Government-Owned Inventions; Availability for Licensing, 63167-63169 [E8-25221]
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sonnei. Specifically, an attenuated
bacteria capable of expressing an S.
sonnei antigen comprised of the S.
sonnei form I O-polysaccharide
expressed from the S. sonnei rfb/rfc
gene cluster is claimed. The inventors
have shown that the claimed vaccine
compositions showed one hundred
percent (100%) protection against
parenteral challenge with virulent S.
sonnei in mice.
Inventors: Dennis J. Kopecko (FDA),
De-Qi Xu (NIDCR), John O. Cisar
(NIDCR).
Patent Status: U.S. Patent Application
No. 10/346,706 filed 15 Jan 2003,
claiming priority to 16 Jan 2002 (HHS
Reference No. E–210–2001/0–US–02)
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
085–2005/0–PCT–02); U.S. Patent
Application filed 15 Sep 2008 (HHS
Reference No. E–085–2005/0–US–03).
Licensing Status: Available for
exclusive or non-exclusive licensing.
The technology is not available for
licensing in the field of use of
multivalent meningitis vaccines.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
A Method With Increased Yield for
Production of Polysaccharide-Protein
Conjugate Vaccines Using Hydrazide
Chemistry
Description of Technology: Current
methods for synthesis and
manufacturing of polysaccharideprotein conjugate vaccines employ
conjugation reactions with low
efficiency (about twenty percent). This
Methods for Preparing Complex
means that up to eighty percent of the
Multivalent Immunogenic Conjugates
added activated polysaccharide (PS) is
Description of Technology: Claimed in lost. In addition, inclusion of a
this application are novel methods for
chromatographic process for
preparing complex multivalent
purification of the conjugates from
immunogenic conjugates and conjugate
unconjugated PS is required.
vaccines. The multivalent conjugates
The present invention utilizes the
and conjugate vaccines are synthesized
characteristic chemical property of
by conjugating mixtures of more than
hydrazide groups on one reactant to
one polysaccharide at a desired ratio of
react with aldehyde groups or cyanate
the component polysaccharides to at
esters on the other reactant with an
least one carrier protein using hydrazide improved conjugate yield of at least
chemistry. Because of the high
sixty percent. With this conjugation
efficiency of hydrazide chemistry in
efficiency the leftover unconjugated
conjugation, the polysaccharides are
protein and polysaccharide would not
effectively conjugated to the carrier
need to be removed and thus the
protein(s) so that the resulting complex
purification process of the conjugate
synthesized vaccine conjugate products, product can be limited to diafiltration to
without requiring tedious and
remove the by-products of small
complicated purification procedures
molecules. The new conjugation
such as chromatography and/or
reaction can be carried out within one
ammonium sulfate precipitation, are
or two days with reactant
efficacious in inducing antibodies in
concentrations between 1 and 25 mg/mL
mice against each component
at PS/protein ratios from 1:2 to 3:1, at
polysaccharide. The methods claimed in temperatures between 4 and 40 degrees
this application simplify the preparation Centigrade, and in a pH range of 5.5 to
of multivalent conjugate vaccines by
7.4, optimal conditions varying from PS
utilizing simultaneous conjugation
to PS.
reactions in a single reaction mixture or
Application: Cost effective and
batch that includes at least two
efficient manufacturing of conjugate
immunogenic-distinct polysaccharides.
vaccines.
Inventors: Che-Hung Robert Lee and
This single-batch simultaneous reaction
eliminates the need for multiple parallel Carl E. Frasch (CBER/FDA).
Patent Status: U.S. Patent Application
synthesis processes for each
No. 10/566,899 filed 01 Feb 2006,
polysaccharide vaccine conjugate
claiming priority to 06 Aug 2003 (HHS
component as employed in
Reference No. E–301–2003/0–US–10);
conventional methods for making
U.S. Patent Application No. 10/566,898
multivalent conjugate vaccines.
filed 01 Feb 2006, claiming priority to
Application: Cost effective and
06 Aug 2003 (HHS Reference No. E–
efficient manufacturing of conjugate
301–2003/1–US–02); International
vaccines.
Inventors: Che-Hung Robert Lee
rights available.
