and squamous cell carcinoma (SCC), with more than seven hundred
thousand (700,000) new cases diagnosed each year in the United States
alone. BCC is rarely life-threatening because it is slow growing and is
mostly localized. Unlike BCC, SCC metastasizes at a rate of two (2) to
six (6) percent over several years after the initial diagnosis. A
highly malignant form invades and destroys tissue, and then
metastasizes, initially to a regional lymph node before more distant
organs such as the lungs or brain are affected. SCC is commonly
encountered in a number of epithelial tissues, including the oral
cavity, esophagus, larynx, bronchi, intestines, colon, genital tract,
and skin.
This application relates to suppressive CpG oligodeoxynucleotides
(ODNs). This application claims suppressive ODN compositions and their
use to prevent or delay the formation of a tumor, reducing the risk of
developing a tumor, treating a tumor, preventing conversion of a benign
to a malignant lesion, or preventing metastasis. Topical application of
the ODNs of this invention in preclinical studies resulted in
significantly fewer animals developing papillomas and fewer papillomas/
animal. The invention also relates to use of suppressive ODNs to
prevent/delay cancer when administered systemically as well as locally.
Application: Development of anti-cancer vaccines, therapeutics and
diagnostics.
Development Status: ODNs have been synthesized and preclinical
studies have been performed.
Inventors: Dennis M. Klinman and Hidekazu Ikeuchi (NCI)
Patent Status: U.S. Provisional Application No. 61/119,998 filed 04
Dec 2008 (HHS Reference No. E-296-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Experimental Immunology, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact John D. Hewes, PhD at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Neutralization of Hepatitis C Virus (HCV)
Description of Technology: Available for licensing and commercial
development are compositions and methods for preventing and/or treating
infection caused by hepatitis C virus (HCV). The invention is based on
mapping studies conducted by the inventors of two epitopes within HCV
E2: epitope I and epitope II. It has been discovered that epitope I is
involved in virus neutralization but that epitope II mediates antibody
interference,
[[Page 17198]]
probably an adaptation of the virus to obfuscate the immune system. In
an effort to attenuate or disable the interference effect of HCV-E2
epitope II, the present invention is directed to a HCV E2 polypeptide
substitution/deletion of native amino acids LFY in epitope II, a HCV E2
polypeptide insertion of amino acids between the native LFY in epitope
II, or the use of epitope II as a molecular decoyant or to affinity-
purify an immune globulin to deplete interfering antibodies from, and
enrich neutralizing antibodies in, the preparation.
Applications: HCV vaccines; HCV therapeutics.
Advantages: Improved HCV vaccines and therapeutics.
Development Status: The technology is currently in the preclinical
stage of development.
Inventors: Pei Zhang, Marian Major, Stephen Feinstone (FDA).
Publications:
1. P Zhang et al. Hepatitis C virus epitope-specific neutralizing
antibodies in Igs prepared from human plasma. Proc Natl Acad Sci USA.
2007 May 15;104(20):8449-8454.
2. MY Yu et al. Neutralizing antibodies to hepatitis C virus (HCV)
in immune globulins derived from anti-HCV-positive plasma. Proc Natl
Acad Sci USA. 2004 May 18;101(20):7705-7710.
Patent Status:
U.S. Provisional Application No. 61/002,031 filed 06 Nov 2007 (HHS
Reference No. E-276-2007/0-US-01).
PCT Application No. PCT/US2008/082368 filed 04 Nov 2008 (HHS
Reference No. E-276-2007/1-PCT-01).
Licensing Status: Available for licensing.
Licensing Contact: RC Tang, JD, LLM; 301-435-5031;
tangrc@mail.nih.gov.
Collaborative Research Opportunity: The FDA Center for Biologics
Evaluation and Research, Laboratory of Plasma Derivatives, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
this technology. Please contact Alice Welch, PhD at 301-827-0359 or
Alice.Welch@fda.hhs.gov for more information.
Live-Attenuated West Nile Virus Vaccines with Improved Immune Responses
Description of Technology: West Nile virus (WNV), the etiologic
agent of West Nile virus fever and encephalitis, is an emerging human
and veterinary pathogen in North America. WNV also periodically poses a
serious threat to public health in Africa, Australia, Europe, the
Middle East, and Asia. There is no vaccine available. WNV strains are
phylogenetically grouped into two distinct lineages based primarily on
differences within the envelope (Env) protein gene segment. The highly
virulent strains recently emergent on the North American continent are
of lineage I. Lineage I viruses are primarily also isolated in the
Middle East, Europe, and parts of Africa. Lineage II viruses are mostly
isolated in Africa. Both lineages include highly neurovirulent as well
as relatively attenuated strains of WNV.
