Government-Owned Inventions; Availability for Licensing, 73779-73781 [E5-7249]
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Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices
III. Opportunity to Submit Domestic
Information
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
As required by section 201(d)(2)(A) of
the CSA (21 U.S.C. 811(d)(2)(A)), FDA,
on behalf of HHS, invites interested
persons to submit comments regarding
the nine named drugs. Any comments
received will be considered by HHS
when it prepares a scientific and
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will forward a scientific and medical
evaluation of these drugs to WHO,
through the Secretary of State, for
WHO’s consideration in deciding
whether to recommend international
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things, the manufacture and distribution
(import/export) of these drugs and could
impose certain recordkeeping
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HHS will not now make any
recommendations to WHO regarding
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Instead, HHS will defer such
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National Institutes of Health
IV. Comments
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ADDRESSES) written or electronic
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abbreviated comment period is
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Dated: December 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23958 Filed 12–12–05; 8:45 am]
BILLING CODE 4160–01–S
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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.
Tri-Functional Nanospheres
Yun-bo Shi (NICHD) et al.
U.S. Patent Application No. 11/135,380
filed 24 May 2005 (HHS Reference
No. E–145–2005/0–US–01).
Licensing Contact: Cristina
Thalhammer-Reyero; 301/435–4507;
thalhamc@mail.nih.gov.
Available for licensing and
commercial development is an
invention related to ‘‘biofunctional’’ trifunctional nanospheres (TFNs) or multifunctional nanospheres (MFNs)
obtained by binding one or more
biomaterials, such as folate, IgG, biotin
or streptavidin, to fluorescent-magnetic
bifunctional nanospheres (BFNs).
Unlike other BFNs available, which are
virtually all based on having a magnetic
core, the present invention is based on
mesoporous BFNs with hydrophobic
inner cavities. The properties of the
TFNs of the subject invention have
superior qualities for use for the various
applications that require aqueous
solutions.
Nanospheres are becoming the
materials of choice for a rapidly
increasing number of pharmaceutical
and biomedical applications, including
the use of quantum dots (QDs) and
magnetic nanoparticles. Materials with
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the combined function of fluorescent
labeling and magnetic separation have
many applications in biomedical
science, including those resulting from
the encapsulation of both particles in
polymer microcapsules. However, these
related prior technologies are
predominantly dependent on core-shell
type technologies. Typically, a magnetic
material such as magnetite or a
fluorescent particle such as a QD is used
as a core. Such a core-shell structure is
chemically unstable and
disadvantageous for fluorescence
applications because the shell tends to
absorb either or both of the excitation
and emission lights, thus dimming the
fluorescent signal. The nanoparticles of
this invention are composed of a
mesoporous copolymer, a magnetic
material embedded into the mesoporous
copolymer, a fluorescent nanomaterial
concurrently embedded into the
mesoporous copolymer, and one or
more biomaterials coupled to the
mesoporous copolymer.
TFNs and MFNs have multiple uses.
When the TFNs are labeled by a single
biomaterial, the nanoparticles may
specifically bind to a cell, or a protein
or any other moiety that to which the
biomaterial specifically binds. For
instance, the biomaterial may be a small
molecule ligand that is specifically
bound by a cell surface receptor. MFNs
in which two bioagents are coupled to
single BFNs allow using one bioagent to
target a macromolecule or a cell and
using the second one to alter the
function/properties of the
macromolecule or cell, e.g., using a
protein to target a cell and using a toxin
or cell death protein to kill the targeted
cell, or using a chemical or protein to
target a protein within a complex and
another one to alter the function of a
different component of the complex.
The technology is further described in
‘‘Biofunctionalization of fluorescentmagnetic-biofunctional nanospheres
and their applications,’’ Guo-Ping Wang,
Er-Qun Song, Hai-Yan Xie, Zhi-Ling
Zhang, Zhi-Quan Tian, Chao Zuo, DaiWen Pang, Dao-Cheng Wu and Yun-Bo
Shi; Chemical Communications, 2005,
(34), 4276–4278; DOI: 10.1039/
b508075d.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Efficient Growth of Wild-Type Hepatitis
A Virus in Cell Culture for
Development of Live Vaccines
Gerarado Kaplan and Krishnamurthy
Konduru (FDA).
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Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices
U.S. Provisional Application No. 60/
684,526 filed 28 Jun 2005 (HHS
Reference No. E–151–2004/0–US–01).
