Prospective Grant of Exclusive License: Use of Inhaled Nitrite Therapy for the Treatment of Pulmonary Conditions, 4284 [E7-1378]
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Federal Register / Vol. 72, No. 19 / Tuesday, January 30, 2007 / Notices
93.393–93.396, 93.837–93.844, 93.846–
93.878, 93.892, 93.893, National
Institutes of Health, HHS).
Dated: January 18, 2007.
David Clary,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–368 Filed 1–29–07; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Use of Inhaled Nitrite Therapy
for the Treatment of Pulmonary
Conditions
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
ycherry on PROD1PC64 with NOTICES
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services (HHS), is
contemplating the grant of an exclusive
license to practice the invention
embodied in: PCT patent applications
PCT/US2004/21985 and PCT/US2004/
22232, filed July 9, 2004, both entitled
‘‘Use of Nitrite Salts for the Treatment
of Cardiovascular Conditions’’ [HHS
Reference Number: E–254–2003/2–3–
PCT–01], to Aires Pharmaceuticals, Inc.,
a portfolio company of ProQuest
Investments LLC, Princeton, N.J. The
field of use of inhaled administration of
nitrite salts for this exclusive license
may be limited to the use of inhaled
formulations of nitrite salts for the
treatment of Pulmonary Hypertension
and pulmonary and/or cardiopulmonary
conditions. The United States of
America is an assignee of the patent
rights in these inventions.
DATES: Only written comments and/or
application for a license, which are
received by the NIH Office of
Technology Transfer on or before April
2, 2007 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Susan Carson, D.Phil., Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
E-mail: carsonsu@od.nih.gov;
Telephone: (301) 435–5020; Facsimile:
(301) 402–0220.
SUPPLEMENTARY INFORMATION: The core
invention is the unexpected finding that
VerDate Aug<31>2005
15:36 Jan 29, 2007
Jkt 211001
low, physiological and non-toxic
concentrations of sodium nitrite are able
to increase blood flow and produce
vasodilation by infused and nebulized
routes of administration. Pulmonary
Hypertension (PH) occurs as a primary
or idiopathic disease as well as
secondary to a number of pulmonary
and systemic diseases, such as neonatal
PH and sickle cell disease. There is no
cure for pulmonary hypertension, a
nitric-oxide deficient state characterized
by pulmonary vasoconstriction and
systemic hypoxemia and therapies vary
in efficacy and cost. Recent studies by
NIH researchers and their collaborators
provided evidence that the blood anion
nitrite contributes to hypoxic
vasodilation through a heme-based,
nitric oxide (NO)-generating reaction
with deoxyhemoglobin and potentially
other heme proteins [Nature Medicine
2003 9: 1498–1505]. These initial results
indicate that sodium nitrite can be used
as a potential cost-effective platform
therapy for a wide variety of disease
indications characterized broadly by
constricted blood flow or hypoxia.
These results have been further
corroborated by work in the neonatal
lamb model for PH. Inhaled sodium
nitrite delivered by aerosol to newborn
lambs with hypoxic pulmonary
hypertension elicited a rapid and
sustained reduction (65%) in hypoxiainduced pulmonary hypertension.
Pulmonary vasodilation elicited by
aerosolized nitrite was
deoxyhemoglobin- and pH-dependent
and was associated with increased
blood levels of iron-nitrosylhemoglobin. Notably, short term
delivery of nitrite dissolved in saline
through nebulization produced
selective, sustained pulmonary
vasodilation with no clinically
significant increase in blood
methemoglobin levels. [Nature
Medicine 2004 10: 1122–1127]. Method
of use claims for nitrite salt
formulations are directed to conditions
associated with high blood pressure,
decreased blood flow and for the
treatment of specific conditions such as
pulmonary hypertension and other
indications.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 60 days from the date of this
published Notice, NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications
for a license filed in response to this
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: January 22, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–1378 Filed 1–29–07; 8:45 am]
BILLING CODE 4140–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive
License: Prevention and Treatment of
Human Cancer and Tumors by
Inhibitors of Any or All of the
Adenosine Receptor Subtypes
Covered by the Licensed Patent Rights
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of a coexclusive license to practice the
invention embodied in Patent
Applications U.S. 60/340,772, filed on
12/12/2001, U.S. 60/342,582, filed on
12/19/2001, PCT/US2002/036829, filed
on 11/14/2002, and corresponding EP,
CA, AU, and JP filings, as well as U.S.
