Government-Owned Inventions; Availability for Licensing, 45252-45253 [E7-15749]
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
these requirements, a standard
Investigational Drug Accountability
Report Form (NIH 2564) was designed
to account for drug inventories and
usage by protocols. The data obtained
from the drug accountability record will
be used to keep track of the dispensing
of investigational anticancer agents to
patients. It is used by NCI management
to ensure that investigational drug
supplies are not diverted for
inappropriate protocol or patient use.
The information is also compared to
patient flow sheets (protocol reporting
forms) during site visits conducted for
each investigator once every three years.
All comparisons are done with the
intention of ensuring protocol, patient
and drug compliance for patient and
drug compliance for patient safety and
protections.
Frequency of Response: Daily.
Affected Public: State or local
governments, businesses or other forprofit. Federal agencies or employees,
non-profit institutions, and small
business or organizations.
Type of Respondents: Investigators,
pharmacist, nurses, pharmacy
technicians, data manager. The annual
reporting burden is divided into two
major areas. These are the audits of Drug
Accountability Forms by Government
and its contractors and the use of the
forms by clinical research sites. The
burden is as follows:
Federal Burden: 1,700 audits are
conducted of clinical research sites, a
minimum of three Drug Accountability
Forms are reviewed at the audit. Each
form requires a 1⁄2 hour to review.
Number of Respondents: 1,700.
Number of Responses per
Respondent: 3.
Average Burden per Response: 0.5
hours.
Annual Burden Hours: 2,250 hours.
Clinical Trial Site Burden: The
annualized respondents’ burden for
recordkeeping is estimated to require
6,240 hours. The recordkeeping burden
represents an average time required for
multiple entries (4 minutes or 0.1 hour
per entry) on the drug accountability
form, the average number of forms
maintained by each recordkeeper and
the number of recordkeepers.
Drug Accountability Forms
Number of Record Keepers: 3,990.
Number of Responses per
Respondent: 16.
Average Burden per Response: 0.1.
Annual Burden Hours: 6,240 hours.
There are no Capital Costs, Operating
Costs, and Maintenance Cost to report.
Request for Comments
Written comments and/or suggestions
from the public and affected agencies
VerDate Aug<31>2005
16:19 Aug 10, 2007
Jkt 211001
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information;
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Charles L. Hall, Jr.,
Chief, Pharmaceutical Management
Branch, Cancer Therapy Evaluation
Program, Division of the Cancer
Treatment and Diagnosis, and Centers,
National Cancer Institute, Executive
Plaza North, Room 7148, 9000 Rockville
Pike, Bethesda, MD 20892 or call nontoll-free number 301–496–5725 or email your request, including your
address to: Hallch@mail.nih.gov.
Due Date: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days following the date of this
publication.
Dated: August 3, 2007.
Ann E. Duane,
Acting NCI Project Clearance Liaison,
National Institutes of Health.
[FR Doc. E7–15750 Filed 8–10–07; 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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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.
An Improved Chromosomal
Comparative Genomic Hybridization
(CGH) Microarray for the Detection of
Cancer Associated Genome
Amplification and Deletion Events
Description of Technology: The
progression and therapeutic response of
cancer is closely associated with
chromosomal instability (i.e. genomic
amplifications and deletions). The most
widely used technique to detect these
small changes in the genome is CGH.
CGH utilizes nucleic acid hybridization
to oligonucleotide features
corresponding to specific,
predetermined regions of the genome to
detect DNA copy number changes. Due
to the size of the human genome, it is
necessary to have high-density features
to detect small amplification and
deletion events within the genome.
The current invention is based on a
CGH microarray with oligonucleotide
features that provides a high-density
coverage. More specifically, the
inventors have used 60-mer
oligonucleotide features within a
previously shown set of 36 tumor
associated genes/genomic regions and
have successfully detected small
changes in DNA copy number with high
density coverage (1 feature per 400bp).
Furthermore, the inventors have used a
fade-out design for coverage of the
flanking regions and cover the
remainder of the genome at an average
density of 1 feature per 100kb.
Applications:
1. CGH microarray can be used to
detect small regions of genomic
instability within cancer associated
genes, while larger events can also be
detected with similar efficacy.
2. Gene amplification and deletion
profiles of patient samples can be used
in diagnosis and therapeutic decision
making.
Advantages:
1. Easy to use, CGH microarray
technique, based on current technology.
2. Technology detects small changes
in tumor associated genomic instability
E:\FR\FM\13AUN1.SGM
13AUN1
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
more efficiently than current available
technologies.
