[Federal Register Volume 69, Number 163 (Tuesday, August 24, 2004)]
[Notices]
[Pages 52019-52020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: (301) 496-7057; fax: (301) 402-0220. A 
signed Confidential Disclosure Agreement will

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be required to receive copies of the patent applications.

Methods of Use of Nitrite Therapy

    M. Gladwin (CC), R. Cannon (NHLBI), A. Schechter (NIDDK), C. Hunter 
(CC), R. Pluta (NINDS), E. Oldfield (NINDS), D. Kim-Shapiro (EM), R. 
Patel (EM), D. Lefer (EM), G. Power (EM). U.S. Patent Application 60/
484,959 filed 09 July 2003 (DHHS Reference No. E-254-2003/0-US-01). 
U.S. Patent Application 60/511,244 filed 14 Oct 2003 (DHHS Reference 
No. E-254-2003/1-US-01). PCT Applications filed 09 July 2004 (DHHS 
Reference Nos. E-254-2003/2-PCT-01 and E-254-2003/3-PCT-01).
    Licensing Contact: Susan Carson; (301) 435-5020; 
[email protected].
    Different therapeutic classes of compounds that are able to 
increase blood flow and act as vasodilators have been used to treat a 
wide variety of disease indications including cardiovascular and 
respiratory diseases. Endothelium-derived factors, such as nitric oxide 
(NO), play a crucial role in the maintenance of vascular homeostasis, 
and NO-enhancing compounds have been administered alone or in 
combination with an approved pharmaceutical agent in order to provide 
an effective therapeutic treatment. Many of these therapies are very 
costly and there remains a strong need for an affordable treatment. 
Recent scientific work by the inventors provided evidence that the 
anion nitrite represents a circulating and tissue storage form of 
nitric oxide whose bioactivation is mediated by the nitrite reductase 
activity of deoxyhemoglobin [Nature Medicine 2003 9(12):1498-1505].
    NIH scientists and their collaborators have now shown that low, 
physiological and non-toxic concentrations of sodium nitrite are able 
to increase blood flow and produce vasodilation by infused and 
nebulised routes of administration. Proof of concept data has been 
obtained in animal models for myocardial and hepatic ischemia and 
reperfusion injury, in a neonate lamb model for neonatal pulmonary 
hypertension, and in a primate model for prevention of delayed cerebral 
vasospasm following sub-arachnoid hemorrhage. 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 tissue hypoxia. 
Available for licensing are method of use claims for nitrite salt 
formulations directed to conditions associated with high blood 
pressure, decreased blood flow or hemolytic disease (E-254-2003/2) and 
for the treatment of specific conditions such as pulmonary 
hypertension, cerebral artery vasospasm and hepatic, cardiac or brain 
ischemia-reperfusion injury (E-254-2003/3).

    Dated: August 14, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-19301 Filed 8-23-04; 8:45 am]
BILLING CODE 4140-01-P