National Institute of General Medical Sciences; Notice of Closed Meeting, 63843 [2010-26185]
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Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
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encompassed by this technology are
more potent and/or more specific TSH
receptor activators than currentlyavailable compounds; also, as small
molecules, these compounds are orally
available and are expected to be less
costly and more straightforward to
produce than recombinant protein
counterparts currently on the market.
According to the National Cancer
Institute, over 37,000 new cases of
thyroid cancer were diagnosed in the
United States in 2008, and over 1,500
people died of this disease. These
numbers reflect a progressive increase
in the incidence of thyroid cancer over
the last several years. Because most
cases of thyroid cancer are diagnosed in
patients between the ages of 20 and 54,
these patients will undergo decades of
follow-up monitoring after cancer
treatment. For the last decade,
recombinant TSH protein has been used
in this follow-up to increase detection
sensitivity for recurrent or metastatic
thyroid cancer, and to eliminate side
effects associated with withdrawal of
hormone replacement therapy. A smallmolecule TSH receptor agonist
encompassed by this technology would
have utility similar to recombinant TSH,
but would have several distinct
advantages. For example, as a small
molecule, rather than a recombinant
protein, such a compound would be
orally available, and would be less
difficult and expensive to produce.
These compounds are also more potent
and/or specific for the TSH receptor
than other known small-molecule TSH
receptor agonists. In addition to use in
thyroid cancer screening, these
compounds may also be useful for
adjunctive treatment (with radioactive
iodide) of thyroid cancer, and certain
forms of hypothyroidism.
Hyperthyroidism, or an overactive
thyroid gland, affects about 1% of
people in the United States and is often
caused by autoimmune over-stimulation
of the thyroid gland (Graves’ disease), or
by thyroid tumors. Drugs currently used
for treatment of hyperthyroidism inhibit
synthesis of thyroid hormones; the TSH
receptor antagonist compounds
encompassed by this technology have
the advantage of directly inhibiting
activity of the TSH receptor, rather than
inhibiting thyroid hormone synthesis.
Applications
• Diagnostic tools for evaluation and
treatment of thyroid cancer.
• Therapeutics for thyroid cancer,
hyperthyroidism, and hypothyroidism.
Market: Approximately 1 in 13
Americans suffers from a thyroid
disorder, and 10 million have a thyroid-
VerDate Mar<15>2010
16:45 Oct 15, 2010
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related condition that requires ongoing
immunodiagnostic monitoring.
Development Status: Early stage.
Inventors: Marvin C. Gershengorn et
al. (NIDDK)
Publications
1. Moore S, Jaeschke H, Kleinau G,
Neumann S, Costanzi S, Jiang JK,
Childress J, Raaka BM, Colson A,
Paschke R, Krause G, Thomas CJ,
Gershengorn MC. Evaluation of smallmolecule modulators of the luteinizing
hormone/choriogonadotropin and
thyroid stimulating hormone receptors:
structure-activity relationships and
selective binding patterns. J Med Chem.
2006 Jun 29;49(13):3888–3896.
[PubMed: 16789744]
2. Neumann S, Kleinau G, Costanzi S,
Moore S, Raaka BM, Thomas CJ, Krause
G, Gershengorn MC. A low molecular
weight antagonist for the human
thyrotropin receptor with therapeutic
potential for hyperthyroidism.
Endocrinology 2008 Dec;149(12):5945–
5950. [PubMed: 18669595]
3. Unpublished data are also available
for review under a CDA.
Patent Status
HHS Reference Nos. E–223–2006/0
and E–223–2006/1—
• International Patent Application
No. PCT/US2007/011951 filed 17 May
2007, which published as WO 2007/
136776 on 29 Nov 2007
• National Phase entered in Australia,
Canada, Europe, Japan, and the United
States
HHS Reference No. E–284–2008/0—
• International Patent Application
No. PCT/US2008/011958 filed 20 Oct
2008.
Licensing Status: Available for
licensing.
Licensing Contact: Tara L. Kirby, PhD;
301–435–4426; tarak@mail.nih.gov.
Collaborative Research Opportunity:
The NIDDK Clinical Endocrinology
Branch is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize small molecule TSH
receptor modulators. Please contact
Marguerite J. Miller at 301–496–9003 or
millermarg@mail.nih.gov for more
information.
63843
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Minority Biomedical
Research Neuro Grant Applications.
Date: November 12, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency-Bethesda, 7400
Wisconsin Avenue, One Bethesda Metro
Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18J, Bethesda,
MD 20892, 301–594–2773,
laffanjo@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: October 12, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26185 Filed 10–15–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
National Institutes of Health
[FR Doc. 2010–26160 Filed 10–15–10; 8:45 am]
Notice is hereby given of a change in
the meeting of the National Institute of
BILLING CODE 4140–01–P
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National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
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[Federal Register Volume 75, Number 200 (Monday, October 18, 2010)]
[Notices]
[Page 63843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26185]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of General Medical
Sciences Special Emphasis Panel; Review of Minority Biomedical
Research Neuro Grant Applications.
Date: November 12, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency-Bethesda, 7400 Wisconsin Avenue, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Institute of General
Medical Sciences, National Institutes of Health, Natcher Building,
Room 3AN18J, Bethesda, MD 20892, 301-594-2773,
laffanjo@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.375,
Minority Biomedical Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology, Physiology, and
Biological Chemistry Research; 93.862, Genetics and Developmental
Biology Research; 93.88, Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National Institutes of Health, HHS)
Dated: October 12, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-26185 Filed 10-15-10; 8:45 am]
BILLING CODE 4140-01-P