Licensing Status: Available for non(CBER/FDA).
Patent Status: PCT Application No.
exclusive licensing.
Licensing Contact: Peter A. Soukas,
PCT/US2007/006627 filed 16 Mar 2007,
J.D.; 301–435–4646;
which published as WO 2007/109129
soukasp@mail.nih.gov.
on 27 Sep 2007 (HHS Reference No. E–
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63167
Dated: October 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–25220 Filed 10–22–08; 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
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.
Gene Expression Profiling for Prognosis
of a Non-Hodgkin Lymphoma
Description of Technology: Diffuse
large B cell lymphoma (DLBCL) is a
quickly progressing cancer of the white
blood cells, which is the most common
type of non-Hodgkin lymphoma. Most
commonly, DLBCL is treated
aggressively with combination
chemotherapy referred to as R–CHOP.
Fortunately, with this treatment more
than half of these patients can be cured
or show remission. However, other
patients do not respond to treatment
and succumb to the disease. Therefore,
it would be helpful to predict which
patients are likely not to respond to R–
CHOP and would benefit from alternate
treatments.
This invention provides gene
microarrays and method of use claims
for a survival predictor calculated for
DLBCL patients undergoing
combination therapy. By measuring the
E:\FR\FM\23OCN1.SGM
23OCN1
63168
Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
gene expression of genes from cancer
biopsies it is possible to identify
patients that are unlikely to be cured by
R–CHOP and could benefit from
alternative treatments like antiangiogenic drugs.
Applications: Diagnostic test for
managing treatment of DLBCL patients;
Design and analysis of clinical trials in
DLBCL.
Market: About 16,000 new cases per
year of DLBCL in U.S.; Affects mostly
the middle-aged but it can afflict
children.
Development Status: Clinical data is
available.
Inventors: Louis M. Staudt (NCI).
Publication: A Rosenwald et al. The
use of molecular profiling to predict
survival after chemotherapy for diffuse
large-B-cell lymphoma. N Engl J Med.
2002 Jun 20;346(25):1937–1947.
Patent Status: U.S. Provisional
Application No. 61/059,678 filed 06 Jun
2008 (HHS Reference No. E–256–2008/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Sabarni Chatterjee,
PhD; 301–435–5587;
stansbej@mail.nih.gov.
dwashington3 on PRODPC61 with NOTICES
A Simple Genetic Test for Kidney
Disease
Description of Technology: This
technology relates to methods of
diagnosing a predisposition to diseases
that cause chronic kidney disease (CKD)
and end-stage kidney disease (ESKD).
Variations in a gene, non-muscle
myosin IIA (MYH9), are associated with
79% of the risk of focal segmental
glomerulosclerosis (FSGS), the disease
that causes ESKD, in African Americans
with HIV, and 56% of African
Americans as a whole. The variants are
also associated with a 2–3 fold
increased risk for end-stage kidney
disease (ESKD) associated with
hypertension. The variations are also
present among European Americans,
however they are less common.
A simple genetic screening test has
been developed that identifies single
nucleotide polymorphisms (SNP) and
haplotypes in the non-muscle myosin
gene MYH9. These variants confer
genetic risk for the following kidney
diseases: FSGS, collapsing
glomerulopathy, HIV-associated
nephropathy, hypertensive kidney
disease, sickle cell nephropathy, lupus
nephropathy, and possibly other kidney
diseases.
Applications:
• Facilitate rigorous population (i.e.
all individuals) screening for early
kidney disease.
VerDate Aug<31>2005
14:58 Oct 22, 2008
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• Screen individuals with
hypertension, to identify individuals
who might benefit from more intensive
therapy.
• Screen kidney donors for MYH9
risk alleles to improve renal allograft
survival.
• Screen patients with sickle cell
disease to identify those at increased
risk for CKD.
• Screen patients with lupus
nephritis to identify those at increased
risk for CKD.
• Screen patients with HIV–1
infection to identify those at increased
risk for kidney disease.
• Screen patient with other kidney
diseases, including idiopathic and
secondary kidney disease, where MYH9
mutations may alter the propensity to
develop kidney disease or the rate of
progressive renal function decline.
