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[Federal Register Volume 62, Number 47 (Tuesday, March 11, 1997)]
[Notices]
[Page 11217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6002]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: IL-13 Receptor Specific 
Chimeric Proteins and Uses Thereof

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
404.7(a)(1)(I), announces that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive world-wide license in the field of therapeutics to treat 
cancer to NeoPharm, Inc. of Delaware to practice the inventions 
embodied in U.S. Patent Application 08/404,685 and corresponding 
foreign patent applications entitled ``IL-13 Receptor Specific Chimeric 
Proteins and Uses Thereof'' and E-266-94/1 entitled ``Compositions and 
Methods for Specifically Targeting Tumors.'' These inventions are owned 
by the Government of the United States of America as represented by the 
Department of Health and Human Services and the Pennsylvania State 
University.
    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, 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.

SUPPLEMENTARY INFORMATION: The patent application discloses the 
conjugation of human interleukin-13 (IL-13) to genetically engineered 
bacterial toxin--pseudomonas exotoxin (PE38QQR) molecule and its use as 
a diagnostic and therapeutic agent. The resulting chimeric toxin known 
as hIL13-PE38QQR binds only to cells expressing IL-13 receptors. 
Because of the chimerica molecule binds only to cells expressing the 
IL-13 receptor, i.e., tumor cells, the technology can be used to 
targets those cells. The improved specific targeting of this molecule, 
which is premised upon the discovery that tumor cells overexpress IL-13 
receptors at extremely high levels, permits the use of lower dosages of 
chimeric molecules to deliver effector molecules to the targeted tumor 
cells. The targeting of this chimeric molecule has been improved by 
adding a blocker of the interleukin-4 receptor. This invention will be 
useful in the treatment of cancer. Specifically, the targeting method 
could be used in conjunction with current methods, e.g., chemotherapy, 
the kill tumor cells while maintaining healthy cells. To date, the 
molecule has been shown to be effective against a variety of solid 
tumor cancers, including adenocarcinoma, colon cancer, breast cancer, 
ovarian cancer, kidney cancer, brain cancer and AIDS-associated 
Karposi's sarcoma.

ADDRESSES: Request for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licences 
should be directed to: Jaconda Wagner, J.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804; Telephone: (301) 496-7735 ext. 284; Facsimile: (301) 402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications. 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 licenses. Only written comments and/or 
applications for a license which are received by NIH on or before May 
12, 1997, will be considered. 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: Feburary 28, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-6002 Filed 3-10-97; 8:45 am]
BILLING CODE 4140-01-M
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