Government-Owned Inventions; Availability for Licensing, 81626-81628 [2010-32669]
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
proteases: cruzain, rhodesain, and
TbCatB. J Med Chem. 2010 Jan
14;53(1):52–60. [PubMed: 19908842]
Patent Status: PCT Application No.
PCT/US2009/063078 filed 03 Nov 2009,
which published as WO 2010/059418
on 27 May 2010 (HHS Reference No. E–
267–2008/0–PCT–02)
Licensing Status: Available for
licensing.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov.
Collaborative Research Opportunity:
The NIH Chemical Genomics Center
(NCGC) is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize appropriate lead
compounds described in the patent
application. Please contact Dr. Craig J.
Thomas (craigt@nhgri.nih.gov) or Claire
Driscoll (cdriscol@mail.nih.gov),
Director of the NHGRI Technology
Transfer Office, for more information.
emcdonald on DSK2BSOYB1PROD with NOTICES
A Novel, Inhibitory Platelet Surface
Protein (TREM Like Transcript, TLT–1):
New Target for the Treatment of
Cancer, Infectious Diseases, Cardiac
Diseases, and Platelet-Associated
Disorders
Description of Technology: Triggering
Receptors in Myeloid Cells (TREM)
recently were discovered to modulate
innate and adaptive immunity.
Specifically, TREM1 amplifies the
response to sepsis in innate immunity
by activating neutrophils and other
leukocytes; and TREM2 potentiates
dendritic cell maturation in adaptive
immunity.
This invention describes a novel,
inhibitory platelet surface protein
known as TREM like Transcript (TLT–
1). TLT–1 is the first inhibitory receptor
discovered to reside within the TREM
gene locus. Structurally, TLT–1 also
possesses inhibitory domains that
indicate this regulatory function. TLT–
1 is highly expressed in peripheral
blood platelets and may modulate many
other types of myeloid cells.
Additionally, the invention describes
specific, human, single chain antibodies
(scFvs) that recognize TLT–1.
Applications
• This discovery implies the receptor
has an important regulatory role in both
innate and adaptive immunity.
• TLT–1 is a potential therapeutic
target for thrombosis and other plateletassociated disorders, as well as immune
disorders, cancer, septic shock,
infectious disease, stroke, heart disease,
myocardial infarction, vascular
disorders.
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• Detection of soluble TLT–1 in
patient plasma suggests the protein is a
marker of ongoing coagulopathies.
• Defective platelet aggregation in
TLT–1 null mice confirms a role for the
protein in regulation of thrombosis
associated with inflammation.
• In vitro proof of concept data
available—Three of the anti-TLT–1
scFvs inhibit thrombin-induced
aggregation of human platelets in a
dose-dependent manner.
• Complete human origin of these
antibodies suggests negligible
immunogenicity and minimizes the
problem of adverse immune responses
in human therapy.
• Target validation is complete. TLT–
1 null mice demonstrate defects in
platelet aggregation with no gross
bleeding defect.
Development Status: In vitro
experiments completed. Target
validation with null mice completed. In
vivo animal studies with scFv are
currently ongoing.
Inventors: Toshiyuki Mori et al. (NCI)
Related Publication: Giomarelli B,
Washington VA, Chisholm MM, Quigley
L, McMahon JB, Mori T, McVicar DW.
Inhibition of thrombin-induced platelet
aggregation using human single-chain
Fv antibodies specific for TREM-like
transcript-1. Thromb Haemost. 2007
Jun;97(6):955–963. [PubMed: 17549298]
Patent Status: U.S. Patent No.
7,553,936 issued on 30 Jun 2009 (HHS
Reference No. E–177–2006/0–US–01)
Licensing Status: Available for
licensing.
Licensing Contact: Betty B. Tong,
PhD; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute’s
Molecular Targets Development
Program is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize antibodies that react
specifically with TLT–1. Please contact
John D. Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: December 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–32629 Filed 12–27–10; 8:45 am]
BILLING CODE 4140–01–P
Frm 00067
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
Advantages
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fmt 4703
Sfmt 4703
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Engineered Biological Pacemakers
Description of Technology: A common
symptom of many heart diseases is an
abnormal heart rhythm or arrhythmia.
