National Heart, Lung, and Blood Institute (NHLBI); Opportunity for a Cooperative Research and Development Agreement (CRADA) to Identify and Explore Epigenetic Regulatory Elements for Diagnostic and Therapeutics Purposes, 3715-3716 [05-1412]
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Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
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default.htm.
Dated: January 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1394 Filed 1–25–05; 8:45 am]
BILLING CODE 4160–01–S
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for diagnostic and therapeutic purposes.
The role of the CRADA collaborator(s)
will include, but not be limited to, the
National Institutes of Health
following:
1. The ability to collaborate with
National Heart, Lung, and Blood
NHLBI on further research and
Institute (NHLBI); Opportunity for a
development of this technology. This
Cooperative Research and
ability can be demonstrated through
Development Agreement (CRADA) to
experience and expertise in this or
Identify and Explore Epigenetic
related areas of technology indicating
Regulatory Elements for Diagnostic
the ability to contribute intellectually to
and Therapeutics Purposes
on-going research and development.
2. To assist with obtaining specimen/
AGENCY: National Institutes of Health,
tissues (patient and normal controls) for
Public Health Service, HHS.
the Genome-Wide analysis as diagnostic
ACTION: Notice.
and therapeutic markers.
3. To assist to further developing the
SUMMARY: The National Heart, Lung, and
epigenetic regulatory elements markers/
Blood Institute (NHLBI) is seeking
acetylation islands as new targets for
Cooperative Research and Development
novel drug-development strategies.
Agreement (CRADA) collaborator(s) to
The collaborator may also be expected
work with investigators in the
to contribute financial support under
Laboratory of Molecular Immunology
this CRADA for personnel, supplies,
(LMI) to identify epigenetic regulatory
travel, and equipment to support these
elements that may be involved in the
projects. The collaborator is also
disease development of T and/or B cell
expected to cooperate with the NHLBI
leukemia/lymphoma and other cancers
in the timely publication of research
via genome-wide analysis of acetylation results and to accept the legal
islands using the Genome-Wide
provisions and language of the CRADA
Mapping Technique (GMAT).
with only minor modifcations, if any.
Representative disease-specific
DATES: CRADA capability statements
acetylation islands will be explored for
should be submitted to Vincent
diagnostic and therapeutic purposes.
Kolesnitchenko, Ph.D., Technology
SUPPLEMENTARY INFORMATION:
Transfer Specialist, National Heart,
Epigenetics play a critical role in
Lung, and Blood Institute (NHLBI),
cellular development and cellular
Office of Technology Transfer and
transformation in many pathogenic
Development, National Institutes of
processes. For example, many cancers
Health, 6705 Rockledge Drive, Suite
are correlated with changes of their
6018, MSC 7992, Bethesda, MD 20892–
chromatin structure and are sensitive to 7992; Phone: (301) 594–4115; Fax: (301)
drugs that modulate the levels of
594–3080; E-mail: vk5q@nih.gov.
histone acetylation. Epigenetic
Capability statements must be received
regulation refers to the modification of
on or before March 28, 2005.
chromatin including posttranslational
The NHLBI has applied for patents
modification of histones, which does
claiming the core of the technology.
not involve change of DNA sequences of Non-exclusive and/or exclusive licenses
target genes. MHLBI investigators have
for these patents covering core aspects
mapped the genome-wide distribution
of this project are available to interested
of histone H3 acetylation in human T
parties.
cells and discovered over 40,000
Licensing inquiries regarding this
acetylation islands using a technique
technology should be addressed to John
called GMAT. This tool combines
Stansberry, Ph.D., Technology Licensing
Chromatin immunoprecipitation (Chip)
Specialist, Office of Technology
of hyper-acetylated histones, with Serial Transfer, National Institutes of Health,
Analysis of Gene Expression (SAGE).
6011 Executive Boulevard, Suite 325,
The acetylation islands are epigenetic
Rockville, Maryland 20852–3804,
markers for transcriptional regulatory
Phone: (301) 435–5236; Fax: (301) 402–
elements and chromatin controlling
0220; E-mail: stansbej@od.nih.gov.
elements. Changes of the acetylation
Information about Patent Applications
islands may be correlated with early
and pertinent information not yet
development of T cell lymphoma or
publicly described an be obtained under
leukemia. Therefore, this discovery may the terms of a Confidential Disclosure
be applied to early diagnosis and/or
Agreement.
Respondents interested in submitting
treatment of these diseases.
The NHLBI is seeking capability
a CRADA Proposal should be aware that
statements from parties interested in
it may be necessary to secure a license
entering into a CRADA to identify,
to the above-mentioned patent rights in
explore and further develop epigenetic
order to commercialize products arising
regulatory elements/acetylation islands
from a CRADA.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Federal Register / Vol. 70, No. 16 / Wednesday, January 26, 2005 / Notices
Dated: January 14, 2005.