3. The average coverage of Agilent
oligoarray is 1 per 35kb of human
genome, while the average coverage of
the currently described technology is 1
per 400bp.
Developmental Status: The
technology is ready for use.
Benefits: More than 600,000 cancer
deaths are estimated to occur in 2007.
Efficient diagnosis and informed
decision making will aid in improved
clinical management of cancer. This
technology can rapidly diagnose cancer
and thus help in proper clinical
management leading to improved
overall survival and quality of life of
patients suffering from cancer. The
current in-vitro diagnostics market is
valued at $30 billion dollars and
expected to grow.
Inventors: Xiaolin Wu, David Munroe,
Ester Rozenblum, Hongling Liao (NCI/
SAIC).
Patent Status: U.S. Provisional
Application No. 60/911,411 filed 12
April 2007 (HHS Reference No. E–122–
2007/0–US–01).
Licensing Contact: Thomas P. Clouse,
J.D.; 301/435–4076;
clouset@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute
Laboratory of Molecular Technology is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
CGH microarrays. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Methods and Compositions for Treating
Diseases and Disorders Associated with
Natural Killer T–Cells
Description of Technology: The
invention relates to the discovery that
C12 beta-D-galactosyl ceramide may be
used to deplete or inactivate NKT cell
populations. These findings suggest
methods for using C12 beta-D-galactosyl
ceramide to treat conditions that would
benefit from depletion of NKT cells,
such as certain autoimmune diseases
(e.g. lupus, MS) and AIDS.
The presence of NKT cells can be
associated with either beneficial effects
or pathology. Deficiencies in NKT cells
are associated with at least some types
of autoimmune disease, including type
1 diabetes and autoimmune gastritis in
mice. In contrast, NKT cells augment
autoantibody secretion and lupus
development in lupus-prone mouse
models and therefore lupus patients
may benefit from the depletion of NKT
cells. The remission state of multiple
VerDate Aug<31>2005
16:19 Aug 10, 2007
Jkt 211001
sclerosis (MS) is also associated with
decreased levels of NKT cells,
suggesting NKT cell depletion as a
method of treatment for MS.
Inventors: John R. Ortaldo and Robert
H. Wiltrout (NCI).
Patent Status:
U.S. Provisional Application No. 60/
488,339 filed 17 July 2003 (HHS
Reference No. E–282–2002/0–US–01).
PCT Application No. PCT/US2004/
22913 filed 16 Jul 2004, which
published as WO 2005/014008 on 17
Feb 2005 (HHS Reference No. E–282–
2002/0–PCT–02).
European Application No. 04778424.4
filed 16 Jul 2004, which published as
1653977 on 10 May 2006 (HHS
Reference No. E–282–2002/0–EP–03).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301/435–4633; wongje@mail.nih.gov.
P53 and VGEF Regulate Tumor Growth
of NO2 Expressing Cancer Cells
Description of Technology: The
increased expression of nitric oxide
synthase 2 (NOS2), an inducible enzyme
that produces nitric oxide (NO), has
been found in a variety of human
cancers. It also has been shown that
NOS2-specific inhibitors can reduce the
growth of experimental tumors in mice.
These findings suggest a
pathophysiological role for NO in the
development and progression of cancer.
However, the function of NO and NOS2
in carcinogenesis is uncertain. NO had
been found to either inhibit or stimulate
tumor growth, and high concentrations
of NO also are known to induce cell
death in many cell types including
tumor cells. On the other hand, the
lower concentrations of NO that are
found in human tissue can have an
opposite effect and protect against
programmed cell death, or apoptosis,
from various stimuli. The role of NO
and NOS2 in tumor progression,
particularly with respect to p53,
therefore need to be further defined.
This invention comprises methods of
screening for modulators of NOS2
expression in p53 mutant cells, both in
vivo and in vitro, as well as methods for
predicting the chemotherapeutic benefit
of administering NOS2-inhibitors to
cancer patients. It has been
demonstrated that NOS2-expressing
cancer cells with wild-type p53 have
reduced tumor growth in athymic nude
mice whereas NOS2-expressing cancer
cells with mutated p53 have accelerated
tumor growth. Therefore, this invention
has potential application for a number
of cancers that overexpress NOS2 and
have a high frequency of p53 mutations,
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
45253
including breast, brain, head, neck, lung
and colon cancers.
Applications:
1. Method to treat cancer with NOS2
inhibitors.
