E7-8892. Prospective Grant of Exclusive License: Treatment of Inflammatory Bowel Disease (IBD) Using IL-13 Modulators and Inhibitors

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 (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in:

PCT patent application PCT/US2002/018790 filed 14 June 2002, entitled: “Methods of Treating and Preventing Colitis involving IL-13 and NK-T Cells” [HHS Reference Number: E-131-2002/0-PCT-01], to

Wyeth Pharmaceuticals, based in Madison, New Jersey. The field of use may be limited to the use of IL-13 modulators or NK-T cell modulators (such as antibodies) for the treatment or prevention of Inflammatory Bowel Disease, including ulcerative colitis and Crohn's disease. 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 July 9, 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; E-mail: [e-mail]; Telephone: [phone]; Facsimile: [phone].

SUPPLEMENTARY INFORMATION:

Ulcerative colitis (UC) is a chronic inflammatory disease of the colorectum and affects approximately 400,000 people in the United States. The cause of UC is not known, although an abnormal immunological response by the mucosal T cells responsive to bacterial antigens in the gut microflora, is thought to be involved. Present treatments for UC include anti-inflammatory therapy using aminosalicylates or corticosteroids, as well as immunomodulators and diet. However, 25-40% of ulcerative colitis patients must eventually have their colons removed due to massive bleeding, severe illness, rupture of the colon, risk of cancer or due to side effects of corticosteroids and novel treatments are still actively being sought. NIH scientists and their collaborators have used a mouse model of experimental colitis (oxazolone colitis, OC) to show that IL-13, a Th2 cytokine, is a significant pathologic factor in OC and that neutralizing IL-13 in these animals effectively prevents colitis (Immunity (2002) 17, 629-638).

OC is a colitis induced by intrarectal administration of a relatively low dose of the haptenating agent oxazolone subsequent to skin sensitization with oxazolone. A highly reproducible and chronic colonic inflammation is obtained that is histologically similar to human ulcerative colitis. Studies show that NKT cells rather than conventional CD4+T cells mediate oxazolone colitis and that NKT cells are the source of IL-13, and are activated by CD1 expressing intestinal epithelial cells. Tissue removed from UC patients was also shown to contain increased numbers of nonclassical NKT cells that produce markedly increased amounts of IL-13 and that in keeping with epithelial damage being a key factor in UC, these NKT cells are cytotoxic for epithelial cells (J Clin. Investigation (2004) 113, 1490-1497). Methods of use claims are directed to treatments preventing the inflammatory response of colitis by modulating IL-13 and NKT cell activity and to methods for screening for therapeutic compounds effective for colitis.

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: April 30, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.