[Federal Register Volume 64, Number 224 (Monday, November 22, 1999)]
[Notices]
[Pages 63820-63821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30341]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; Availability for Licensing: 
``Extracellular cAMP-Dependent Protein Kinase in the Diagnosis and 
Prognosis of Cancer and Methods of Treatment''

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, 
at the Office of Technology Transfer, National Institutes of Heath, 
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: ``Extracelular cAMP-Dependent Protein Kinase in 
the Diagnosis and Prognosis of Cancer and Methods of Treatment''.
    Inventor: Dr. Yoon S. Cho-Chung (NCI).
    U.S. Patent Application Serial No.: 60/140,288 filed June 18, 1999.
    DHHS Ref. No.: E-110-99/0

Abstract

    It has been discovered that expression of extracellular-PKA (ECPKA) 
is serum is a measure of hormone-dependency of breast cancer. In view 
of this discovery, this invention provides a method of determining 
whether or not breast cancer in a give patient is hormone-dependent or 
hormone-independent. Current methods of determining hormone-dependency 
in breast cancer involve biopsy and examination of the breast cancer 
tissue for the presence of estrogen and/or progesterone receptors, 
which can be detected in the tissue by an immunohistochemical assay 
using a monoclonal antibody, by a biochemical assay using dextran-
coated charcoal, and by other means. Such methods are disadvanageous 
due to inaccuracies (As much as 30-40% of results are false positives 
or false negatives), a lack of

[[Page 63821]]

consensus as to the minimum number of cells required to have an 
estrogen and/or progesterone receptor for determination of hormone-
dependent cancer, and required biopsy. The present invention seeks to 
overcome such disadvantages by providing a more accurate assay for the 
hormone dependency or independency of breast cancer which does not 
require biopsy.
    The determination of whether a breast cancer is hormone-dependent 
or hormone-independent has meaningful implications for the selection of 
treatment strategy and the prognosis of the disease. For example, if 
the breast cancer is hormone-dependent, the treatment may include 
hormone therapy involving administration of anti-estrogen drugs, the 
destruction of ovary function, or the removal of the ovaries. In the 
case of hormone-independence the absence of estrogen receptors in the 
primary tumor indicates a higher rate of recurrence and a shorter 
survival rate. In this instance the treatment will likely include the 
administration of chemotherapeutic drugs.

Technology

    This invention provides a method of diagnosing cancer in a patient. 
The method involves assaying a sample of serum or other body fluids 
from the patient for the presence of ECPKA. An elevated level of ECPKA 
in the sample compared to the level in a control sample is indicative 
of cancer in the patient. The invention also includes a method of 
assaying a sample of serum or other body fluids from the patient for 
the presence of ECPKA in which (i) A reduction in the level of ECPKA in 
the sample as compared to the level in an earlier sample from the 
patient indicates an improvement in the patient's prognosis, (ii) no 
change in the level of ECPKA in the sample as compared to the level of 
ECPKA in an earlier sample from the patient, indicates no change in the 
patient's condition, or (iii) an increase in the level of ECPKA in the 
sample as compared to the level in an earlier sample from the patient, 
indicating a worsening of the patient's condition. As alluded to above, 
the invention also involves a method of determining whether a diagnosed 
breast cancer is hormone-dependent or hormone-independent. This method 
involves assaying a serum or other body fluid sample from the patient 
for the presence of ECPKA versus a control sample. An elevated level of 
ECPKA indicates that the breast cancer is hormone-dependent. Finally, 
the invention provides a method for the treatment of cancer. This 
method involves reducing the level of ECPKA by delivering the 
RII subunit of PKA-II to target cancer cells to down-regulate 
the expression of ECPKA and inhibit cancer cell growth.
    The above mentioned Invention is available, including any available 
foreign intellectual property rights, for licensing.

    Dated: November 15, 1999.
Jack Spiegel,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer.
[FR Doc. 99-30341 Filed 11-19-99; 8:45 am]
BILLING CODE 4140-01-M