Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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 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; carsonsu@mail.nih.gov.

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).