10/498,416, filed on 06/10/2004;
entitled ‘‘Methods for using
extracellular adenosine inhibitors and
adenosine receptor inhibitors to
enhance immune response and
inflammation’’, all by Michail V.
Sitkovsky, and Akio Ohta, to Redox
Therapies, Inc., having a place of
business in Boston, MA. The patent
rights in this invention have been
assigned to the United States of
America.
DATES: Only written comments and/or
application for a license that are
received by the NIH Office of
Technology Transfer on or before April
2, 2007 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Cristina Thalhammer-Reyero, Ph.D.,
M.B.A., Office of Technology Transfer,
E:\FR\FM\30JAN1.SGM
30JAN1
Agencies
[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Page 4284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1378]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Use of Inhaled Nitrite
Therapy for the Treatment of Pulmonary Conditions
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH),
Department of Health and Human Services (HHS), is contemplating the
grant of an exclusive license to practice the invention embodied in:
PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed
July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of
Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT-
01], to Aires Pharmaceuticals, Inc., a portfolio company of ProQuest
Investments LLC, Princeton, N.J. The field of use of inhaled
administration of nitrite salts for this exclusive license may be
limited to the use of inhaled formulations of nitrite salts for the
treatment of Pulmonary Hypertension and pulmonary and/or
cardiopulmonary conditions. The United States of America is an assignee
of the patent rights in these inventions.
DATES: Only written comments and/or application for a license, which
are received by the NIH Office of Technology Transfer on or before
April 2, 2007 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Susan Carson, D.Phil., Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; E-mail: carsonsu@od.nih.gov;
Telephone: (301) 435-5020; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: The core invention is the unexpected finding
that low, physiological and non-toxic concentrations of sodium nitrite
are able to increase blood flow and produce vasodilation by infused and
nebulized routes of administration. Pulmonary Hypertension (PH) occurs
as a primary or idiopathic disease as well as secondary to a number of
pulmonary and systemic diseases, such as neonatal PH and sickle cell
disease. There is no cure for pulmonary hypertension, a nitric-oxide
deficient state characterized by pulmonary vasoconstriction and
systemic hypoxemia and therapies vary in efficacy and cost. Recent
studies by NIH researchers and their collaborators provided evidence
that the blood anion nitrite contributes to hypoxic vasodilation
through a heme-based, nitric oxide (NO)-generating reaction with
deoxyhemoglobin and potentially other heme proteins [Nature Medicine
2003 9: 1498-1505]. These initial results indicate that sodium nitrite
can be used as a potential cost-effective platform therapy for a wide
variety of disease indications characterized broadly by constricted
blood flow or hypoxia.
These results have been further corroborated by work in the
neonatal lamb model for PH. Inhaled sodium nitrite delivered by aerosol
to newborn lambs with hypoxic pulmonary hypertension elicited a rapid
and sustained reduction (65%) in hypoxia-induced pulmonary
hypertension. Pulmonary vasodilation elicited by aerosolized nitrite
was deoxyhemoglobin- and pH-dependent and was associated with increased
blood levels of iron-nitrosyl-hemoglobin. Notably, short term delivery
of nitrite dissolved in saline through nebulization produced selective,
sustained pulmonary vasodilation with no clinically significant
increase in blood methemoglobin levels. [Nature Medicine 2004 10: 1122-
1127]. Method of use claims for nitrite salt formulations are directed
to conditions associated with high blood pressure, decreased blood flow
and for the treatment of specific conditions such as pulmonary
hypertension and other indications.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless, within 60 days
from the date of this published Notice, NIH receives written evidence
and argument that establishes that the grant of the license would not
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response to
this notice will not be made available for public inspection, and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: January 22, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-1378 Filed 1-29-07; 8:45 am]
BILLING CODE 4140-04-P