[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] ----------------------------------------------------------------------- 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''
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