Licensing Contact: Chekesha S.
Clingman; 301/435–5018;
clingmac@mail.nih.gov.
This technology relates to the
development of recombinant wild-type
and attenuated Hepatitis A Virus (HAV)
vectors capable of growing in cell
culture and useful for development of a
live HAV vaccine. This technology also
encompasses HAV vectors coding for
markers that allow the selection of cell
lines that support the efficient growth of
wild-type and attenuated HAV in
culture for diagnostic and
environmental monitoring purposes.
The currently available killed HAV
vaccines are expensive and require a
two dose schedule to confer immunity
for approximately two decades. Inability
of wild-type (wt) HAV to grow
efficiently in cell culture has been the
major roadblock to developing a live
HAV vaccine, which could confer
lifelong immunity, be cost-effective and
allow eradication of the virus. The
inventors have developed recombinant
infectious HAV coding for resistance
genes against antibiotics that inhibits
translation in mammalian cells and
provides a selective phenotype that
allows selection of cells expressing the
phenotype within one week. Also, the
inventors have created methods of
selecting cells permissive for replication
of wild-type and not overly attenuated
HAV by utilizing selective or screened
phenotypes and antibiotic resistant cell
techniques.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Internal Control Nucleic Acid Molecule
for Real-Time Polymerase Chain
Reaction
Michael Vickery, Angelo DePaola,
George Blackstone (FDA).
U.S. Provisional Application No. 60/
471,121 filed 16 May 2003 (HHS
Reference No. E–213–2003/0–US–01);
PCT Application No. PCT/US04/15175
filed 14 May 2004 (HHS Reference
No. E–213–2003/0–PCT–02).
Licensing Contact: Michael Shmilovich;
301/435–5019;
shmilovm@mail.nih.gov.
The invention provides a PCR internal
control system for use in both real-time
PCR (also known as kinetic or Q–PCR)
and conventional PCR. This flexible
system has a number of novel design
qualities which make it universally
adaptable for use in virtually any realtime or conventional PCR assay,
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positions and catalyzes the reactants
favorably to form the inhibitor. The
bisubstrate inhibitor is likely to
accumulate in the cell because it is
stable, highly charged and thus will not
pass through cell membranes. The
targeted acetyltransferase will thus be
inhibited and therapeutic actions
realized.
The varied actions of
acetyltransferases in biochemical
processes offer many potential
therapeutic targets. Acetylation
inactivates drugs and endogenous
ligands so inhibitors could, for example,
enhance the effectiveness of antibiotics
where antibiotic resistance is due to a
high level of acetylation. In the case of
AANAT, acetylation inactivates
serotonin and is the rate limiting step in
the formation of melatonin. Inhibition of
AANAT will thus decrease melatonin
production and increase serotonin
levels. Melatonin is a pineal hormone
that has endocrinological,
neurophysiological, and behavioral
functions. Since melatonin and
serotonin are implicated in several types
of mood disorders, inhibition of
AANAT could have valuable
therapeutic uses. Specific inhibitors of
melatonin synthesis are not yet
Bisubstrate Inhibitors of
available and serotonin antagonists have
Acetyltransferases
unacceptable side effects in many
Dr. David Klein et al. (NICHD).
patients.
HHS Reference No. E–205–1999/0–
In addition to licensing, the
PCT–02 filed 08 Aug 2000.
technology is available for further
Licensing Contact: Marlene Shinn-Astor; development through collaborative
301/435–4426; shinnm@mail.nih.gov. research opportunities with the
The present invention provides
inventors.
methods of inhibiting acetyletransferase
Imaging With Positron-Emitting
enzymes, such as arylalkylamine-NTaxanes, Camptothecins, and Other
acetyltransferase (AANAT), by
Drugs as a Guide to Antitumor Therapy
producing a bisubstrate inhibitor in a
cell. AANAT catalyzes the transfer of
Jerry M. Collins, Raymond W. Klecker,
acetyl groups from Acetyl coenzyme A
Lawrence Anderson (FDA).
(AcCoA) to substrates such as serotonin. U.S. Patent Application No. 10/088,561
filed 19 Mar 2002 (HHS Reference No.
