[Federal Register Volume 64, Number 37 (Thursday, February 25, 1999)]
[Notices]
[Pages 9337-9338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4658]


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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.

ADDRESS: 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.

Entitled: Methods for Determining the Prognosis of Breast Cancer 
Using Antibodies Specific for Thymidylate Synthase

    Inventors: Drs. Patrick G. Johnston (NCI) and Carmen J. Allegra 
(NCI), Serial No. 09/152,647 filed 14 September 1998.
    Thymidylate synthase provides the sole de novo source of 
thymidylate for DNA synthesis. It is also a critical therapeutic target 
for the fluoropyrimidine cytotoxic drugs, such as fluorouracil (``5-
FU'') and flurodeoxyureidine (``FudR''). In pre-clinical and clinical 
studies increased expression of thymidylate synthase protein has been 
associated with resistance to 5-FU. The quantitation of thymidylate 
synthase has traditionally been performed using enzymatic biochemical 
assays; however, these assays have major limitations when applied to 
human tumor tissue samples. Recently, monoclonal antibodies have been 
developed to human thymidylate synthase that have the required 
sensitivity and specificity to detect and quantitate thymidylate 
synthase enzyme in formalin-fixed tissue sections. Hence, this 
invention provides a method for determining the prognosis of a patient 
afflicted with breast cancer, by obtaining a solid breast tumor tissue 
sample, measuring the level of thymidylate synthase expression in the

[[Page 9338]]

tissue sample using antibody specific for thymidylate synthase. This 
invention further provides a method for predicting the benefit of 
chemotherapy for a patient afflicted with breast cancer. The above 
mentioned invention is derived from the discovery that high thymidylate 
synthase expression is associated with a poor prognosis in node-
positive, but not in node-negative, breast cancer patients. Further, 
with some 2,504 patients, thymidylate synthase expression was not found 
to be correlated with other prognostic factors including tumor size, ER 
status, PR Status, tumor grade, vessel invasion, and histology.
    The above mentioned invention is available for licensing on an 
exclusive or non-exclusive basis.

    Dated: February 16, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-4658 Filed 2-24-99; 8:45 am]
BILLING CODE 4140-01-M