Dr. Carl Roth,
Associate Director for Scientific Program
Operations, National Heart, Lung, and Blood
Institute.
[FR Doc. 05–1412 Filed 1–25–05; 8:45 am]
BILLING CODE 4140–01–M
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.
Treatment of Inappropriate Immune
Responses
Drs. He Xu and Allan D. Kirk (NIDDK)
U.S. Provisional Patent Application
filed Jun 18, 2004 (DHHS Reference
No. E–102–2004/0–US–01)
Licensing Contact: Marlene ShinnAstor; 301/435–4426;
shinnm@mail.nih.gov.
Activated human leukocytes play an
essential role in counter-adaptive
immune responses such as allograft
rejection, autoimmune disease, and
graft-versus-host disease. Depletion of
leukocytes involved in these responses
by using preparations of leukocytesspecific antibodies may be therapeutic
in preventing and reversing these
conditions. To date, however, the
available monoclonal preparations do
not have sufficiently broad specificity to
limit the activity of many types of cells
involved in counter-adaptive immunity,
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and the available polyclonal
preparations have significant side
effects caused by their unintended
specificity for bystander cells or cells
with beneficial properties.
The NIH announces a new treatment
for blocking an undesirable immune
response, wherein polyclonal antibodies
are designed to preferentially target
activated immune cells, rather than
resting immune cells or blood cells
involved in non-immune processes.
These antibodies have a heightened
specificity for activated lymphocytes
and monocytes and decreased activity
for resting or beneficial leukocytes and
other blood elements.
A Novel Nuclear Receptor Cofactor
Modulates Glucocorticoid-Responsive
Gene Expression
S. Stoney Simons and Yuanzheng He
(NIDDK);
U.S. Patent Application No. 60/548, 039
filed 26 Feb 2004 (DHHS Reference
No. E–056–2004/0–US–01);
Licensing Contact: Susan Carson, (301)
435–5020; carsonsu@mail.nih.gov.
Nuclear receptors are ligand-activated
transcription factors that regulate a wide
range of biological processes and
dysfunction of these receptors can lead
to proliferative, reproductive and
metabolic diseases, such as cancer,
infertility, obesity and diabetes. Nuclear
receptors are the second largest class of
drug targets and the market for nuclear
receptor targeted drugs is estimated to
be almost 15% of the $400 billion global
pharmaceutical market. Researchers at
the National Institute of Diabetes and
Digestive and Kidney Disease have
isolated a novel protein termed STAMP
(SRC–1 and TIF–2 Associated
Modulatory Protein) that interacts with
the biologically active domains of the
coactivators TIF–2 and SRC–1 (J. Biol.
Chem. (2002) 51, 49256–66) and present
data which support a role for STAMP as
an important new factor in the
glucocorticoid regulatory network.
There remains a need for novel
therapeutics that specifically block or
enhance specific genes and an emerging
therapeutic goal is the discovery of
agents that modulate co-activators or corepressors in a tissue specific manner.
The invention is a novel protein that
plays a key role in modulating
transcriptional properties of
glucocorticoid receptor (GR)-steroid
complexes during both gene induction
and gene repression, and is likely to
modulate the transcriptional properties
of all the steroid receptors including
androgen, mineralocorticoid and
progesterone receptors. The inventors
have shown that ectopically expressed
STAMP protein both modulates the
PO 00000
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EC50 of glucocorticoid receptor-agonist
complexes for induced genes and
increases glucocorticoid receptorrepressive activity of suppressed genes
in a manner that is inhibited by specific
siRNAs under physiologically relevant
conditions. The modulation of STAMP
levels at the cell or organism level could
possibly be used as a therapeutic able to
modify inappropriate gene expression
that occurs in certain diseases or as a
result of long-term steroid treatment.
Available for licensing are claims
directed to compositions which are
capable of modulating the GR gene
expression in a mammalian cell using
DNA, siRNA or antibodies and to
methods of shifting a steroid doseresponse curve, where less of the steroid
needs to be administered because the
composition contains the STAMP
polypeptide. The novel STAMP
functional sequence can be used in a
composition of matter claim or as a
target that could be regulated by an
antibody or perhaps other modulator
that would vary the ability of STAMP to
either induce or repress the activity of
glucocorticoid receptors. Diseases that
could be treated include: hypertension,
diabetes, cardiovascular disease,
osteoporosis, Cushing’s Disease as well
as any disease requiring chronic steroid
treatment such as Rheumatoid Arthritis,
Asthma, inflammatory and autoimmune diseases. The present invention
provides a broad, flexible IP platform
that should be of interest to companies
which focus on nuclear receptors as
drug target and lead discovery
generators, as well as to companies
which have the capability to develop
STAMP’s potential as a therapeutic.
In addition to licensing, the
technology is available for further
development through collaborative
research with the inventors via a
Cooperative Research and Development
Agreement (CRADA).