Bisubstrate inhibitors are compounds
E–263–1998/0–US–03);
which share characteristics of AcCoA
U.S. Patent Application No. 10/319,812
and of the specific acetyl group
filed 16 Dec 2002 (HHS Reference No.
acceptors. A highly potent bisubstrate
E–263–1998/1–US–01).
inhibitor of AANAT is CoA-S-Nacetyltryptamine. That inhibitor may be Licensing Contact: Michael Shmilovich;
301/435–5019;
formed in vitro by the reaction of
shmilovm@mail.nih.gov.
alkylating derivatives of the acetyl
Available for licensing and
acceptor and AcCoA. However, the
inhibitor thus formed does not cross the commercial development is a method
for using of positron-emitting
cell membranes and is expensive to
compounds to label taxane type drugs.
produce using AcCoA.
The present invention is based on the This invention also relates to the use,
synthesis and structure of three radiosurprising discovery that a bisubstrate
labeled probe molecules, 11C–SN–38,
inhibitor which is specific for a
11C-imatinib, and 11C-mitoxantrone.
particular acetyltransferase can be
formed in a cell by introducing into the
SN–38 is a major active metabolite of
cell an alkylating derivative of an acetyl Camptosar, a product marketed by
acceptor. Formation of the bisubstrate
Pharmacia for the treatment of
inhibitor occurs efficiently at very low
colorectal cancer. Imatinib is a
concentrations of introduced drug
compound that is used to treat chronic
because the enzyme to be inhibited
myeloid leukemia (CML) and is
including RT–PCR and multiplex PCR
applications, regardless of the organism/
gene/nucleic acid being targeted. It
provides the user/assay developer a
choice of control product sizes,
fluorogenic probe reporting systems,
and thermal cycling options, allowing
ease of incorporation into various assay
formats and instrument platforms. This
unique internal control also can be
readily incorporated into virtually any
existing quantitative multiplex real-time
PCR assay. The invention also provides
methods of using the internal control
system and kits of the invention.
Additional information may be found
in Vickery et al., ‘‘Detection and
Quantification of Total and Potentially
Virulent Vibrio parahaemolyticus Using
a 4-Channel Multiplex Real-Time PCR
Targeting the tl, tdh, and trh Genes and
a Novel PCR Internal Control,’’
published abstract, 103rd General
Meeting of the American Society for
Microbiology, May 18–23, 2003,
Washington, DC.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
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Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices
marketed under the tradename Gleevec.
Mitoxantrone is also used to treat
certain types of cancers and multiple
sclerosis. For all of these compounds
the FDA approved new and expanded
uses and there is intense interest in
determining whether and where each of
the compounds actually collects in the
body, and especially whether they are
taken up by the targeted tumor.
Traditional approaches to determine
drug uptake and retention have been
invasive. Advantages of using this
technology include: (1) Avoidance of
exposing patients to toxic drugs that
have no potential for benefit; (2) ability
to rapidly determine whether a given
tumor will be likely to respond to a
particular drug; and (3) the ability to
monitor the impact of various dosages,
schedules, and modulators for delivery,
in situ, at the actual tumor under
treatment conditions. Further, methods
to guide treatment of solid tumors, with
labeled taxanes, are also disclosed in the
present application.
Additional information may be found
in: Ravert et al., ‘‘Radiosynthesis of
[11C]paclitaxel,’’ J Label Compd and
Radiopharm, 2002, 45(6):471–477.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Dated: December 1, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–7249 Filed 12–12–05; 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.
AGENCY:
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.
VerDate Aug<31>2005
00:22 Dec 13, 2005
Jkt 208001
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.
ADDRESSES:
Quantitative Assay of the Angiogenic
and Antiangiogenic Activity of a Test
Molecule
Steven K. Libutti (NCI).
U.S. Patent Application No. 11/014,472
filed 16 Dec 2004 (HHS Reference No.
E–152–2002/1–US–01).
Licensing Contact: Mojdeh Bahar; 301–
435–2950; baharm@mail.nih.gov.
