[Federal Register Volume 68, Number 245 (Monday, December 22, 2003)]
[Notices]
[Page 71115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: (301) 435-4632; Facsimile: (301) 402-0220; E-mail: 
[email protected].

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.
[FR Doc. 03-31404 Filed 12-19-03; 8:45 am]
BILLING CODE 4140-01-P