• Pharmaceutical agents might be
developed that reverse the susceptibility
phenotype, reducing propensity to CKD.
These agents might alter non-muscle
myosin IIA function or its interactions
with critical molecular partners.
Market: An estimated 26 millions
have CKD, with impaired glomerular
filtration rate and approximately
100,000 individuals in the United States
develop ESKD every year. The lifetime
risk for ESKD is 7.5% of individuals of
African American descent and 2.1% for
individuals of European descent. Early
identification of individuals with MYH9
variants who are at increased risk for
CKD might substantially reduce
morbidity and mortality in this
population, as impaired kidney function
is associated with death from
cardiovascular disease even in patients
who do not progress to ESKD.
Development Status: Early-stage
development for clinical applications,
including diagnostic testing and
therapeutic intervention.
Inventors: Cheryl A. Winkler (SAIC/
NCI), George W. Nelson (SAIC/NCI),
Jeffrey B. Kopp (NIDDK), Michael W.
Smith (SAIC/NCI), Randall C. Johnson
(SAIC/NCI).
Publication: JB Kopp et al. MYH9 is
a major-effect risk gene for focal
segmental glomerulosclerosis. Nat
Genet. 2008 Oct;40(10):1175–1184.
Patent Status: U.S. Provisional
Application No. 61/024,863 filed 30 Jan
2008 (HHS Reference No. E–090–2008/
0–US–01); U.S. Provisional Application
No. 61/095,590 filed 09 Sep 2008 (HHS
Reference No. E–090–2008/1–US–01).
Licensing Status: Available for nonexclusive and exclusive licensing.
Licensing Contact: Steve Standley,
PhD; 301–435–4074;
sstand@mail.nih.gov.
PO 00000
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Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Genomic Diversity, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
genetic testing for MYH9. Please contact
John D. Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Nanoparticles for Imaging and
Treatment of Brain Tumors
Description of Technology: Malignant
brain tumors, whether arising within the
brain or invading the brain from other
tissues, are difficult to treat.
Conventional chemotherapy drugs do
not reach therapeutic levels in brain
tumor tissue, and do not remain in brain
tumor tissue for long enough to enter
brain tumor cells and kill them. As a
consequence, these chemotherapy drugs
are not effective at treating malignant
brain tumors growing in patients, even
though these drugs are effective at
killing brain tumor cells growing in
culture.
This invention claims that
intravenously administered
functionalized polyamidoamine
(PAMAM) dendrimers of certain sizes
can selectively cross the blood-brain
barrier (BBB) of malignant brain tumors,
and can accumulate over time within
individual brain tumor cells.
Gadolinium and fluorescent probe
conjugated dendrimers with these
properties can be used for simultaneous
magnetic resonance and fluorescence
imaging of brain tumor cells. Since
these nanoparticles possess numerous
additional surface functional groups, in
addition to being useful for multimodality imaging, functionalized
dendrimers can also be useful for the
simultaneous delivery of cytotoxic
drugs and inhibitors of tumor cell
metabolic or migratory pathways.
Advantages:
• Intravenously administered
nanoparticles selectively cross the BBB
of brain tumors and accumulate within
brain tumor cells but not normal brain
cells.
• Nanoparticles accumulate in and
are retained in brain tumor tissue for
long enough to result in the effective
uptake of nanoparticles by individual
brain tumor cells.
• Nanoparticle size can be adjusted to
achieve the desired particle blood halflife.
• A wide variety of agents can be
attached to the functional groups on the
nanoparticle exterior.
Applications:
E:\FR\FM\23OCN1.SGM
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Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
dwashington3 on PRODPC61 with NOTICES
• Anatomic and metabolic imaging of
brain and spinal cord tumors for
diagnostic and therapeutic purposes.
• Intravenous treatment of brain and
spinal cord tumors.
• Imaging of intravenous drug
delivery to brain and spinal cord
tumors.
• Potential to be used for imaging and
treatment of other neurological
disorders in which the BBB becomes
porous.
Market: In 2008, it is estimated that
malignant tumors of the brain and
spinal cord will account for about 1.5%
of all cancers and 2.3% of all expected
cancer-related deaths.
Development Status: Early stage
development; Pre-clinical data
available.