While effectively improving the lives of
many patients, implantable pacemakers
have significant limitations such as
limited power sources, risk of
infections, potential for interference
from other devices, and absence of
autonomic rate modulation.
The technology consists of biological
pacemakers engineered to generate
normal heart rhythm. The biological
pacemakers include cardiac cells or
cardiac-like cells derived from
embryonic stem cells or mesenchymal
stem cells. The biological pacemakers
naturally integrate into the heart. Their
generation of rhythmic electric impulses
involves coupling factors, such as
cAMP-dependent PKA and Ca2+
-dependent CaMK II, which are
regulatory proteins capable of
modulating/enhancing interactions (i.e.
coupling) of the sarcoplasmic reticulumbased, intracellular Ca2+ clock and the
surface membrane voltage clock, thereby
converting irregularly or rarely
spontaneously active cells into
pacemakers generating rhythmic
excitations.
E:\FR\FM\28DEN1.SGM
28DEN1
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
emcdonald on DSK2BSOYB1PROD with NOTICES
Applications: This technology can be
utilized in heart disease characterized
by arrhythmia or situations requiring an
implantable cardiac pacemaker.
Advantages: In contrast to current
implantable cardiac pacemaker
technology, this technology is not
externally powered, has a lower risk of
infection, has decreased potential for
interference from other devices, and has
full autonomic rate modulation.
Development Status: Early stage.
Inventors: Victor A. Maltsev et al.
(NIA)
Publications:
1. VA Maltsev and EG Lakatta.
Synergism of coupled subsarcolemmal
Ca2+ clocks and sarcolemmal voltage
clocks confers robust and flexible
pacemaker function in a novel
pacemaker cell model. Am J Physiol
Heart Circ Physiol. 2009
Mar;296(3):H594–H615. [PubMed:
19136600]
2. VA Maltsev and EG Lakatta.
Dynamic interactions of an intracellular
Ca2+ clock and membrane ion channel
clock underlie robust initiation and
regulation of cardiac pacemaker
function. Cardiovasc Res. 2008 Jan
15;77(2):274–284. [PubMed: 18006441]
Patent Status: PCT Application No.
PCT/US2010/035823 filed 21 May 2010
(HHS Reference No. E–134–2009/0–
PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity:
The National Institute on Aging,
Cellular Biophysics Section, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact Vio Conley at 301–496–0477 or
conleyv@mail.nih.gov for more
information.
Method of Detecting and Quantifying
Contaminants in Heparin Preparations
Description of Technology: Heparin is
a naturally occurring acidic
carbohydrate produced commercially
from extracts of animal tissues (such as
bovine lung or porcine intestine) and is
used in the treatment of a wide range of
diseases in addition to their classic
anticoagulant activity. Heparin is also
used to coat many medical devices,
such as catheters, syringes, stents and
filters. Recently, certain lots of heparin
were associated with serious side effects
and adverse events. Recalls were issued
in multiple countries and it became
evident that there was an extensive
problem with heparin manufacture.
VerDate Mar<15>2010
22:37 Dec 27, 2010
Jkt 223001
Traditional tests may not be able to
determine the presence of
contaminant(s) without lyophilizing and
concentrating each sample and may not
be suitable for testing finished medical
devices. Therefore, there is a
demonstrated need to develop other
assay methods for detecting
contaminating oversulfated compounds
of any source in heparin and heparin
derived products.
This technology relates to methods for
detecting and/or quantifying
oversulfated glycosaminoglycans based
on inhibition of nucleic acid
polymerases and resistance to
enzymatic degradation. It also relates to
the use of these methods to screen and
quantify pharmaceutical preparations
such as heparin preparations for
oversulfated contaminants.
Potential Applications: Robust,
simple and effective method for
detecting and optionally quantifying
oversulfated contaminants in heparin
preparations.
Development Status: The method has
been developed and qualified for
sensitivity and identity, but full
validation and commercialization have
not been undertaken.
Inventor: Daniela Verthelyi et al.
(FDA)
Publication: C Tami, M Puig, JC
Reepmeyer, H Ye, DA D’Avignon,
L Buhse, D Verthelyi. Inhibition of Taq
polymerase as a method for screening
heparin for oversulfated contaminants.
Biomaterials 2008 Dec;29(36):4808–
4814. [PubMed: 18801571]
Patent Status: PCT Application No.
