[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Notices]
[Page 66182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Field of Use: Treatment 
of Inflammatory Diseases Using Ghrelin

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, is contemplating the grant of 
an exclusive license to practice the invention embodied in:
    U.S. Provisional Patent application, S/N 60/569,819 filed May 11, 
2004, entitled ``Methods for Inhibiting Proinflammatory Cytokine 
Expression Using Ghrelin,'' converted to PCT on May 11, 2005 (E-016-
2004/0-PCT-02), (Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric 
Schaffer, and Dzung Nguyen) (NIA), to Sapphire Therapeutics, Inc. 
(Hereafter Sapphire), having a place of business in Bridgewater of NJ. 
The patent rights in these inventions have been assigned to the United 
States of America.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
January 12, 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: Sally Hu, PhD, M.B.A., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; e-mail: [email protected]; telephone: 
(301) 435-5606; facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: 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.
    E-016-2004/0-US-01 provides methods for treating inflammation by 
inhibiting pro-inflammatory cytokine expression using Ghrelin, or a 
fragment thereof. Inflammation could be caused by a variety of viral, 
bacterial, fungal, or parasitic infections. The invention also provides 
methods for treating loss of appetite, and sepsis. Ghrelin, a naturally 
occurring peptide hormone was shown to be the ligand for growth hormone 
secretagogue receptor (GHS-R ), and is mainly produced by the 
epithelial cells in the stomach. Ghrelin exerts many important actions 
in the body, including stimulation of growth hormone secretion, 
induction of appetite, and regulation of energy expenditure. Ghrelin 
directly controls human growth hormone and insulin growth factor 
expression by human immune cells. The inventors showed that Ghrelin 
exerts anti-inflammatory effects by inhibiting the secretion of acute 
and chronic cytokines, including IL-1, IL-6, TNF-[alpha], IFN-[gamma], 
IL-12, chemokines, and CSF in vitro and in in vivo mouse models of 
sepsis and inflammation. This invention can be useful for treatment of 
various inflammatory disorders, including inflammatory bowel disease, 
Crohn's disease, rheumatoid arthritis, multiple sclerosis, 
atherosclerosis, endotoxemia, and graft-versus-host disease. It can 
also be used as a treatment for loss of appetite and sepsis.
    The field of use may be limited to the use of Ghrelin as a novel 
drug to treat a range of inflammatory diseases.
    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 30, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-19051 Filed 11-9-06; 8:45 am]
BILLING CODE 4140-01-P