The invention provides a method of
measuring the angiogenic or
antiangiogenic activity of a test
molecule. The method comprises
obtaining an embryonated fowl egg,
creating a window in the shell of the
fowl egg, such that the CAM membrane
is exposed, providing to a test region of
interest on the CAM a substrate,
administering to a vessel located in the
CAM a test molecule, administering to
a vessel located in the CAM a
fluorescent-labeled particle, such that
the fluorescent-labeled particle travels
through each vessel contained in the
test region of interest, removing the
substrate and the test region of interest
from the fowl egg, capturing a threedimensional image of the test region of
interest, wherein the three-dimensional
image comprises a plurality of pixels,
such that a fluorescent vascular density
(FVD) value can be assigned to the test
region of interest, and comparing the
FVD value of the test region of interest
with the FVD value of a control region
of interest that was prepared in the same
manner as the test region of interest but
without the administration of a test
molecule, such that the angiogenic or
antiangiogenic activity of the test
molecule is measured. A lower FVD
value of the test region of interest as
compared to the FVD value of the
control region of interest is indicative of
the test molecule being useful as an
inhibitor of angiogenesis. Conversely, a
higher FVD value of the test region of
interest as compared to the FVD value
of the control region of interest is
indicative of the test molecule being
useful as a stimulator of angiogenesis.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
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73781
Autotaxin: Motility Simulating Protein
Useful in Cancer Diagnosis and
Therapy
Mary Stracke, Lance Liotta, Elliot
Schiffman, Jerry Krutzch, and Jun
Murata (NCI).
U.S. Patent Application filed 16 Feb
2005 (HHS Reference No. E–142–
1990–2–US–05).
Licensing Contact: Mojdeh Bahar; 301–
435–2950; baharm@mail.nih.gov.
Cell motility plays an important role
in embryonic events, adult tissue
remodeling, wound healing and
metastasis of tumor cells. Some tumor
cells produce proteins termed
‘‘autocrine motility factors’’ that
stimulate motility in tumor cells. This
invention describes a novel tumor
protein called Autotaxin (‘‘ATX’’) that
stimulates both random and directed
migration of human A2058 melanoma
cells. ATX is a member of the
nucleotide phosphodiesterase and
pyrophosphatase (NPP) family of
proteins but is the only member of the
family that stimulates motility. It is also
the only member shown to possess
lysophospholipase D activity.
This invention can provide a
functional marker that can directly
estimate the invasive potential of a
particular human cancer. One could
also use this invention as an assay for
a particular secreted marker in body
fluids, or in tissues. Other uses include
the detection, diagnosis, and treatment
of human malignancies, and other
inflammatory, fibrotic, infectious and
healing disorders.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Dated: December 1, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–7250 Filed 12–12–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
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]]>Agencies
[Federal Register Volume 70, Number 238 (Tuesday, December 13, 2005)]
[Notices]
[Pages 73779-73781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7249]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications 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.
Tri-Functional Nanospheres
Yun-bo Shi (NICHD) et al.
U.S. Patent Application No. 11/135,380 filed 24 May 2005 (HHS Reference
No. E-145-2005/0-US-01).
Licensing Contact: Cristina Thalhammer-Reyero; 301/435-4507;
thalhamc@mail.nih.gov.
Available for licensing and commercial development is an invention
related to ``biofunctional'' tri-functional nanospheres (TFNs) or
multi-functional nanospheres (MFNs) obtained by binding one or more
biomaterials, such as folate, IgG, biotin or streptavidin, to
fluorescent-magnetic bifunctional nanospheres (BFNs). Unlike other BFNs
available, which are virtually all based on having a magnetic core, the
present invention is based on mesoporous BFNs with hydrophobic inner
cavities. The properties of the TFNs of the subject invention have
superior qualities for use for the various applications that require
aqueous solutions.
Nanospheres are becoming the materials of choice for a rapidly
increasing number of pharmaceutical and biomedical applications,
including the use of quantum dots (QDs) and magnetic nanoparticles.
Materials with the combined function of fluorescent labeling and
magnetic separation have many applications in biomedical science,
including those resulting from the encapsulation of both particles in
polymer microcapsules. However, these related prior technologies are
predominantly dependent on core-shell type technologies. Typically, a
magnetic material such as magnetite or a fluorescent particle such as a
QD is used as a core. Such a core-shell structure is chemically
unstable and disadvantageous for fluorescence applications because the
shell tends to absorb either or both of the excitation and emission
lights, thus dimming the fluorescent signal. The nanoparticles of this
invention are composed of a mesoporous copolymer, a magnetic material
embedded into the mesoporous copolymer, a fluorescent nanomaterial
concurrently embedded into the mesoporous copolymer, and one or more
biomaterials coupled to the mesoporous copolymer.