PCT/US2009/056263 filed 08 Sep 2009,
which published as WO 2010/030608
on 18 Mar 2010 (HHS Reference No.
E–227–2008/0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity:
The FDA, Division of Therapeutic
Proteins, Laboratory of Immunology, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
high throughput screening test for
oversulfated glycosamineglycan
contaminants in heparin. Please contact
Daniela Verthelyi at
daniela.verthelyi@fda.hhs.gov or Alice
Welch at alice.welch@fda.hhs.gov for
more information.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
81627
Method for the Diagnosis and Prognosis
of Age-Related Cardiovascular
Disorders
Description of Technology: NIH
investigators have discovered a method
for the diagnosis and prognosis of
cardiovascular aging. Current
methodologies include the measurement
of patient lipid profiles or expression of
up to two proteins. In contrast, this
technology utilizes the expression levels
of a panel of proteins not previously
known to be related to cardiovascular
aging and may prove to be a more
accurate diagnostic or prognostic of
cardiovascular aging than currently
available tests or it may improve the
accuracy of currently available tests
when used in concert.
The technology relates to methods for
determining susceptibility to having an
extremely common age-associated
vascular disorder. It also describes the
subsequent use of these proteins as
markers for disease. While the
underlying cellular and molecular
mechanisms of age-related vascular
disease remain largely undefined, the
expression levels of the genes described
in this technology have been
empirically determined to differ
between healthy and age-inflamed
arterial tissue. Further, this technology
includes a companion mass
spectroscopic-based methodology for
reproducible quantification of specific
expression levels of interest.
Application: Diagnosis of age-related
vascular disorder.
Development Status: Early stage.
Inventors: Mingyi Wang et al. (NIA).
Patent Status: PCT Application No.
PCT/US2010/024816 filed 19 Feb 2010,
which published as WO 2010/096713
on 26 Aug 2010 (HHS Reference No. E–
219–2008/0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
MHPM; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity:
The National Institute on Aging,
Cardiovascular Biology Unit—Vascular
Group, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize idea of how to assess and
retard accelerated arterial aging and its
attendant risks for atherosclerosis and
hypertension. Please contact Vio Conley
at 301–496–0477 or
conleyv@mail.nih.gov for more
information.
E:\FR\FM\28DEN1.SGM
28DEN1
81628
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
emcdonald on DSK2BSOYB1PROD with NOTICES
Identification of Subjects Likely To
Benefit From Copper Treatment
Description of Technology: Menkes
disease is an infantile onset X-linked
recessive neurodegenerative disorder
caused by deficiency or dysfunction of
a copper-transporting ATPase, ATP7A.
The clinical and pathologic features of
this condition reflect decreased
activities of enzymes that require copper
as a cofactor, including dopamine-bhydrolase, cytochrome c oxidase and
lysyl oxidase. Recent studies indicate
that ATP7A normally responds to
N-methyl-D-aspartate receptor
activation in the brain, and an impaired
response probably contributes to the
neuropathology of Menkes disease.
Affected infants appear healthy at birth
and develop normally for 6 to 8 weeks.
Subsequently, hypotonia, seizures and
failure to thrive occur and death by 3
years of age is typical. Occipital horn
syndrome (OHS) is also caused by
mutations in the copper transporting
ATPase ATP7A, although its symptoms
are milder than Menkes syndrome,
including occipital horns and lax skin
and joints.
Treatment with daily copper
injections may improve the outcome in
Menkes disease if commenced within
days after birth; however, newborn
screening for this disorder is not
available and early detection is difficult
because clinical abnormalities in
affected newborns are absent or subtle.
Moreover, the usual biochemical
markers (low serum copper and
ceruloplasmin) are unreliable predictors
in the neonatal period, since levels in
healthy newborns are low and overlap
with those in infants with Menkes
disease. Although molecular diagnosis
is available, its use is complicated by
the diversity of mutation types and the
large size of ATP7A (about 140kb).
Thus, there is a need for improved
methods for early detection of infants
with Menkes disease or OHS in order to
improve outcomes.
This technology relates to methods of
identifying individuals who may benefit
from treatment with copper, particularly
those having Menkes disease or
Occipital Horn Syndrome.
Inventor: Stephen G. Kaler (NICHD).