Inventor: Hemant Sarin (CC).
Patent Status: U.S. Provisional
Application No. 61/055,328 filed 22
May 2008 (HHS Reference No. E–063–
2008/0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
Induced Internalization of Surface
Receptors
Description of Technology: Cellsurface receptors are responsible for the
biological activities of many molecules.
Specific ligands bind to them, causing
the cell-surface receptors to internalize
or bring the receptor and ligand inside
the cell. A number of diseases,
including cancer, metabolic disorders,
and viral infections are known to
require the expression of cell-surface
receptors for critical pathogenetic steps.
This has prompted significant research
efforts towards the development of
pharmaceutical agents that block the
signals from cell-surface receptors.
While this current research shows great
promise, there is a strong need for new
therapeutic strategies that utilize the
mechanistic properties of cell-surface
receptors.
This technology describes a strategy
for artificially inducing the
internalization of surface receptors, and
thereby blocking the effects of the
ligands associated with that receptor.
This method employs bifunctional
ligands that bind to both a scavenger
receptor and a target receptor. As proof
of concept, the inventors Drs. Narazaki
and Tosato have shown that a ligand
capable of binding to the scavenger
receptor SREC–1 and the neuropilin-1
receptor NRP1 induces the
internalization of NRP1 and inhibits
NRP1 signaling. The inventors propose
that this strategy can be used to inhibit
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signaling from any target receptor if an
appropriate bifunctional ligand is used.
For example, the concept could be
expanded to other receptors, such as
HDL and LDL receptors. Likewise the
bifunctional ligand could include
specific antibodies or modified ligands
that recognize cell surface receptors of
biological importance. Accordingly, this
approach could be used to limit tumor
angiogenesis, limit tumor growth, block
metastasis formation, block
inflammation, block viral infection, and
treat just about any disease where we
identify a cell surface receptor as the
molecular basis for disease.
Applications:
• Method of inducing the
internalization of target receptors.
• Inhibiting diseases or conditions
associated with target receptors, such as
HIV infection, cancer, or angiogenesis.
• Treating diseases or conditions
associated with target receptors, such as
cancer, viral infections, or HIV
infections.
Market:
• Cancer is one of the leading causes
of death in the United States and it is
estimated that there will be more than
half a million deaths caused by cancer
in 2008.
• It is estimated that over one million
people in the U.S. are living with HIV/
AIDS and approximately 50,000 new
infections occur each year.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Masashi Narazaki and
Giovanna Tosato (NCI).
Patent Status: U.S. Provisional
Application No. 61/023,397 filed 24 Jan
2008 (HHS Reference No. E–250–2007/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney A.
Hastings; 301–451–7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Cellular Oncology, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize the
technology aimed at promoting selective
receptor internalization as a means to
neutralize ligand function and receptor
signaling. Please contact John D. Hewes,
PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Methods of Determining the Prognosis
of an Adenocarcinoma
Description of Technology: Available
for licensing and commercial
PO 00000
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63169
development is a novel method for
determining the prognosis of a subject
with adenocarcinoma in an organ, such
as the lung, and to aid in the selection
of a specific therapeutic regimen. Lung
adenocarcinoma (AC) is the
predominant histological subtype of
lung cancer, which is the leading cause
of cancer deaths worldwide. The risk of
metastasis remains substantial in AC
patients, even when a curative resection
of early-stage AC is performed. The
prognosis includes the determination of
the likelihood of survival, the likelihood
of metastasis, or both. The method
includes quantization of the expression
of a plurality of Th1 and Th2 cytokines
of interest in the adenocarcinoma and in
non-cancerous tissue in the organ.
Altered expression of one or more of the
Th1 and Th2 cytokines in the
adenocarcinoma as compared to the
non-cancerous tissue determines the
prognosis for the subject. The method is
capable of distinguishing patients with
lymph node metastasis versus those
with short term survival. Furthermore,
methods are provided for evaluating the
effectiveness of anti-cancer agents.
Applications: Prognosis of
adenocarcinoma, aid in the selection of
specific therapeutic regimens and
evaluation of the effectiveness of anticancer agents.
Development Status: The technology
is in early stage of development.
