[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Page 46496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6880]


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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.

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SUMMARY: This is notice, in accordance with 35 U.S.C. Sec.  209(c)(1) 
and 37 CFR Sec.  (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 application PCT/US2004/041256 filed December 9, 2004, 
entitled: ``Methods for Suppressing an Immune Response or Treating a 
Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], 
to Sahajanand Medical Technologies Pvt. Ltd., registered as a private 
limited company in accordance with the Companies Act of India, having a 
principle place of business in Surat, India and U.S. headquarters in 
Gaithersburg, Maryland. The field of use may be limited to the use of 
2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the 
treatment and prevention of stenosis and restenois and/or other 
proliferative disorders. 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 
October 13, 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: The search for specific kinase inhibitors is 
an active area of drug development as there is a continued need for 
effective anti-proliferative therapeutics with acceptable toxicities. 
The core invention is a novel method of use of one of the 4H-1-
benzopyran-4-one derivatives (LY303511) which has been shown to target 
mTOR and casein kinase 2 (CK2) without affecting P13K activity (JPET, 
May 26, 2005, doi: 10.1124/jpet.105.083550). Proof of concept data is 
available in an in vivo human zenograft PC-3 prostate tumor model, 
without observed toxicity. In vitro data suggests that (2-(4-
piperazinyl)-8-pheynl-4H-1 benzopyran-4-one and derivatives may be 
effective in treating inflammatory, autoimmune and other proliferative 
disorders including restenosis and a variety of cancers. Method of use 
claims are directed to derivatives of 2-(4-piperazinyl)-substituted 4H-
1-benzopyran-4-one compounds as anti-proliferative, immunosuppressive, 
anti-inflammatory, anti-restenosis and anti-neoplastic agents.
    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: July 24, 2006
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 06-6880 Filed 8-11-06; 8:45am]
BILLING CODE 4140-01-M