Generation of Smad3-Null Mice and
Smad4-Conditional Mice
Chuxia Deng (NIDDK);
DHHS Reference Nos. E–349–2003/0
and E–350–2003/0—Research Tools;
Licensing Contact: Marlene ShinnAstor; (301) 435–4426;
shinnm@mail.nih.gov.
SMADs are a novel set of mammalian
proteins that act downstream of TGFbeta family ligands. These proteins can
be categorized into three distinct
functional sets, receptor-activated
SMADs (SMADs 1, 2, 3, 5, and 8), the
common mediator SMAD (SMAD 4),
and inhibitory SMADs (SMADs 6 and
7). SMAD proteins are thought to play
a role in vertebrate development and
tumorigenesis.
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]]>Agencies
[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3715-3716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1412]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute (NHLBI); Opportunity
for a Cooperative Research and Development Agreement (CRADA) to
Identify and Explore Epigenetic Regulatory Elements for Diagnostic and
Therapeutics Purposes
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung, and Blood Institute (NHLBI) is
seeking Cooperative Research and Development Agreement (CRADA)
collaborator(s) to work with investigators in the Laboratory of
Molecular Immunology (LMI) to identify epigenetic regulatory elements
that may be involved in the disease development of T and/or B cell
leukemia/lymphoma and other cancers via genome-wide analysis of
acetylation islands using the Genome-Wide Mapping Technique (GMAT).
Representative disease-specific acetylation islands will be explored
for diagnostic and therapeutic purposes.
SUPPLEMENTARY INFORMATION: Epigenetics play a critical role in cellular
development and cellular transformation in many pathogenic processes.
For example, many cancers are correlated with changes of their
chromatin structure and are sensitive to drugs that modulate the levels
of histone acetylation. Epigenetic regulation refers to the
modification of chromatin including posttranslational modification of
histones, which does not involve change of DNA sequences of target
genes. MHLBI investigators have mapped the genome-wide distribution of
histone H3 acetylation in human T cells and discovered over 40,000
acetylation islands using a technique called GMAT. This tool combines
Chromatin immunoprecipitation (Chip) of hyper-acetylated histones, with
Serial Analysis of Gene Expression (SAGE). The acetylation islands are
epigenetic markers for transcriptional regulatory elements and
chromatin controlling elements. Changes of the acetylation islands may
be correlated with early development of T cell lymphoma or leukemia.
Therefore, this discovery may be applied to early diagnosis and/or
treatment of these diseases.
The NHLBI is seeking capability statements from parties interested
in entering into a CRADA to identify, explore and further develop
epigenetic regulatory elements/acetylation islands for diagnostic and
therapeutic purposes. The role of the CRADA collaborator(s) will
include, but not be limited to, the following:
1. The ability to collaborate with NHLBI on further research and
development of this technology. This ability can be demonstrated
through experience and expertise in this or related areas of technology
indicating the ability to contribute intellectually to on-going
research and development.
2. To assist with obtaining specimen/tissues (patient and normal
controls) for the Genome-Wide analysis as diagnostic and therapeutic
markers.
3. To assist to further developing the epigenetic regulatory
elements markers/acetylation islands as new targets for novel drug-
development strategies.
The collaborator may also be expected to contribute financial
support under this CRADA for personnel, supplies, travel, and equipment
to support these projects. The collaborator is also expected to
cooperate with the NHLBI in the timely publication of research results
and to accept the legal provisions and language of the CRADA with only
minor modifcations, if any.
DATES: CRADA capability statements should be submitted to Vincent
Kolesnitchenko, Ph.D., Technology Transfer Specialist, National Heart,
Lung, and Blood Institute (NHLBI), Office of Technology Transfer and
Development, National Institutes of Health, 6705 Rockledge Drive, Suite
6018, MSC 7992, Bethesda, MD 20892-7992; Phone: (301) 594-4115; Fax:
(301) 594-3080; E-mail: vk5q@nih.gov. Capability statements must be
received on or before March 28, 2005.
The NHLBI has applied for patents claiming the core of the
technology. Non-exclusive and/or exclusive licenses for these patents
covering core aspects of this project are available to interested
parties.
Licensing inquiries regarding this technology should be addressed
to John Stansberry, Ph.D., Technology Licensing Specialist, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, Maryland 20852-3804, Phone: (301) 435-
5236; Fax: (301) 402-0220; E-mail: stansbej@od.nih.gov. Information
about Patent Applications and pertinent information not yet publicly
described an be obtained under the terms of a Confidential Disclosure
Agreement.
Respondents interested in submitting a CRADA Proposal should be
aware that it may be necessary to secure a license to the above-
mentioned patent rights in order to commercialize products arising from
a CRADA.
[[Page 3716]]
Dated: January 14, 2005.
Dr. Carl Roth,
Associate Director for Scientific Program Operations, National Heart,
Lung, and Blood Institute.
[FR Doc. 05-1412 Filed 1-25-05; 8:45 am]
BILLING CODE 4140-01-M