WN vaccine viruses developed by others are chimeric live attenuated
WN vaccine viruses. The genomes of these viruses encode the C and NS
proteins of dengue or yellow fever virus, respectively, along with the
WNV prM and Env proteins, which are the major targets of the humoral
immune response to flaviviruses. These chimeric live attenuated WN
vaccines have been successful in animal testing and some are currently
in clinical trials. However, these vaccines have two potential
disadvantages due to their heterogeneous genetic composition: (i)
Animal host range may be different from that of wild-type WNV,
rendering the vaccines less than optimal for immunization of some at-
risk species and (ii) the elicited immune response may be suboptimal in
duration or quality, due to the absence from these vaccines of
homologous WN NS proteins.
FDA's technology that is available for licensing comprises live
attenuated West Nile viruses that are not chimeric, but instead have
one or more mutations in the 3' terminal stem loop secondary structure,
resulting in decreased neurovirulence. The related patent application
also claims methods of making the viruses claimed in the application
and methods for using these viruses to prevent or treat WN infection.
More specifically, the inventors modified infectious WN DNA such that
all or segments of the wild-type WN 3' stem loop nucleotide sequence
was replaced with analogous dengue virus serotype 2 3' stem loop
sequences. The inventors also created a number of point mutations in
the nucleotide sequence of the WN 3' stem loop sequence.
Application: Development of live attenuated West Nile Virus
vaccines, therapeutics and diagnostics.
Development Status: Vaccine candidates have been prepared and
preclinical (mouse) studies have been performed.
Inventors: Lewis Markoff and Li Yu (FDA/CBER).
Publication: L Yu et al. Attenuated West Nile viruses bearing 3'SL
and envelope gene substitution mutations. Vaccine. 2008 Nov
5;26(47):5981-5988.
Patent Status:
HHS Reference No. E-022-2004/0--
U.S. Provisional Patent Application No. 60/579,396 filed
14 Jun 2004.
PCT Patent Application No. PCT/US2005/0207327 filed 14 Jun
2005.
U.S. Patent Application No. 11/629,560 filed 14 Dec 2006.
Licensing Status: Available for licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The FDA Office of Vaccines
Research & Review is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize West Nile Virus vaccines. Please contact
Alice Y. Welch, PhD, at 301-827-0359 or Alice.Welch@fda.hhs.gov for
more information.
Neuronal Decoding Algorithm for Prosthetic Limbs
Description of Technology: The invention is a new algorithm for
decoding neuronal responses based on the discovery that neuronal spike
trains can be described using order statistics. The device has
applications in the direct control of prosthetic limbs by neuronal
signals originating from electrodes placed in the brain. The method
allows for decoding neuronal responses by monitoring sequences of
potentials from neurons while specific motor tasks are carried out. The
sequences are then characterized using the innovative technique of
applying order statistics to the spike train, such that subsequent
action potentials representing unidentified motor tasks can be decoded
to determine the unknown task. The invention is of substantial
importance because it appears to have achieved a closed form
interpretation of neuronal responses upon which a motor prosthetic
device might be based.
Applications: Direct control of prosthetic limbs by neurons; Closed
form interpretation of neuronal response for prosthetic devices.
Development Status: Early Stage.
Inventors: Barry J. Richmond and Matthew C. Wiener (NIMH).
Patent Status: U.S. Patent No. 7,442,212 issued 28 Oct 2008 (HHS
Reference No. E-038-2001/0-US-03).
Licensing Status: Available for licensing.
[[Page 17199]]
Licensing Contact: Jeffrey A. James, PhD; 301-435-5474;
jeffreyja@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Mental Health, Laboratory of Neuropsychology, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize decoding
algorithm for neuronal responses. Please contact Suzanne Winfield at
winfiels@mail.nih.gov or 301-402-4324 for more information.
Dated: April 7, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-8473 Filed 4-13-09; 8:45 am]
BILLING CODE 4140-01-P