[Federal Register Volume 64, Number 134 (Wednesday, July 14, 1999)]
[Notices]
[Pages 37989-37990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; Availability for Licensing: ``Methods 
for Predicting the Efficacy of a Chemotherapeutic Regimen for 
Gastrointestinal Cancers Using Antibodies Specific for Thymidylate 
Synthase''

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:
    Invention Title: ``Methods for Predicting the Efficacy of a 
Chemotherapeutic Regimen for Gastrointestinal Cancers using Antibodies 
specific for Thymidylate Synthase''
    Inventors: Drs. Patrick G. Johnson (NCI), Edwin R. Fisher (NCI) and 
Carmen J. Allegra (NCI)
    DHHS Ref. No. E-194-95/1 USPA SN: 08/758,034 [= 60/007,825--Filed: 
December 1, 1995] Filed: November 27, 1996 [E-194-95/1].
    Gastric adenocarcrinoma is characterized by an extremely virulent 
behavior and for which mortality approximates the incidence. The vast 
majority of patients with gastric cancer are diagnosed with advanced 
stage disease and even after ``curative''

[[Page 37990]]

gastrectomy, most will die from recurrent disease. Recently, there has 
been increasing interest in the use of neoadjuvant or primary 
chemotherapy, frequently using fluropyrimidine-based combination 
chemotherapy, in an attempt to increase respectability and improve 
survival or patients with locally advanced gastric cancer. Neoadjuvant 
chemotherapeutic treatment provides an early opportunity to assess 
individual patient response using the in situ primary tumor. Overall 
response rates in studies using neoadjuvant 5-fluorouracial (``5-FU'') 
based regiments in locally advanced gastric cancer range from 25-45%. 
Therefore, at least half of all patients treated in this setting are 
being subjected to unnecessary toxicity and delay in operation with no 
therapeutic benefit. Strategies that would accurately predict tumor 
responsiveness to 5-FU therapy would provide an opportunity to 
selectively treat patients most likely to benefit from treatment and 
avoid unnecessary toxicity in those who would not.
    The `034 invention is directed to methods for determining whether a 
chemotherapeutic treatment is appropriate for patients afflicted with 
gastrointestinal cancers, comprising;
    a. Obtaining a solid tumor tissue sample from the patient;
    b. Measuring a thymidylate synthase expression level in the tissue 
sample; and
    c. Comparing the thymidylate synthase expression level with a group 
of standard tumor tissue samples, the standards having known 
thymidylate synthase expression levels and known responses to the 
chemotherapeutic treatment, to determine if the chemotherapeutic 
treatment is appropriate for the patient.
    The above mentioned Invention is available, including any available 
foreign intellectual property rights, for licensing.

    Dated: July 2, 1999.
Jack Spiegel,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 99-17929 Filed 7-13-99; 8:45 am]
BILLING CODE 4140-01-M