2. Method to screen for NOS2
modulators.
3. Method to predict therapeutic
benefits of NOS2 inhibitors in patients.
Market:
1. An estimated 1,444,920 new cancer
diagnoses in the U.S. in 2007.
2. 600,000 deaths caused by cancer in
the U.S. in 2006.
3. Cancer is the second leading cause
of death in United States.
4. It is estimated that market for
cancer drugs would double to $50
billion a year in 2010 from $25 billion
in 2006.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Stefan Ambs and Curt
Harris (NCI).
Publications:
1. JE Goodman et al. Nitric oxide and
p53 in cancer-prone chronic
inflammation and oxyradical overload
diseases. Environ Mol Mutagen.
2004;44(1):3–9.
2. LJ Hofseth et al. Nitric oxide in
cancer and chemoprevention. Free
Radic Biol Med. 2003Apr 15;34(8):955–
968.
Patent Status:
U.S. Patent Application No. 11/
195,006 filed 01 Aug 2005 (HHS
Reference No. E–223–1998/0–US–04).
U.S. Patent Application No. 09/
830,977 filed 02 May 2001 (HHS
Reference No. E–223–1998/0–US–03).
PCT Patent Application No. PCT/
US1999/27410 filed 17 Nov 1998 (HHS
Reference No. E–223–1998/0–PCT–02).
U.S. Provisional Patent Application
No. 60/109,563 filed 23 Nov 1998 (HHS
Reference No. E–223–1998/0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301/435–4633; wongje@mail.nih.gov.
Dated: August 3, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–15749 Filed 8–10–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Notices]
[Pages 45252-45253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15749]
-----------------------------------------------------------------------
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.
An Improved Chromosomal Comparative Genomic Hybridization (CGH)
Microarray for the Detection of Cancer Associated Genome Amplification
and Deletion Events
Description of Technology: The progression and therapeutic response
of cancer is closely associated with chromosomal instability (i.e.
genomic amplifications and deletions). The most widely used technique
to detect these small changes in the genome is CGH. CGH utilizes
nucleic acid hybridization to oligonucleotide features corresponding to
specific, predetermined regions of the genome to detect DNA copy number
changes. Due to the size of the human genome, it is necessary to have
high-density features to detect small amplification and deletion events
within the genome.
The current invention is based on a CGH microarray with
oligonucleotide features that provides a high-density coverage. More
specifically, the inventors have used 60-mer oligonucleotide features
within a previously shown set of 36 tumor associated genes/genomic
regions and have successfully detected small changes in DNA copy number
with high density coverage (1 feature per 400bp). Furthermore, the
inventors have used a fade-out design for coverage of the flanking
regions and cover the remainder of the genome at an average density of
1 feature per 100kb.
Applications:
1. CGH microarray can be used to detect small regions of genomic
instability within cancer associated genes, while larger events can
also be detected with similar efficacy.
2. Gene amplification and deletion profiles of patient samples can
be used in diagnosis and therapeutic decision making.
Advantages:
1. Easy to use, CGH microarray technique, based on current
technology.
2. Technology detects small changes in tumor associated genomic
instability
[[Page 45253]]
more efficiently than current available technologies.
3. The average coverage of Agilent oligoarray is 1 per 35kb of
human genome, while the average coverage of the currently described
technology is 1 per 400bp.
Developmental Status: The technology is ready for use.
Benefits: More than 600,000 cancer deaths are estimated to occur in
2007. Efficient diagnosis and informed decision making will aid in
improved clinical management of cancer. This technology can rapidly
diagnose cancer and thus help in proper clinical management leading to
improved overall survival and quality of life of patients suffering
from cancer. The current in-vitro diagnostics market is valued at $30
billion dollars and expected to grow.
Inventors: Xiaolin Wu, David Munroe, Ester Rozenblum, Hongling Liao
(NCI/SAIC).
Patent Status: U.S. Provisional Application No. 60/911,411 filed 12
April 2007 (HHS Reference No. E-122-2007/0-US-01).
Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076;
clouset@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Laboratory of Molecular Technology is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize CGH microarrays. Please
contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Methods and Compositions for Treating Diseases and Disorders Associated
with Natural Killer T-Cells
Description of Technology: The invention relates to the discovery
that C12 beta-D-galactosyl ceramide may be used to deplete or
inactivate NKT cell populations. These findings suggest methods for
using C12 beta-D-galactosyl ceramide to treat conditions that would
benefit from depletion of NKT cells, such as certain autoimmune
diseases (e.g. lupus, MS) and AIDS.
