E6-13936. 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.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR (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 restenosis and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions.

This notice replaces a notice published in 71 FR 46496, August 14, 2006, to correct the heading “Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions with Nitrite Therapy” to read “Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor”.

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

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, by the date referenced above, 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: August 15, 2006.

Steven M. Ferguson,

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