TFNs and MFNs have multiple uses. When the TFNs are labeled by a
single biomaterial, the nanoparticles may specifically bind to a cell,
or a protein or any other moiety that to which the biomaterial
specifically binds. For instance, the biomaterial may be a small
molecule ligand that is specifically bound by a cell surface receptor.
MFNs in which two bioagents are coupled to single BFNs allow using one
bioagent to target a macromolecule or a cell and using the second one
to alter the function/properties of the macromolecule or cell, e.g.,
using a protein to target a cell and using a toxin or cell death
protein to kill the targeted cell, or using a chemical or protein to
target a protein within a complex and another one to alter the function
of a different component of the complex.
The technology is further described in ``Biofunctionalization of
fluorescent-magnetic-biofunctional nanospheres and their
applications,'' Guo-Ping Wang, Er-Qun Song, Hai-Yan Xie, Zhi-Ling
Zhang, Zhi-Quan Tian, Chao Zuo, Dai-Wen Pang, Dao-Cheng Wu and Yun-Bo
Shi; Chemical Communications, 2005, (34), 4276-4278; DOI: 10.1039/
b508075d.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Efficient Growth of Wild-Type Hepatitis A Virus in Cell Culture for
Development of Live Vaccines
Gerarado Kaplan and Krishnamurthy Konduru (FDA).
[[Page 73780]]
U.S. Provisional Application No. 60/684,526 filed 28 Jun 2005 (HHS
Reference No. E-151-2004/0-US-01).
Licensing Contact: Chekesha S. Clingman; 301/435-5018;
clingmac@mail.nih.gov.
This technology relates to the development of recombinant wild-type
and attenuated Hepatitis A Virus (HAV) vectors capable of growing in
cell culture and useful for development of a live HAV vaccine. This
technology also encompasses HAV vectors coding for markers that allow
the selection of cell lines that support the efficient growth of wild-
type and attenuated HAV in culture for diagnostic and environmental
monitoring purposes. The currently available killed HAV vaccines are
expensive and require a two dose schedule to confer immunity for
approximately two decades. Inability of wild-type (wt) HAV to grow
efficiently in cell culture has been the major roadblock to developing
a live HAV vaccine, which could confer lifelong immunity, be cost-
effective and allow eradication of the virus. The inventors have
developed recombinant infectious HAV coding for resistance genes
against antibiotics that inhibits translation in mammalian cells and
provides a selective phenotype that allows selection of cells
expressing the phenotype within one week. Also, the inventors have
created methods of selecting cells permissive for replication of wild-
type and not overly attenuated HAV by utilizing selective or screened
phenotypes and antibiotic resistant cell techniques.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Internal Control Nucleic Acid Molecule for Real-Time Polymerase Chain
Reaction
Michael Vickery, Angelo DePaola, George Blackstone (FDA).
U.S. Provisional Application No. 60/471,121 filed 16 May 2003 (HHS
Reference No. E-213-2003/0-US-01);
PCT Application No. PCT/US04/15175 filed 14 May 2004 (HHS Reference No.
E-213-2003/0-PCT-02).
Licensing Contact: Michael Shmilovich; 301/435-5019;
shmilovm@mail.nih.gov.
The invention provides a PCR internal control system for use in
both real-time PCR (also known as kinetic or Q-PCR) and conventional
PCR. This flexible system has a number of novel design qualities which
make it universally adaptable for use in virtually any real-time or
conventional PCR assay, including RT-PCR and multiplex PCR
applications, regardless of the organism/gene/nucleic acid being
targeted. It provides the user/assay developer a choice of control
product sizes, fluorogenic probe reporting systems, and thermal cycling
options, allowing ease of incorporation into various assay formats and
instrument platforms. This unique internal control also can be readily
incorporated into virtually any existing quantitative multiplex real-
time PCR assay. The invention also provides methods of using the
internal control system and kits of the invention.
Additional information may be found in Vickery et al., ``Detection
and Quantification of Total and Potentially Virulent Vibrio
parahaemolyticus Using a 4-Channel Multiplex Real-Time PCR Targeting
the tl, tdh, and trh Genes and a Novel PCR Internal Control,''
published abstract, 103rd General Meeting of the American Society for
Microbiology, May 18-23, 2003, Washington, DC.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Bisubstrate Inhibitors of Acetyltransferases
Dr. David Klein et al. (NICHD).
HHS Reference No. E-205-1999/0-PCT-02 filed 08 Aug 2000.
