[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77418-77419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8139]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of 
Cardiovascular Conditions With Nitrite Therapy

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This 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 Hope Medical Enterprises, Inc., dba Hope 
PharmaceuticalsTM, an Arizona S-Corporation having a 
principle place of business in Scottsdale, Arizona. The field of use 
may be limited to the use of nitrite salts for the treatment of 
cerebral vasospasm following subarachnoid hemorrhage and/or 
cardiovascular 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 
February 28, 2006 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: [email protected]; 
Telephone: (301) 435-5020; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: A wide variety of disease indications, 
including cardiovascular and respiratory diseases, have been treated by 
different therapeutic classes of compounds that are able to increase 
blood flow and act as vasodilators. 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. Proof 
of concept data has been obtained in animal models for (1) myocardial 
and hepatic ischemia and reperfusion injury [J. Clin. Invest. (2005) 
115, 1232-1240], (2) neonatal pulmonary hypertension in a neonate lamb 
model [Nature Medicine (2004) 10, 1122-1127] and (3) control of delayed 
cerebral vasospasm following subarachnoid hemorrhage in a primate model 
[JAMA (2005) 293, 1477-1484]. The implications of these results point 
to the use of nitrite as a potential cost-effective platform therapy 
for a wide variety of disease indications characterized broadly by 
constricted blood flow or hypoxia. Method of use claims for nitrite 
salt formulations are directed to conditions associated with high blood 
pressure, decreased blood flow or hemolytic disease and for the 
treatment of specific conditions such as pulmonary hypertension, 
cerebral artery vasospasm and hepatic, cardiac or brain ischemia-
reperfusion injury.

[[Page 77419]]

    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: December 22, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E5-8139 Filed 12-29-05; 8:45 am]
BILLING CODE 4140-01-P