E6-19051. 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.

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: [e-mail]; telephone: [phone]; facsimile: [phone].

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-α, IFN-γ, 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.