[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