Publication: SG Kaler, CS Holmes, DS
Goldstein, JR Tang, SC Godwin,
A Donsante, CJ Liew, S Sato, N
Patronas. Neonatal diagnosis and
treatment of Menkes disease. N Engl J
Med. 2008 Feb 7;358(6):605–614.
[PubMed: 18256395]
Patent Status: PCT Application No.
PCT/US2008/078966 filed 06 Oct 2008,
which published as WO 2010/042102
VerDate Mar<15>2010
22:37 Dec 27, 2010
Jkt 223001
on 15 Apr 2010 (HHS Reference No.
E–186–2008/0–PCT–01).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity:
The National Institute of Child Health
and Human Development, Division of
Intramural Research, Molecular
Medicine Program, Unit on Pediatric
Genetics, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize population-based
newborn screening for Menkes disease
and related disorders of copper
transport in order to identify subjects
likely to benefit from copper injections
and other treatments. Please contact
Alan Hubbs, PhD at 301–594–4263 or
hubbsa@mail.nih.gov for more
information.
Dated: December 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–32669 Filed 12–27–10; 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:
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
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
be required to receive copies of the
patent applications.
A New Class of Antibiotics: Natural
Inhibitors of Bacterial Cytoskeletal
Protein FtsZ to Fight Drug-susceptible
and Multi-drug Resistant Bacteria
Description of Technology: The risk of
infectious diseases epidemic has been
alarming in recent decades. This is not
only because of the increase incident of
so-called ‘‘super bugs,’’ but also because
of the scarce number of potential
antibiotics in the pipeline. Currently,
the need for new antibiotics is greater
than ever! The present invention by the
National Institute of Diabetes and
Digestive and Kidney Disease (NIDDK),
part of the National Institute of Health
(NIH), address this urgent need. The
invention is a new class of
chrysophaentin antibiotics that inhibit
the growth of broad-spectrum, drugsusceptible, and drug-resistant bacteria.
Derived from the yellow algae
Chrysophaeum taylori, the inventor has
extracted 8 small molecules of natural
products and tested for antimicrobial
activity against drug resistant bacteria,
methicillin-resistant Staphylococcus
aureus (MRSA) and vancomycinresistant Enterococcus faecalis (VRE), as
well as other drug susceptible strains.
Structurally, the molecules represent a
new class of antibiotic that also likely
work through a distinct mechanism of
action from that of current antibiotics,
which is key for the further
development of antibiotics that inhibit
drug-resistant strains.
The bacterial cytoskeletal protein FtsZ
is a GTPase and has structural homology
to the eukaryotic cytoskeletal protein
tubulin, but lacks significant sequence
similarity. FtsZ is essential for bacterial
cell division. It is responsible for Z-ring
assembly in bacteria, which leads to
bacterial cell division. Experiments
show that the disclosed compounds are
competitive inhibitors of GTP binding to
FtsZ, and must bind in the GTP-binding
site of FtsZ. Inhibition of FtsZ stops
bacterial cell division and is a validated
target for new antimicrobials. FtsZ is
highly conserved among all bacteria,
making it a very attractive antimicrobial
target.
Applications:
• Therapeutic potential for curing
bacterial infections in vivo, including
for clinical and veterinary applications.
• Antiseptics in hospital settings.
• Since FtsZ is structurally similar,
but does not share sequence homology
to eukaryotic cytoskeletal protein
tubulin, these compounds may have
antitumor properties against some
cancer types or cell lines.
Advantages:
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81626-81628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32669]
-----------------------------------------------------------------------
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.
Engineered Biological Pacemakers
Description of Technology: A common symptom of many heart diseases
is an abnormal heart rhythm or arrhythmia. While effectively improving
the lives of many patients, implantable pacemakers have significant
limitations such as limited power sources, risk of infections,
potential for interference from other devices, and absence of autonomic
rate modulation.
The technology consists of biological pacemakers engineered to
generate normal heart rhythm. The biological pacemakers include cardiac
cells or cardiac-like cells derived from embryonic stem cells or
mesenchymal stem cells. The biological pacemakers naturally integrate
into the heart. Their generation of rhythmic electric impulses involves
coupling factors, such as cAMP-dependent PKA and Ca\2+\ -dependent CaMK
II, which are regulatory proteins capable of modulating/enhancing
interactions (i.e. coupling) of the sarcoplasmic reticulum-based,
intracellular Ca\2+\ clock and the surface membrane voltage clock,
thereby converting irregularly or rarely spontaneously active cells
into pacemakers generating rhythmic excitations.
