National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings, 72814-72815 [2016-25473]
Download as PDF
72814
Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
and Skin Diseases Clinical Trials Review
Committee.
Date: October 25–26, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Kathy Salaita, SCD,
Scientific Review Officer, Scientific Review
Branch, National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Blvd., Building One, Room
818, Bethesda, MD 20892, 301–594–5033,
kathy.salaita@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; NIAMS
Institutional Training Grants (T32) Review
Meeting.
Date: October 28, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: 6701 Democracy Boulevard,
Building One, Conference Room 807,
Bethesda, MD 20892.
Contact Person: Yin Liu, Ph.D., MD,
Scientific Review Officer, Scientific Review
Branch, National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Blvd., Building One, Room
824, Bethesda, MD 20892, 301–594–8919,
liuy@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: October 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–25472 Filed 10–20–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Notice of Availability of License;
Mutant IHD1 Inhibitors Useful for
Treating Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention Mutant IHD1
Inhibitors Useful for Treating Cancer is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development in the
U.S.
SUMMARY:
VerDate Sep<11>2014
19:06 Oct 20, 2016
Jkt 241001
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn: Sury Vepa,
Ph.D., J.D., Senior Licensing and
Patenting Manager, National Center for
Advancing Translational Sciences, NIH,
9800 Medical Center Drive, Rockville,
MD 20850, Phone: 301–217–9197, Fax:
301–217–5736, or email
NCATSPartnerships@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: This
notice is made in accordance with 35
U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development.
Intellectual Property
Description of Technology: Isocitrate
dehydrogenase 1 (IDH1) is an enzyme
whose normal function is to convert
isocitrate to a-ketoglutarate. Mutated
forms of this enzyme (mIDH1) are
common in a variety of cancers
including acute myeloid leukemia
(AML), glioma, cholangiocarcinoma,
chondrosarcoma and melanoma. The
IDH1 mutation at position 132 and
similar IDH1 mutations result in the
enzyme gaining the ability to catalyze
the NADPH-dependent reduction of the
wild type enzyme’s product, aketoglutarate to R–2-hydroxyglutarate
(2–HG). 2–HG is an oncometabolite, and
its elevated levels have been shown to
lead to de-differentiation of cells.
Mutant IDH1 is an attractive target for
anti-cancer therapeutics as inhibition
reduces levels of 2–HG. It is expected
that lower 2–HG levels will result in
fewer undifferentiated cancer cells.
Furthermore, inhibition of mutant IDH1
is expected to have little effect on noncancerous cells, as these cells do not
express the IDH1 mutation resulting in
lower toxicity than typical cytotoxic
anticancer agents.
In collaboration with the University of
North Carolina, the National Center for
Advancing Translational Sciences
(NCATS) investigators have discovered
a series of novel compounds that
potently and selectively inhibit mIDH1.
These compounds reduce 2–HG levels
in cell lines in vitro as well as in human
cancer cells grown in mouse xenografts
in vivo. These compounds show greater
than 250-fold selectivity for the mutant
enzyme over the wild-type, show
favorable in vitro stability (in mouse,
rat, dog and human hepatocyte exposure
studies), are AMES negative, and exhibit
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
no significant metabolic CYP liabilities.
These compounds possess very
favorable in vivo rodent
pharmacokinetics and bioavailability
and are well tolerated in rodents, even
when dosed at high levels.
Potential Commercial Applications
• Potential treatment of cancer (AML
or other solid tumors listed above).
• Potential treatment of rare diseases
including Maffucci Syndrome and
Ollier Disease.
Value Proposition
• Novel mutant IDH1 inhibitors are
effective at lowering the oncometabolite,
2–HG in in vivo mouse proof-of-concept
studies and are well suited for IND
enabling studies.
Development Stage: Pre-clinical (in
vivo validation).
Inventor(s): Matt Boxer, Kyle
Brimacombe, Mindy Davis, Rajan
Pragani, Jason Rohde, Li Liu, Surendra
Karavadhi, Daniel Urban, Min Shen,
Anton Simeonov, Ajit Jadhav (NCATS)
Xiaodong Wang and Andrew McIver
(Univ. of North Carolina at Chapel Hill)
Intellectual Property:
1. International Application No. PCT/
US15/067406 filed on 12/22/2015
which is entitled ‘‘Mutant IDH1
Inhibitors Useful for Treating Cancer’’
(HHS Ref. No: E–243–2014/0–PCT–02),
and
2. U.S. Provisional Application No.
62/353298 filed on 06/22/2016 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No. E–
189–2016/0–US–01).