Inventors: Curtis C. Harris, Masahiro
Seike, Xin Wei Wang (NCI).
Patent Status: PCT Application No.
PCT/US2007/073637 filed 16 Jul 2007,
which published as WO 2008/009028
on 17 Jan 2008; claiming priority to 14
Jul 2006 (HHS Reference No. E–263–
2006/1–PCT–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Susan Ano, PhD;
301–435–5515; anos@mail.nih.gov.
Dated: October 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–25221 Filed 10–22–08; 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:
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63167-63169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25221]
-----------------------------------------------------------------------
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 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.
Gene Expression Profiling for Prognosis of a Non-Hodgkin Lymphoma
Description of Technology: Diffuse large B cell lymphoma (DLBCL) is
a quickly progressing cancer of the white blood cells, which is the
most common type of non-Hodgkin lymphoma. Most commonly, DLBCL is
treated aggressively with combination chemotherapy referred to as R-
CHOP. Fortunately, with this treatment more than half of these patients
can be cured or show remission. However, other patients do not respond
to treatment and succumb to the disease. Therefore, it would be helpful
to predict which patients are likely not to respond to R-CHOP and would
benefit from alternate treatments.
This invention provides gene microarrays and method of use claims
for a survival predictor calculated for DLBCL patients undergoing
combination therapy. By measuring the
[[Page 63168]]
gene expression of genes from cancer biopsies it is possible to
identify patients that are unlikely to be cured by R-CHOP and could
benefit from alternative treatments like anti-angiogenic drugs.
Applications: Diagnostic test for managing treatment of DLBCL
patients; Design and analysis of clinical trials in DLBCL.
Market: About 16,000 new cases per year of DLBCL in U.S.; Affects
mostly the middle-aged but it can afflict children.
Development Status: Clinical data is available.
Inventors: Louis M. Staudt (NCI).
Publication: A Rosenwald et al. The use of molecular profiling to
predict survival after chemotherapy for diffuse large-B-cell lymphoma.
N Engl J Med. 2002 Jun 20;346(25):1937-1947.
Patent Status: U.S. Provisional Application No. 61/059,678 filed 06
Jun 2008 (HHS Reference No. E-256-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Sabarni Chatterjee, PhD; 301-435-5587;
stansbej@mail.nih.gov.
A Simple Genetic Test for Kidney Disease
Description of Technology: This technology relates to methods of
diagnosing a predisposition to diseases that cause chronic kidney
disease (CKD) and end-stage kidney disease (ESKD). Variations in a
gene, non-muscle myosin IIA (MYH9), are associated with 79% of the risk
of focal segmental glomerulosclerosis (FSGS), the disease that causes
ESKD, in African Americans with HIV, and 56% of African Americans as a
whole. The variants are also associated with a 2-3 fold increased risk
for end-stage kidney disease (ESKD) associated with hypertension. The
variations are also present among European Americans, however they are
less common.
A simple genetic screening test has been developed that identifies
single nucleotide polymorphisms (SNP) and haplotypes in the non-muscle
myosin gene MYH9. These variants confer genetic risk for the following
kidney diseases: FSGS, collapsing glomerulopathy, HIV-associated
nephropathy, hypertensive kidney disease, sickle cell nephropathy,
lupus nephropathy, and possibly other kidney diseases.
Applications:
Facilitate rigorous population (i.e. all individuals)
screening for early kidney disease.
Screen individuals with hypertension, to identify
individuals who might benefit from more intensive therapy.
Screen kidney donors for MYH9 risk alleles to improve
renal allograft survival.
Screen patients with sickle cell disease to identify those
at increased risk for CKD.
Screen patients with lupus nephritis to identify those at
increased risk for CKD.
Screen patients with HIV-1 infection to identify those at
increased risk for kidney disease.
Screen patient with other kidney diseases, including
idiopathic and secondary kidney disease, where MYH9 mutations may alter
the propensity to develop kidney disease or the rate of progressive
renal function decline.
Pharmaceutical agents might be developed that reverse the
susceptibility phenotype, reducing propensity to CKD. These agents
might alter non-muscle myosin IIA function or its interactions with
critical molecular partners.
