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  Novel method of diagnosing, monitoring, staging, imaging and treating breast cancerUSPTO Application #: 20080107596Title: Novel method of diagnosing, monitoring, staging, imaging and treating breast cancer Abstract: The present invention provides new markers and methods for detecting, diagnosing, monitoring, staging, prognosticating, imaging and treating breast cancer. (end of abstract)
Agent: Kathleen A. Tyrrell Licata & Tyrrell P.c. - Marlton, NJ, US Inventors: Susana Salceda, Robert Cafferkey, Herve Recipon, Yongming Sun USPTO Applicaton #: 20080107596 - Class: 424 149 (USPTO) The Patent Description & Claims data below is from USPTO Patent Application 20080107596. Brief Patent Description - Full Patent Description - Patent Application Claims
INTRODUCTION [0001]This patent application is a continuation of U.S. patent application Ser. No. 09/721,183, filed Nov. 22, 2000, which claims the benefit of priority from U.S. Provisional Application Ser. No. 60/166,973, filed Nov. 23, 1999, teachings of each of which are hereby incorporated by reference in their entirety. FIELD OF THE INVENTION [0002]This invention relates, in part, to newly identified breast cancer specific genes and assays for detecting, diagnosing, monitoring, staging, prognosticating, imaging and treating cancers, particularly breast cancer. BACKGROUND OF THE INVENTION [0003]It is estimated that one out of every nine women in America will develop breast cancer sometime during her life based on a lifespan of 85 years. Annually, over 180,000 women in the United States are diagnosed with breast cancer and approximately 46,000 die from this disease. Every woman is at risk for breast cancer. However, a woman's chances of developing breast cancer increase as she grows older; 80 percent of all cancers are found in women over the age of 50. There are also several risk factors that can increase a woman's chances of developing breast cancer. These include a family history of breast cancer, having no children or the first child after the age of 30, and an early start of menstruation. However, more than 70 percent of women who develop breast cancer have no known risk factors. Less than 10 percent of breast cancer cases are thought to be related to the BRCA1 gene discovered in 1994. Researchers are now investigating the role of other factors such as nutrition, alcohol, exercise, smoking, and oral contraceptives in development of this gynecologic cancer. Mammograms, or special x-rays of the breast, can detect more than 90 percent of all cancers. [0004]Procedures used for detecting, diagnosing, monitoring, staging, and prognosticating breast cancer are of critical importance to the outcome of the patient. Patients diagnosed early generally have a much greater five-year survival rate as compared to the survival rate for patients diagnosed with distant metastasized breast cancer. New diagnostic methods which are more sensitive and specific for detecting early breast cancer are clearly needed. [0005]Breast cancer patients are closely monitored following initial therapy and during adjuvant therapy to determine response to therapy and to detect persistent or recurrent disease or metastasis. Thus, there is also clearly a need for cancer markers which are more sensitive and specific in detecting breast cancer recurrence. [0006]Another important step in managing breast cancer is to determine the stage of the patient's disease. Stage determination has potential prognostic value and provides criteria for designing optimal therapy. Generally, pathological staging of cancer is preferable over clinical staging because the former gives a more accurate prognosis. However, clinical staging would be preferred were it at least as accurate as pathological staging because it does not depend on an invasive procedure to obtain tissue for pathological evaluation. Staging of cancer would be improved by detecting new markers in cells, tissues or bodily fluids which could differentiate between different stages of invasion. [0007]New breast cancer specific genes, referred to herein as BCSGs, have now been identified for use in diagnosing, monitoring, staging, imaging and treating cancers, and in particular breast cancer. Accordingly, the present invention relates to new methods for detecting, diagnosing, monitoring, staging, prognosticating, in vivo imaging and treating cancer via a BCSG. BCSG refers, among other things, to native proteins expressed by the genes comprising the polynucleotide sequences of BCSG-1 or Gene ID 332369 (SEQ ID NO: 1), BCSG-2 or Gene ID 480489 (SEQ ID NO:2 or 18), BCSG-3 or Gene ID 274731 (SEQ ID NO:3 or 20), BCSG-4 or Gene ID 173388 (SEQ ID NO:4) or BCSG-5 or Clone ID 3040232, Gene ID 411152 (SEQ ID NO:5). Exemplary proteins expressed by genes BCSG-2 and BCSG-3 are depicted herein as SEQ ID NO:19 and SEQ ID NO:21. By "BCSG" it is also meant herein variant polynucleotides which, due to degeneracy in genetic coding, comprise variations in nucleotide sequence as compared to SEQ ID NO: 1, 2, 3, 4, 5, 18 or 20 but which still encode the same proteins. In the alternative, what is meant by BCSG as used herein, means the native mRNAs encoded by the genes comprising BCSG-1 or Gene ID 332369 (SEQ ID NO: 1), BCSG-2 or Gene ID 480489 (SEQ ID