[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