03-31404. Prospective Grant of Exclusive License: Use of Mutants of Human Insulin-Like Growth Factor Binding Protein-3 (IGFBP-3) in Treatment of Cancer

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 Food and Drug Administration and the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in International Patent Application PCT/US02/40561, “Use of Mutants of Human Insulin-Like Growth Factor Binding Protein-3 (IGFBP-3) in Treatment of Cancer”, by Matthew Rechler, filed on December 17, 2002, and claiming priority to U.S. provisional patent application 60/341,920 filed December 17, 2001, to Actis Biologics Inc., which is located in Livermore, California. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide and the field of use may be limited to human therapeutics for the treatment of prostate and breast cancers.

DATES:

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before February 20, 2004 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: Brenda J. Hefti, 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:

In this invention, human IGFBP-1 has been genetically modified so that its affinity for IGF-I and IGF-II is greatly reduced, and it can act only through a novel direct mechanism. These human IGFBP-3 mutants still can inhibit DNA synthesis and stimulate apoptosis, and have been shown to induce apoptosis in human prostate cancer cells. The current invention could selectively exert anti-proliferative action without interfering with IGF actions, and may have therapeutic uses as an anti-tumor agent.

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 establish 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: December 16, 2003.

Steven M. Ferguson,

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