[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