[[Page 81627]]
Applications: This technology can be utilized in heart disease
characterized by arrhythmia or situations requiring an implantable
cardiac pacemaker.
Advantages: In contrast to current implantable cardiac pacemaker
technology, this technology is not externally powered, has a lower risk
of infection, has decreased potential for interference from other
devices, and has full autonomic rate modulation.
Development Status: Early stage.
Inventors: Victor A. Maltsev et al. (NIA)
Publications:
1. VA Maltsev and EG Lakatta. Synergism of coupled subsarcolemmal
Ca\2+\ clocks and sarcolemmal voltage clocks confers robust and
flexible pacemaker function in a novel pacemaker cell model. Am J
Physiol Heart Circ Physiol. 2009 Mar;296(3):H594-H615. [PubMed:
19136600]
2. VA Maltsev and EG Lakatta. Dynamic interactions of an
intracellular Ca\2+\ clock and membrane ion channel clock underlie
robust initiation and regulation of cardiac pacemaker function.
Cardiovasc Res. 2008 Jan 15;77(2):274-284. [PubMed: 18006441]
Patent Status: PCT Application No. PCT/US2010/035823 filed 21 May
2010 (HHS Reference No. E-134-2009/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity: The National Institute on
Aging, Cellular Biophysics Section, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize this technology. Please
contact Vio Conley at 301-496-0477 or conleyv@mail.nih.gov for more
information.
Method of Detecting and Quantifying Contaminants in Heparin
Preparations
Description of Technology: Heparin is a naturally occurring acidic
carbohydrate produced commercially from extracts of animal tissues
(such as bovine lung or porcine intestine) and is used in the treatment
of a wide range of diseases in addition to their classic anticoagulant
activity. Heparin is also used to coat many medical devices, such as
catheters, syringes, stents and filters. Recently, certain lots of
heparin were associated with serious side effects and adverse events.
Recalls were issued in multiple countries and it became evident that
there was an extensive problem with heparin manufacture.
Traditional tests may not be able to determine the presence of
contaminant(s) without lyophilizing and concentrating each sample and
may not be suitable for testing finished medical devices. Therefore,
there is a demonstrated need to develop other assay methods for
detecting contaminating oversulfated compounds of any source in heparin
and heparin derived products.
This technology relates to methods for detecting and/or quantifying
oversulfated glycosaminoglycans based on inhibition of nucleic acid
polymerases and resistance to enzymatic degradation. It also relates to
the use of these methods to screen and quantify pharmaceutical
preparations such as heparin preparations for oversulfated
contaminants.
Potential Applications: Robust, simple and effective method for
detecting and optionally quantifying oversulfated contaminants in
heparin preparations.
Development Status: The method has been developed and qualified for
sensitivity and identity, but full validation and commercialization
have not been undertaken.
Inventor: Daniela Verthelyi et al. (FDA)
Publication: C Tami, M Puig, JC Reepmeyer, H Ye, DA D'Avignon, L
Buhse, D Verthelyi. Inhibition of Taq polymerase as a method for
screening heparin for oversulfated contaminants. Biomaterials 2008
Dec;29(36):4808-4814. [PubMed: 18801571]
Patent Status: PCT Application No. PCT/US2009/056263 filed 08 Sep
2009, which published as WO 2010/030608 on 18 Mar 2010 (HHS Reference
No. E-227-2008/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity: The FDA, Division of
Therapeutic Proteins, Laboratory of Immunology, is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this high
throughput screening test for oversulfated glycosamineglycan
contaminants in heparin. Please contact Daniela Verthelyi at
daniela.verthelyi@fda.hhs.gov or Alice Welch at alice.welch@fda.hhs.gov
for more information.
Method for the Diagnosis and Prognosis of Age-Related Cardiovascular
Disorders
Description of Technology: NIH investigators have discovered a
method for the diagnosis and prognosis of cardiovascular aging. Current
methodologies include the measurement of patient lipid profiles or
expression of up to two proteins. In contrast, this technology utilizes
the expression levels of a panel of proteins not previously known to be
related to cardiovascular aging and may prove to be a more accurate
diagnostic or prognostic of cardiovascular aging than currently
available tests or it may improve the accuracy of currently available
tests when used in concert.
