Center for Scientific Review; Notice of Closed Meeting, 53888 [2018-23266]
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53888
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
Most mortality occurs in the developing
world where clinical care is less
accessible. Mortality is low in the
developed countries, but the morbidity
is substantial: In the United States
alone, RSV is associated with an
estimated 132,000–172,000
hospitalizations annually in children
less than 5 years old. There is not yet
available a vaccine or an effective
antiviral drug suitable for routine use.
This invention relates to a broadly
antiviral small chemical molecule,
Rostafuroxin, expected to be well
tolerated in humans and available for
clinical evaluation. In particular, this
patent application relates to the novel
and unexpected finding that
Rostafuroxin substantially inhibits RSV
infection.
ATP1A1 is a host protein involved
with cellular entry of RSV. RSV entry
was found to require activation of a
signaling cascade mediated by ATP1A1
which resembles the signaling pathway
(also mediated by ATP1A1) triggered by
cardiotonic steroids.
Though not evaluated for RSV,
ATPA1A was previously implicated as
a pro-viral factor in the infection cycles
of a number of viruses, but the nature
of its involvement and mechanism of
action were unknown.
Rostafuroxin, a synthetic
digitoxigenin derivative, is a smallmolecule that is known to specifically
bind ATP1A1. It has not been
previously known to have any antiviral
activity.
The inventors have evidence that
Rostafuroxin inhibits RSV infection in
respiratory epithelial cells. Rostafuroxin
inhibits RSV induced ATP1A1mediated signaling pathway required for
RSV entry. This was demonstrated in
A549 cells, a widely used human
respiratory epithelial cell line, and in
primary human airway epithelial cells
derived from a healthy human.
Rostafuroxin has been previously
tested in clinical studies as an antihypertensive agent. It has no adverse
effects in healthy humans and,
importantly, does not lower the normal
systolic blood pressure of healthy
individuals.
Rostafuroxin is a promising anti-viral
drug candidate for RSV and possibly
other viruses that use the same pathway
for host cell entry.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Viral therapeutics
VerDate Sep<11>2014
18:10 Oct 24, 2018
Jkt 247001
• Viral diagnostics
• Vaccine research
Competitive Advantages:
• Ease of manufacture
• Broad antiviral activity
• Favorable safety profile in clinical
trials
Development Stage:
• In vivo data assessment (animal)
Inventors: Shirin Munir (NIAID),
Matthias Lingemann (NIAID), Peter
Collins (NIAID).
Intellectual Property: HHS Reference
No. E–202–2018–0—U.S. Provisional
Application No. 62/737,899, filed
September 27, 2018 (pending).
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize for development of a
vaccine for respiratory or other
infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov.
Dated: October 15, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–23312 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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: Chronic Disease and Epidemiology.
Date: October 24, 2018.
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Dated: October 18, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–23266 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–B–1855]
Changes in Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice lists communities
where the addition or modification of
Base Flood Elevations (BFEs), base flood
depths, Special Flood Hazard Area
(SFHA) boundaries or zone
designations, or the regulatory floodway
(hereinafter referred to as flood hazard
determinations), as shown on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports,
prepared by the Federal Emergency
Management Agency (FEMA) for each
community, is appropriate because of
new scientific or technical data. The
FIRM, and where applicable, portions of
the FIS report, have been revised to
reflect these flood hazard
determinations through issuance of a
Letter of Map Revision (LOMR), in
accordance with Federal Regulations.
The LOMR will be used by insurance
agents and others to calculate
appropriate flood insurance premium
rates for new buildings and the contents
SUMMARY:
Center for Scientific Review; Notice of
Closed Meeting
PO 00000
Time: 1:00 p.m. to 3:00 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: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.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. 93.306, 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)
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[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Page 53888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23266]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, 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: Chronic Disease and Epidemiology.
Date: October 24, 2018.
Time: 1:00 p.m. to 3:00 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: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, 301-435-0684, [email protected].
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. 93.306,
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 18, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-23266 Filed 10-24-18; 8:45 am]
BILLING CODE 4140-01-P
