[Federal Register Volume 72, Number 200 (Wednesday, October 17, 2007)]
[Notices]
[Page 58864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of 
Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor

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. 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 application PCT/US2004/041265 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 Emiliem, Inc., a Delaware Corporation, having a place of business in 
Emeryville, California. The field of use may be limited to the use of 
2-(4-piperazinyl) substituted 4H-1-benzopyran-4-one compounds, 
including 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), 
for the treatment of cancer and/or other proliferative disorders not 
currently licensed, excluding the treatment and prevention of stenosis 
and restenosis. 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 
December 17, 2007 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; Email: [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 PI3K 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 suggest that (2-(4-
piperazinyl)-8-phenyl-4H-1-benzopyran-4-one and derivatives may be 
effective in treating inflammatory, autoimmune and other proliferative 
disorders including restenosis, inflammatory bowel disease 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: October 10, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-20516 Filed 10-16-07; 8:45 am]
BILLING CODE 4140-01-P