[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9581-9582]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-77]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: Development and
Commercialization of Therapeutic Products for Breast Cancer
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), announces that the Department of Health and Human
Services is contemplating the grant of an exclusive license to practice
the inventions embodied in U.S. Patent Application No. 09/693,600 filed
October 20, 2000 entitled ``Method and Composition for Enhancing Immune
Response'' [E-037-2001/1-US-01]; Japanese Patent Application No. 2002-
555834 filed October 22, 2001 entitled ``Method and Composition for
Enhancing Immune Response'' [E-037-2001/1-JP-03]; and European Patent
Application No. 01989341.1 filed October 22, 2001 entitled ``Method and
Composition for Enhancing Immune Response'' [E-037-2001/1-EP-04]; to
ODC Therapy, Inc.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to therapeutic applications for breast
cancer patients expressing high levels of serum or plasma IgE.
DATES: Only written comments and/or license applications which are
received by the National Institutes of Health on or before April 21,
2008 will be considered.
ADDRESSES: Requests for copies of the patent and/or patent
applications, inquiries, comments and other materials relating to the
contemplated exclusive license should be directed to: Mojdeh Bahar,
J.D., M.A., Technology Licensing Specialist, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD. 20852-3804. Telephone: (301) 435-2950;
Facsimile: (301) 402-0220; E-mail: baharm@od.nih.gov.
SUPPLEMENTARY INFORMATION: The invention relates to a method of
inhibiting tumor growth which comprises the administration of an IL-13
inhibitor. Additionally, the invention relates to a method and
composition for enhancing an immune response in a subject by
administering to a subject an inhibitor of IL-13 or an inhibitor of an
NK-T cell. The method can be used to prevent growth of a tumor in a
subject, e.g., to inhibit tumor recurrence or metastasis. The method
can also be used to enhance a response to a vaccine in a subject. IL-13
is an interleukin which has potent immunomodulatory effects. It is
primarily secreted by TH2 lymphocytes. This invention relates to the
discovery of a role for IL-13 in the down-regulation of tumor
immunosurveillance. Using a mouse model in which tumors show a growth-
regression-recurrence pattern, the mechanisms for down-regulation of
cytotoxic T lymphocyte-mediated tumor immunosurveillance was
investigated. It was discovered that interleukin 4 receptor (IL-4R)
knockout mice, and downstream signal transducer and activator of
transcription 6 (STAT6) knockout mice, but not IL-4 knockout mice,
resisted tumor recurrence. Thus, IL-13, the only other cytokine that
uses the IL-4R-STAT6 pathway, was discovered to have a role in the
down-regulation of tumor immunosurveillance.
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.
[[Page 9582]]
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: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-3165 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P