Market: An estimated 26 millions have CKD, with impaired glomerular
filtration rate and approximately 100,000 individuals in the United
States develop ESKD every year. The lifetime risk for ESKD is 7.5% of
individuals of African American descent and 2.1% for individuals of
European descent. Early identification of individuals with MYH9
variants who are at increased risk for CKD might substantially reduce
morbidity and mortality in this population, as impaired kidney function
is associated with death from cardiovascular disease even in patients
who do not progress to ESKD.
Development Status: Early-stage development for clinical
applications, including diagnostic testing and therapeutic
intervention.
Inventors: Cheryl A. Winkler (SAIC/NCI), George W. Nelson (SAIC/
NCI), Jeffrey B. Kopp (NIDDK), Michael W. Smith (SAIC/NCI), Randall C.
Johnson (SAIC/NCI).
Publication: JB Kopp et al. MYH9 is a major-effect risk gene for
focal segmental glomerulosclerosis. Nat Genet. 2008 Oct;40(10):1175-
1184.
Patent Status: U.S. Provisional Application No. 61/024,863 filed 30
Jan 2008 (HHS Reference No. E-090-2008/0-US-01); U.S. Provisional
Application No. 61/095,590 filed 09 Sep 2008 (HHS Reference No. E-090-
2008/1-US-01).
Licensing Status: Available for non-exclusive and exclusive
licensing.
Licensing Contact: Steve Standley, PhD; 301-435-4074;
sstand@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Genomic Diversity, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize genetic testing for MYH9. Please
contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Nanoparticles for Imaging and Treatment of Brain Tumors
Description of Technology: Malignant brain tumors, whether arising
within the brain or invading the brain from other tissues, are
difficult to treat. Conventional chemotherapy drugs do not reach
therapeutic levels in brain tumor tissue, and do not remain in brain
tumor tissue for long enough to enter brain tumor cells and kill them.
As a consequence, these chemotherapy drugs are not effective at
treating malignant brain tumors growing in patients, even though these
drugs are effective at killing brain tumor cells growing in culture.
This invention claims that intravenously administered
functionalized polyamidoamine (PAMAM) dendrimers of certain sizes can
selectively cross the blood-brain barrier (BBB) of malignant brain
tumors, and can accumulate over time within individual brain tumor
cells. Gadolinium and fluorescent probe conjugated dendrimers with
these properties can be used for simultaneous magnetic resonance and
fluorescence imaging of brain tumor cells. Since these nanoparticles
possess numerous additional surface functional groups, in addition to
being useful for multi-modality imaging, functionalized dendrimers can
also be useful for the simultaneous delivery of cytotoxic drugs and
inhibitors of tumor cell metabolic or migratory pathways.
Advantages:
Intravenously administered nanoparticles selectively cross
the BBB of brain tumors and accumulate within brain tumor cells but not
normal brain cells.
Nanoparticles accumulate in and are retained in brain
tumor tissue for long enough to result in the effective uptake of
nanoparticles by individual brain tumor cells.
Nanoparticle size can be adjusted to achieve the desired
particle blood half-life.
A wide variety of agents can be attached to the functional
groups on the nanoparticle exterior.
Applications:
[[Page 63169]]
Anatomic and metabolic imaging of brain and spinal cord
tumors for diagnostic and therapeutic purposes.
Intravenous treatment of brain and spinal cord tumors.
Imaging of intravenous drug delivery to brain and spinal
cord tumors.
Potential to be used for imaging and treatment of other
neurological disorders in which the BBB becomes porous.
Market: In 2008, it is estimated that malignant tumors of the brain
and spinal cord will account for about 1.5% of all cancers and 2.3% of
all expected cancer-related deaths.
Development Status: Early stage development; Pre-clinical data
available.
Inventor: Hemant Sarin (CC).
Patent Status: U.S. Provisional Application No. 61/055,328 filed 22
May 2008 (HHS Reference No. E-063-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
Induced Internalization of Surface Receptors
Description of Technology: Cell-surface receptors are responsible
for the biological activities of many molecules. Specific ligands bind
to them, causing the cell-surface receptors to internalize or bring the
receptor and ligand inside the cell. A number of diseases, including
cancer, metabolic disorders, and viral infections are known to require
the expression of cell-surface receptors for critical pathogenetic
steps. This has prompted significant research efforts towards the
development of pharmaceutical agents that block the signals from cell-
surface receptors. While this current research shows great promise,
there is a strong need for new therapeutic strategies that utilize the
mechanistic properties of cell-surface receptors.
