E5-8139. 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 Pharmaceuticals^TM, 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: [e-mail]; Telephone: [phone]; Facsimile: [phone].

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.

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.