NO:2 or 18), BCSG-3 or Gene ID 274731 (SEQ ID NO:3 or 20), BCSG-4 or Gene ID 173388 (SEQ ID NO:4) or BCSG-5 or Clone ID 3040232, Gene ID 411152 (SEQ ID NO:5) or it can refer to the actual genes comprising BCSG-1 or Gene ID 332369 (SEQ ID NO: 1), BCSG-2 or Gene ID 480489 (SEQ ID NO:2 or 18), BCSG-3 or Gene ID 274731 (SEQ ID NO:3 or 20), BCSG-4 or Gene ID 173388 (SEQ ID NO:4) or BCSG-5 or Clone ID 3040232, Gene ID 411152 (SEQ ID NO:5), or levels of polynucleotides which are capable of hybridizing under stringent conditions to the antisense sequences of SEQ ID NO: 1, 2, 3, 4, 5, 18 or 20. [0008]Other objects, features, advantages and aspects of the present invention will become apparent to those of skill in the art from the following description. It should be understood, however, that the following description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only. Various changes and modifications within the spirit and scope of the disclosed invention will become readily apparent to those skilled in the art from reading the following description and from reading the other parts of the present disclosure. SUMMARY OF THE INVENTION [0009]Toward these ends, and others, it is an object of the present invention to provide BCSGs comprising a polynucleotide of SEQ ID NO:1, 2, 3, 4, 5, 18 or 20 or a variant thereof, a protein expressed by a polynucleotide of SEQ ID NO:1, 2, 3, 4, 5, 18 or 20 or variant thereof which expresses the protein; or a polynucleotide which is capable of hybridizing under stringent conditions to the antisense sequence of SEQ ID NO: 1, 2, 3, 4, 5, 18 or 20. [0010]Further provided is a method for diagnosing the presence of breast cancer by analyzing for changes in levels of BCSG in cells, tissues or bodily fluids compared with levels of BCSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein a change in levels of BCSG in the patient versus the normal human control is associated with breast cancer. [0011]Further provided is a method of diagnosing metastatic breast cancer in a patient having breast cancer which is not known to have metastasized by identifying a human patient suspected of having breast cancer that has metastasized; analyzing a sample of cells, tissues, or bodily fluid from such patient for BCSG; comparing the BCSG levels in such cells, tissues, or bodily fluid with levels of BCSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein an increase in BCSG levels in the patient versus the normal human control is associated with breast cancer which has metastasized. [0012]Also provided by the invention is a method of staging breast cancer in a human by identifying a human patient having breast cancer; analyzing a sample of cells, tissues, or bodily fluid from such patient for BCSG; comparing BCSG levels in such cells, tissues, or bodily fluid with levels of BCSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein an increase in BCSG levels in the patient versus the normal human control is associated with a cancer which is progressing and a decrease in the levels of BCSG is associated with a cancer which is regressing or in remission. [0013]Further provided is a method of monitoring breast cancer in a human patient for the onset of metastasis. The method comprises identifying a human patient having breast cancer that is not known to have metastasized; periodically analyzing cells, tissues, or bodily fluid from such patient for BCSG; comparing the BCSG levels in such cells, tissue, or bodily fluid with levels of BCSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein an increase in BCSG levels in the patient versus the normal human control is associated with a cancer which has metastasized. [0014]Further provided is a method of monitoring the change in stage of cancer in a human patient having breast cancer by looking at levels of BCSG in the human patient. The method comprises identifying a human patient having breast cancer; periodically analyzing cells, tissues, or bodily fluid from such patient for BCSG; comparing the BCSG levels in such cells, tissue, or bodily fluid with levels of BCSG in preferably the same cells, tissues, or bodily fluid type of a normal human control, wherein an increase in BCSG levels in the patient versus the normal human control is associated with breast cancer which is progressing and a decrease in the levels of BCSG is associated with breast cancer which is regressing or in remission. [0015]Further provided are methods of designing new therapeutic agents targeted to BCSGs for use in imaging and treating cancer. For example, in one embodiment, therapeutic agents such as antibodies targeted against a BCSG or fragments of such antibodies can be used to treat, detect or image localization of a BCSG in a patient for the purpose of detecting or diagnosing a disease or condition. In this embodiment, an increase in the amount of labeled antibody detected as compared to normal tissue would be indicative of tumor metastases or growth. Such antibodies can be polyclonal, monoclonal, or omniclonal or prepared by molecular biology techniques. The term "antibody", as used herein and throughout the instant specification is also meant to include aptamers and single-stranded oligonucleotides such as those derived from an in vitro evolution protocol referred to as SELEX and well known to