Licensing Contact: Marlene Shinn-Astor; 301/435-4426;
shinnm@mail.nih.gov.
The present invention provides methods of inhibiting
acetyletransferase enzymes, such as arylalkylamine-N-acetyltransferase
(AANAT), by producing a bisubstrate inhibitor in a cell. AANAT
catalyzes the transfer of acetyl groups from Acetyl coenzyme A (AcCoA)
to substrates such as serotonin. Bisubstrate inhibitors are compounds
which share characteristics of AcCoA and of the specific acetyl group
acceptors. A highly potent bisubstrate inhibitor of AANAT is CoA-S-N-
acetyltryptamine. That inhibitor may be formed in vitro by the reaction
of alkylating derivatives of the acetyl acceptor and AcCoA. However,
the inhibitor thus formed does not cross the cell membranes and is
expensive to produce using AcCoA.
The present invention is based on the surprising discovery that a
bisubstrate inhibitor which is specific for a particular
acetyltransferase can be formed in a cell by introducing into the cell
an alkylating derivative of an acetyl acceptor. Formation of the
bisubstrate inhibitor occurs efficiently at very low concentrations of
introduced drug because the enzyme to be inhibited positions and
catalyzes the reactants favorably to form the inhibitor. The
bisubstrate inhibitor is likely to accumulate in the cell because it is
stable, highly charged and thus will not pass through cell membranes.
The targeted acetyltransferase will thus be inhibited and therapeutic
actions realized.
The varied actions of acetyltransferases in biochemical processes
offer many potential therapeutic targets. Acetylation inactivates drugs
and endogenous ligands so inhibitors could, for example, enhance the
effectiveness of antibiotics where antibiotic resistance is due to a
high level of acetylation. In the case of AANAT, acetylation
inactivates serotonin and is the rate limiting step in the formation of
melatonin. Inhibition of AANAT will thus decrease melatonin production
and increase serotonin levels. Melatonin is a pineal hormone that has
endocrinological, neurophysiological, and behavioral functions. Since
melatonin and serotonin are implicated in several types of mood
disorders, inhibition of AANAT could have valuable therapeutic uses.
Specific inhibitors of melatonin synthesis are not yet available and
serotonin antagonists have unacceptable side effects in many patients.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Imaging With Positron-Emitting Taxanes, Camptothecins, and Other Drugs
as a Guide to Antitumor Therapy
Jerry M. Collins, Raymond W. Klecker, Lawrence Anderson (FDA).
U.S. Patent Application No. 10/088,561 filed 19 Mar 2002 (HHS Reference
No. E-263-1998/0-US-03);
U.S. Patent Application No. 10/319,812 filed 16 Dec 2002 (HHS Reference
No. E-263-1998/1-US-01).
Licensing Contact: Michael Shmilovich; 301/435-5019;
shmilovm@mail.nih.gov.
Available for licensing and commercial development is a method for
using of positron-emitting compounds to label taxane type drugs. This
invention also relates to the use, synthesis and structure of three
radio-labeled probe molecules, \11\C-SN-38, \11\C-imatinib, and \11\C-
mitoxantrone. SN-38 is a major active metabolite of Camptosar, a
product marketed by Pharmacia for the treatment of colorectal cancer.
Imatinib is a compound that is used to treat chronic myeloid leukemia
(CML) and is
[[Page 73781]]
marketed under the tradename Gleevec. Mitoxantrone is also used to
treat certain types of cancers and multiple sclerosis. For all of these
compounds the FDA approved new and expanded uses and there is intense
interest in determining whether and where each of the compounds
actually collects in the body, and especially whether they are taken up
by the targeted tumor. Traditional approaches to determine drug uptake
and retention have been invasive. Advantages of using this technology
include: (1) Avoidance of exposing patients to toxic drugs that have no
potential for benefit; (2) ability to rapidly determine whether a given
tumor will be likely to respond to a particular drug; and (3) the
ability to monitor the impact of various dosages, schedules, and
modulators for delivery, in situ, at the actual tumor under treatment
conditions. Further, methods to guide treatment of solid tumors, with
labeled taxanes, are also disclosed in the present application.
Additional information may be found in: Ravert et al.,
``Radiosynthesis of [11C]paclitaxel,'' J Label Compd and Radiopharm,
2002, 45(6):471-477.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Dated: December 1, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E5-7249 Filed 12-12-05; 8:45 am]
BILLING CODE 4140-01-P
