[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)]
[Notices]
[Page 54336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally funded research and development.

ADDRESSES: Licensing information and a copy of the U.S. patent 
application referenced below may be obtained by contacting J.R. Dixon, 
Ph.D., at the Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804 (telephone 301/496-7056, ext. 206; fax 301/402-0220; E-Mail: 
[email protected]). A signed Confidential Disclosure Agreement is required 
to receive a copy of any patent application.

SUPPLEMENTARY INFORMATION:
    Title: ``Diagnostic and Therapeutic Methods of Detecting and 
Treating Cancers of Reproductive Tissues.''
    Inventors: Drs. Ira H. Pastan (NCI), Ulrich Brinkmann (NCI), George 
Vasmatzis (NCI) and Byungkook Lee (NCI).
    DHHS Ref. No. E-028-99/0--Filed with the U.S.P.T.O. September 1, 
1998.

Background

    The basis of cancer immunotherapy as a viable option of treatment 
rests on the supposition that tumor-specific antigens are expressed by 
the tumor cells, and that immune effector mechanisms can be induced 
selectively to destroy these tumor cells. Although a variety of host 
immune effector cells have been shown to participate in the killing of 
tumor cells, tumor-specific CD8+ Cytotoxic T Lymphocytes (``CTL'') are 
highly specific and effective in mediating tumor cell killing. CTLs 
that recognize tumor cells have been isolated from melanoma, breast, 
ovarian, renal, lung, colorectal and prostrate cancer patients. Their 
existence suggests that there is an immune response to cancer in these 
patients and that its augmentation might be therapeutically beneficial. 
Thus, approaches based on induction of tumor-specific CTLs by 
therapeutic vaccines may provide an attractive alternative for treating 
cancer patients.

Technology

    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 cancer vaccine. Among the many possible 
approaches to vaccination, one method is direct vaccination with 
plasmid DNA. In fact, Dr. Pastan's laboratory 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 us 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 above mentioned invention is available, including any available 
foreign intellectual property rights, for licensing on an exclusive or 
non-exclusive basis.

    Dated: September 28, 1999.
Jack Spiegel, Ph.D.,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer.
[FR Doc. 99-25950 Filed 10-5-99; 8:45 am]
BILLING CODE 4140-01-M