E6-4074. Prospective Grant of Exclusive License: The Use of HMG-CoA Inhibitors for the Treatment of Adenocarcinomas and Ewing's Sarcoma

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 Part 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 patent license to practice the inventions embodied in U.S. Patent No. 6,040,334 issued March 21, 2000, entitled “Use of Inhibitors of 3-Hydroxy-3-Methylglutaryl Coenzyme A reductase as a Modality in Cancer Therapy” [HHS Reference E-146-1992/0-US-23] and related foreign applications to Nascent Oncology, Inc., which has offices in Chapel Hill, North Carolina. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of adenocarcinoma and Ewing's sarcoma with HMG-CoA inhibitors.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 22, 2006 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, PhD, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology relates to the treatment of adenocarcinomas and Ewing's sarcoma with HMG-CoA inhibitors. Adenocarcinoma affects the inner lining or inner surface of a number of organs, and is responsible for approximately 95% of prostate cancers, over 75% of pancreatic cancers, and is the most common form of lung cancer. Ewing's sarcoma is a bone tumor typically attacking the long bones. Current methods of treating these cancers include surgery, chemotherapy, radiation therapy or a combination thereof.

The current technology involves the use of HMG-CoA inhibitors (such as lovastatin or simvastatin) to treat adenocarcinomas and Ewing's sarcoma. HMG-CoA inhibitors have been approved for use in the treatment of high cholesterol in humans, with typical doses of 10mg, 20mg or 40mg. This technology recommends using higher doses (based on the weight of the patient) for the treatment of cancer.

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 sixty (60) days from the date of this published notice, the 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.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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: March 13, 2006.

Steven M. Ferguson,

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