those skilled in the art. Antibodies can be labeled with a variety of detectable labels including, but not limited to, radioisotopes and paramagnetic metals. Therapeutics agents such as small molecule and antibodies or fragments thereof which decrease the concentration and/or activity of a BCSG can also be used in the treatment of diseases characterized by overexpression of BCSG. In these applications, the antibody can be used without or with derivatization to a cytotoxic agent such as a radioisotope, enzyme, toxin, drug or a prodrug. [0016]Other objects, features, advantages and aspects of the present invention will become apparent to those of skill in the art from the following description. It should be understood, however, that the following description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only. Various changes and modifications within the spirit and scope of the disclosed invention will become readily apparent to those skilled in the art from reading the following description and from reading the other parts of the present disclosure. DESCRIPTION OF THE INVENTION [0017]The present invention relates to diagnostic assays and methods, both quantitative and qualitative for detecting, diagnosing, monitoring, staging, prognosticating, in vivo imaging and treating breast cancer by comparing levels of breast cancer specific genes (BCSGs) with levels of BCSGs in a normal human control. BCSG refers, among other things, to native proteins expressed by the genes comprising the polynucleotide sequences of BCSG-1 or Gene ID 332369 (SEQ ID NO: 1), BCSG-2 or Gene ID 480489 (SEQ ID NO:2 or 18), BCSG-3 or Gene ID 274731 (SEQ ID NO:3 or 20), BCSG-4 or Gene ID 173388 (SEQ ID NO:4) or BCSG-5 or Clone ID 3040232, Gene ID 411152 (SEQ ID NO:5). Exemplary proteins expressed by genes BCSG-2 and BCSG-3 are depicted herein as SEQ ID NO:19 and SEQ ID NO:21. The genes encoding these proteins (SEQ ID NO:18 and 20) as well as the proteins (SEQ ID NO:19 and 21) have been disclosed in GenBank as Accession No. AF016492.1 (SEQ ID NO:18), AAC27891.1 (SEQ ID NO:19), AF183819 (SEQ ID NO:20) and AAF23614.1 (SEQ ID NO:21). By "BCSG" it is also meant herein variant polynucleotides which, due to degeneracy in genetic coding, comprise variations in nucleotide sequence as compared to SEQ ID NO: 1, 2, 3, 4, 5, 18 or 20 but which still encode the same proteins. The native protein being detected may be whole, a breakdown product, a complex of molecules or chemically modified. In the alternative, what is meant by BCSG as used herein, means the native mRNAs encoded by the genes comprising BCSG-1 or Gene ID 3323C9 (SEQ ID NO: 1), BCSG-2 or Gene ID 480489 (SEQ ID NO:2 or 18), BCSG-3 or Gene ID 274731 (SEQ ID NO:3 or 20), BCSG-4 or Gene ID 173388 (SEQ ID NO:4) or BCSG-5 or Clone ID 3040232, Gene ID 411152 (SEQ ID NO:5) or it can refer to the actual genes comprising BCSG-1 or Gene ID 332369 (SEQ ID NO: 1), BCSG-2 or Gene ID 480489 (SEQ ID NO:2 or 18), BCSG-3 or Gene ID 274731 (SEQ ID NO:3 or 20), BCSG-4 or Gene ID 173388 (SEQ ID NO:4) or BCSG-5 or Clone ID 3040232, Gene ID 411152 (SEQ ID NO:5) or levels of polynucleotides which are capable of hybridizing under stringent conditions to the antisense sequences of SEQ ID NO: 1, 2, 3, 4, 5, 18 or 20. Such levels are preferably measured in at least one of, cells, tissues and/or bodily fluids, including determination of normal and abnormal levels. Thus, for instance, a diagnostic assay in accordance with the invention for diagnosing over-expression of a BCSG protein compared to normal control bodily fluids, cells, or tissue samples can be used to diagnose the presence of cancers, and in particular breast cancer. BCSGs may be measured alone in the methods of the invention, or, more preferably, in combination with other diagnostic markers for breast cancer including other BCSGs as described herein. Other breast cancer markers, in addition to BCSGs, useful in the present invention are known to those of skill in the art. Diagnostic Assays [0018]The present invention provides methods for diagnosing the presence of cancer, and in particular breast cancer, by analyzing for changes in levels of BCSG in cells, tissues or bodily fluids from a human patient compared with levels of BCSG in cells, tissues or bodily fluids of preferably the same type from a normal human control, wherein an increase in levels of BCSG in the patient versus the normal human control is associated with the presence of cancer. Continue reading... Full patent description for Novel method of diagnosing, monitoring, staging, imaging and treating breast cancer Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Novel method of diagnosing, monitoring, staging, imaging and treating breast cancer patent application. Patent Applications in related categories: 20080241062 - Cancerous disease modifying antibodies - The present invention relates to a method for producing cancerous disease modifying antibodies using a novel paradigm of screening. By segregating the anti-cancer antibodies using cancer cell cytotoxicity as an end point, the process makes possible the production of anti-cancer antibodies for therapeutic and diagnostic purposes. The antibodies can be ... ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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