This technology describes a strategy for artificially inducing the
internalization of surface receptors, and thereby blocking the effects
of the ligands associated with that receptor. This method employs
bifunctional ligands that bind to both a scavenger receptor and a
target receptor. As proof of concept, the inventors Drs. Narazaki and
Tosato have shown that a ligand capable of binding to the scavenger
receptor SREC-1 and the neuropilin-1 receptor NRP1 induces the
internalization of NRP1 and inhibits NRP1 signaling. The inventors
propose that this strategy can be used to inhibit signaling from any
target receptor if an appropriate bifunctional ligand is used. For
example, the concept could be expanded to other receptors, such as HDL
and LDL receptors. Likewise the bifunctional ligand could include
specific antibodies or modified ligands that recognize cell surface
receptors of biological importance. Accordingly, this approach could be
used to limit tumor angiogenesis, limit tumor growth, block metastasis
formation, block inflammation, block viral infection, and treat just
about any disease where we identify a cell surface receptor as the
molecular basis for disease.
Applications:
Method of inducing the internalization of target
receptors.
Inhibiting diseases or conditions associated with target
receptors, such as HIV infection, cancer, or angiogenesis.
Treating diseases or conditions associated with target
receptors, such as cancer, viral infections, or HIV infections.
Market:
Cancer is one of the leading causes of death in the United
States and it is estimated that there will be more than half a million
deaths caused by cancer in 2008.
It is estimated that over one million people in the U.S.
are living with HIV/AIDS and approximately 50,000 new infections occur
each year.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Masashi Narazaki and Giovanna Tosato (NCI).
Patent Status: U.S. Provisional Application No. 61/023,397 filed 24
Jan 2008 (HHS Reference No. E-250-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Whitney A. Hastings; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Cellular Oncology, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize the technology aimed at promoting
selective receptor internalization as a means to neutralize ligand
function and receptor signaling. Please contact John D. Hewes, PhD at
301-435-3121 or hewesj@mail.nih.gov for more information.
Methods of Determining the Prognosis of an Adenocarcinoma
Description of Technology: Available for licensing and commercial
development is a novel method for determining the prognosis of a
subject with adenocarcinoma in an organ, such as the lung, and to aid
in the selection of a specific therapeutic regimen. Lung adenocarcinoma
(AC) is the predominant histological subtype of lung cancer, which is
the leading cause of cancer deaths worldwide. The risk of metastasis
remains substantial in AC patients, even when a curative resection of
early-stage AC is performed. The prognosis includes the determination
of the likelihood of survival, the likelihood of metastasis, or both.
The method includes quantization of the expression of a plurality of
Th1 and Th2 cytokines of interest in the adenocarcinoma and in non-
cancerous tissue in the organ. Altered expression of one or more of the
Th1 and Th2 cytokines in the adenocarcinoma as compared to the non-
cancerous tissue determines the prognosis for the subject. The method
is capable of distinguishing patients with lymph node metastasis versus
those with short term survival. Furthermore, methods are provided for
evaluating the effectiveness of anti-cancer agents.
Applications: Prognosis of adenocarcinoma, aid in the selection of
specific therapeutic regimens and evaluation of the effectiveness of
anti-cancer agents.
Development Status: The technology is in early stage of
development.
Inventors: Curtis C. Harris, Masahiro Seike, Xin Wei Wang (NCI).
Patent Status: PCT Application No. PCT/US2007/073637 filed 16 Jul
2007, which published as WO 2008/009028 on 17 Jan 2008; claiming
priority to 14 Jul 2006 (HHS Reference No. E-263-2006/1-PCT-01).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Susan Ano, PhD; 301-435-5515; anos@mail.nih.gov.
Dated: October 14, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-25221 Filed 10-22-08; 8:45 am]
BILLING CODE 4140-01-P
