[Federal Register Volume 64, Number 219 (Monday, November 15, 1999)]
[Notices]
[Pages 61915-61916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29635]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: ``Diagnostic and
Therapeutic Methods of Detecting and Treating Cancers of Reproductive
Tissues''
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 National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive world-wide license to the U.S. Patent Application 60/098,993,
entitled, ``Diagnostic and Therapeutic Methods of Detecting and
Treating Cancers of Reproductive Tissues'' and corresponding foreign
patent applications to IDEC Pharmaceuticals, Inc. of San Diego,
California. The United States of America is an assignee of the patent
rights in these inventions and the contemplated exclusive license may
be limited to the use of PAGE-4 plasmid DNA and/or PAGE-4 protein as a
vaccine to produce an immune response in humans to eliminate PAGE-4
expressing prostate cancer cells.
DATES: Only written comments and/or applications for a license which
are received by NIH on or before January 14, 2000.
ADDRESSES: Requests for copies of the patent applications, inquiries,
comments and other materials relating to the contemplated licenses
should be directed to: J.R. Dixon, Ph.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. 206; Facsimile: (301) 402-0220, E-
Mail: [email protected]. A signed Confidentiality Agreement will be
required to receive copies of any of the patent applications.
Technology Description
PAGE-4 is a human X-linked gene that is strongly expressed in
prostate and prostate cancer, and is also expressed in other male and
female reproductive tissue (e.g., testis, fallopian tube, placenta,
uterus, and uterine cancer). PAGE-4 shows similarity with the GAGE
protein family, but it diverges significantly from members of the
family so that it appears to belong to a separate family. This, and the
existence of another gene, PAGE-2, that share more homology with PAGE-4
than with members of the GAGE family indicates that the PAGE-4 protein
belongs to a separate protein family.
The specific detection of PAGE-4 might be valuable for the
diagnosis of prostate and testicular tumors, as well as uterine tumors.
There are sufficient differences between PAGE-4 and other members of
the PAGE and MAGE proteins to produce specific antibodies. Analyses
with such antibodies are needed to confirm by immunohistology the
expression specificity that is seen in database and mRNA analyses, and
to evaluate whether anti-PAGE 4 immunotherapy could be a promising
therapeutic approach. One possibility of eliminating PAGE-4 expressing
cells could be to use it as a cancer vaccine. Among the many possible
approaches to vaccination, one method is direct vaccination with
plasmid DNA. In fact, a laboratory at the NIH has been able to obtain
good expression of the PAGE-4 protein with mammalian expression
plasmids, and has demonstrated that DNA-immunization with such
expression constructs leads to good immune responses. Hence, this
method may generate anti-PAGE-4 responses, and allow one to analyze if
``PAGE-4-vaccination'' can eliminate PAGE-4 expressing cells, as a
therapeutic approach towards neoplasms of the prostate, testis, and
uterus.
Prostate Cancer
Prostate Cancer is a disease affecting approximately 1 million men
in the U.S.A., with an annual incidence of around 300,000 and
approximately 40,000 deaths per year. Control of primary tumor by
surgical resection and/or radiation has proven effective in a number of
cases, however, metastatic spread, primarily to the bone, especially at
late hormone independent stages of the disease, has been more difficult
to control and monitor.
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
and may be limited to the field of use of PAGE-4 plasmid DNA and/or
PAGE-4 protein as a vaccine to produce an immune response in humans to
eliminate PAGE-4 expressing prostate cancer cells. 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 exclusive license would
not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR
404.7.
Applications for a license [i.e., completed ``Application for
License to Public Health Service Inventions''] filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections will not be
made available for public inspection and, to the extent permitted by
law, will not be subject to disclosure under the Freedom of Information
Act, 5 U.S.C. 552.
[[Page 61916]]
Dated: November 5, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer.
[FR Doc. 99-29635 Filed 11-12-99; 8:45 am]
BILLING CODE 4140-01-P