Dated: October 5, 2016.
Pamela McInnes,
Deputy Director, Office of the Director,
National Center for Advancing Translational
Sciences.
[FR Doc. 2016–25468 Filed 10–20–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meetings
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 meetings.
The meetings 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
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
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
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; Ancillary
Studies Review Meeting.
Date: November 9, 2016.
Time: 9:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Xincheng Zheng, MD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of
Arthritis, Musculoskeletal and Skin Diseases,
NIH, 6701 Democracy Boulevard, Suite 820,
Bethesda, MD 20892, 301–451–4838,
xincheng.zheng@nih.gov.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; AMS
Member Conflict Meeting.
Date: November 9, 2016.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Kan Ma, Ph.D., Scientific
Review Officer, Scientific Review Branch,
National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Boulevard, Suite 814,
Bethesda, MD 20892, 301–451–4838,mak2@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: October 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–25473 Filed 10–20–16; 8:45 am]
BILLING CODE 4140–01–P
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
Child Health and Human Development
Special Emphasis Panel; Physical Activity
and Leukocyte Activation: Harnessing the
Molecular Pathways of Exercise Adaptation.
Date: November 28, 2016.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6710B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Rita Anand, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, National Institute of Child
Health And Human Development, NIH,
6710B Rockledge Drive, Room 2131C,
Bethesda, MD 20892, 301–496–1487,
anandr@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: December 7, 2016.
Time: 11:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge 6700, 6700B Rockledge Drive,
Bethesda, MD 20817 (Telephone Conference
Call).
Contact Person: Carla T. Walls, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, National Institute of Child
Health and Human Development, NIH, 6710B
Rockledge Drive, Room 2131C, Bethesda, MD
20892, (301) 435–6898, wallsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 17, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–25474 Filed 10–20–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
National Institutes of Health
BILLING CODE 4140–01–P
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
19:06 Oct 20, 2016
Jkt 241001
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Autism, Epilepsy, other
Neurological Disorders.
Date: November 8, 2016.
Time: 11:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246, edwardss@
csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–25470 Filed 10–20–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2016–0937]
Lower Mississippi River Waterway
Safety Advisory Committee
Coast Guard, Department of
Homeland Security.
ACTION: Notice of Federal advisory
committee meeting.
AGENCY:
The Lower Mississippi River
Waterway Safety Advisory Committee
will meet on November 8, 2016 in New
Orleans, LA to discuss committee
matters relating to the safe transit of
vessels and cargoes to and from the
ports of the Lower Mississippi River.
The meeting will be open to the public.
DATES: The Lower Mississippi River
Waterway Safety Advisory Committee
SUMMARY:
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 meetings.
The meetings will be closed to the
public in accordance with the
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
72815
E:\FR\FM\21OCN1.SGM
21OCN1
Agencies
[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72814-72815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases; Notice of Closed Meetings
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
meetings.
The meetings 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
[[Page 72815]]
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 Arthritis and
Musculoskeletal and Skin Diseases Special Emphasis Panel; Ancillary
Studies Review Meeting.
Date: November 9, 2016.
Time: 9:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications
Place: National Institutes of Health, One Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Xincheng Zheng, MD, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard,
Suite 820, Bethesda, MD 20892, 301-451-4838, xincheng.zheng@nih.gov.
Name of Committee: National Institute of Arthritis and
Musculoskeletal and Skin Diseases Special Emphasis Panel; AMS Member
Conflict Meeting.
Date: November 9, 2016.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Kan Ma, Ph.D., Scientific Review Officer,
Scientific Review Branch, National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH, 6701 Democracy Boulevard,
Suite 814, Bethesda, MD 20892, 301-451-4838,mak2@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.846,
Arthritis, Musculoskeletal and Skin Diseases Research, National
Institutes of Health, HHS)
Dated: October 17, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-25473 Filed 10-20-16; 8:45 am]
BILLING CODE 4140-01-P