The presence of NKT cells can be associated with either beneficial
effects or pathology. Deficiencies in NKT cells are associated with at
least some types of autoimmune disease, including type 1 diabetes and
autoimmune gastritis in mice. In contrast, NKT cells augment
autoantibody secretion and lupus development in lupus-prone mouse
models and therefore lupus patients may benefit from the depletion of
NKT cells. The remission state of multiple sclerosis (MS) is also
associated with decreased levels of NKT cells, suggesting NKT cell
depletion as a method of treatment for MS.
Inventors: John R. Ortaldo and Robert H. Wiltrout (NCI).
Patent Status:
U.S. Provisional Application No. 60/488,339 filed 17 July 2003 (HHS
Reference No. E-282-2002/0-US-01).
PCT Application No. PCT/US2004/22913 filed 16 Jul 2004, which
published as WO 2005/014008 on 17 Feb 2005 (HHS Reference No. E-282-
2002/0-PCT-02).
European Application No. 04778424.4 filed 16 Jul 2004, which
published as 1653977 on 10 May 2006 (HHS Reference No. E-282-2002/0-EP-
03).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jennifer Wong; 301/435-4633;
wongje@mail.nih.gov.
P53 and VGEF Regulate Tumor Growth of NO2 Expressing Cancer Cells
Description of Technology: The increased expression of nitric oxide
synthase 2 (NOS2), an inducible enzyme that produces nitric oxide (NO),
has been found in a variety of human cancers. It also has been shown
that NOS2-specific inhibitors can reduce the growth of experimental
tumors in mice. These findings suggest a pathophysiological role for NO
in the development and progression of cancer. However, the function of
NO and NOS2 in carcinogenesis is uncertain. NO had been found to either
inhibit or stimulate tumor growth, and high concentrations of NO also
are known to induce cell death in many cell types including tumor
cells. On the other hand, the lower concentrations of NO that are found
in human tissue can have an opposite effect and protect against
programmed cell death, or apoptosis, from various stimuli. The role of
NO and NOS2 in tumor progression, particularly with respect to p53,
therefore need to be further defined.
This invention comprises methods of screening for modulators of
NOS2 expression in p53 mutant cells, both in vivo and in vitro, as well
as methods for predicting the chemotherapeutic benefit of administering
NOS2-inhibitors to cancer patients. It has been demonstrated that NOS2-
expressing cancer cells with wild-type p53 have reduced tumor growth in
athymic nude mice whereas NOS2-expressing cancer cells with mutated p53
have accelerated tumor growth. Therefore, this invention has potential
application for a number of cancers that overexpress NOS2 and have a
high frequency of p53 mutations, including breast, brain, head, neck,
lung and colon cancers.
Applications:
1. Method to treat cancer with NOS2 inhibitors.
2. Method to screen for NOS2 modulators.
3. Method to predict therapeutic benefits of NOS2 inhibitors in
patients.
Market:
1. An estimated 1,444,920 new cancer diagnoses in the U.S. in 2007.
2. 600,000 deaths caused by cancer in the U.S. in 2006.
3. Cancer is the second leading cause of death in United States.
4. It is estimated that market for cancer drugs would double to $50
billion a year in 2010 from $25 billion in 2006.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Stefan Ambs and Curt Harris (NCI).
Publications:
1. JE Goodman et al. Nitric oxide and p53 in cancer-prone chronic
inflammation and oxyradical overload diseases. Environ Mol Mutagen.
2004;44(1):3-9.
2. LJ Hofseth et al. Nitric oxide in cancer and chemoprevention.
Free Radic Biol Med. 2003Apr 15;34(8):955-968.
Patent Status:
U.S. Patent Application No. 11/195,006 filed 01 Aug 2005 (HHS
Reference No. E-223-1998/0-US-04).
U.S. Patent Application No. 09/830,977 filed 02 May 2001 (HHS
Reference No. E-223-1998/0-US-03).
PCT Patent Application No. PCT/US1999/27410 filed 17 Nov 1998 (HHS
Reference No. E-223-1998/0-PCT-02).
U.S. Provisional Patent Application No. 60/109,563 filed 23 Nov
1998 (HHS Reference No. E-223-1998/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jennifer Wong; 301/435-4633;
wongje@mail.nih.gov.
Dated: August 3, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-15749 Filed 8-10-07; 8:45 am]
BILLING CODE 4140-01-P