The technology relates to methods for determining susceptibility to
having an extremely common age-associated vascular disorder. It also
describes the subsequent use of these proteins as markers for disease.
While the underlying cellular and molecular mechanisms of age-related
vascular disease remain largely undefined, the expression levels of the
genes described in this technology have been empirically determined to
differ between healthy and age-inflamed arterial tissue. Further, this
technology includes a companion mass spectroscopic-based methodology
for reproducible quantification of specific expression levels of
interest.
Application: Diagnosis of age-related vascular disorder.
Development Status: Early stage.
Inventors: Mingyi Wang et al. (NIA).
Patent Status: PCT Application No. PCT/US2010/024816 filed 19 Feb
2010, which published as WO 2010/096713 on 26 Aug 2010 (HHS Reference
No. E-219-2008/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, MHPM; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity: The National Institute on
Aging, Cardiovascular Biology Unit--Vascular Group, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
idea of how to assess and retard accelerated arterial aging and its
attendant risks for atherosclerosis and hypertension. Please contact
Vio Conley at 301-496-0477 or conleyv@mail.nih.gov for more
information.
[[Page 81628]]
Identification of Subjects Likely To Benefit From Copper Treatment
Description of Technology: Menkes disease is an infantile onset X-
linked recessive neurodegenerative disorder caused by deficiency or
dysfunction of a copper-transporting ATPase, ATP7A. The clinical and
pathologic features of this condition reflect decreased activities of
enzymes that require copper as a cofactor, including dopamine-[beta]-
hydrolase, cytochrome c oxidase and lysyl oxidase. Recent studies
indicate that ATP7A normally responds to N-methyl-D-aspartate receptor
activation in the brain, and an impaired response probably contributes
to the neuropathology of Menkes disease. Affected infants appear
healthy at birth and develop normally for 6 to 8 weeks. Subsequently,
hypotonia, seizures and failure to thrive occur and death by 3 years of
age is typical. Occipital horn syndrome (OHS) is also caused by
mutations in the copper transporting ATPase ATP7A, although its
symptoms are milder than Menkes syndrome, including occipital horns and
lax skin and joints.
Treatment with daily copper injections may improve the outcome in
Menkes disease if commenced within days after birth; however, newborn
screening for this disorder is not available and early detection is
difficult because clinical abnormalities in affected newborns are
absent or subtle. Moreover, the usual biochemical markers (low serum
copper and ceruloplasmin) are unreliable predictors in the neonatal
period, since levels in healthy newborns are low and overlap with those
in infants with Menkes disease. Although molecular diagnosis is
available, its use is complicated by the diversity of mutation types
and the large size of ATP7A (about 140kb). Thus, there is a need for
improved methods for early detection of infants with Menkes disease or
OHS in order to improve outcomes.
This technology relates to methods of identifying individuals who
may benefit from treatment with copper, particularly those having
Menkes disease or Occipital Horn Syndrome.
Inventor: Stephen G. Kaler (NICHD).
Publication: SG Kaler, CS Holmes, DS Goldstein, JR Tang, SC Godwin,
A Donsante, CJ Liew, S Sato, N Patronas. Neonatal diagnosis and
treatment of Menkes disease. N Engl J Med. 2008 Feb 7;358(6):605-614.
[PubMed: 18256395]
Patent Status: PCT Application No. PCT/US2008/078966 filed 06 Oct
2008, which published as WO 2010/042102 on 15 Apr 2010 (HHS Reference
No. E-186-2008/0-PCT-01).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
Collaborative Research Opportunity: The National Institute of Child
Health and Human Development, Division of Intramural Research,
Molecular Medicine Program, Unit on Pediatric Genetics, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
population-based newborn screening for Menkes disease and related
disorders of copper transport in order to identify subjects likely to
benefit from copper injections and other treatments. Please contact
Alan Hubbs, PhD at 301-594-4263 or hubbsa@mail.nih.gov for more
information.
Dated: December 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-32669 Filed 12-27-10; 8:45 am]
BILLING CODE 4140-01-P
