Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1998-11-18
2001-10-09
Eyler, Yvonne (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C530S329000, C530S300000, C435S004000, C435S007100, C435S007210, C436S064000
Reexamination Certificate
active
06300088
ABSTRACT:
FILED OF THE INVENTION
The present invention relates to methods of detecting Prostate Specific Antigen in a subject by detection of an activation peptide that is cleaved from the PSA proenzyme. Such methods aid in the detection, diagnosis and prognosis of diseases, including prostate disease and breast cancers.
BACKGROUND OF THE INVENTION
More than 1.3 million new cases of invasive cancer are expected to be diagnosed in the United States during 1997 (Parker et al.
CA Cancer J. Clin
. 47:5 (1997); this estimate does not include carcinoma in situ (except in the bladder), nor does it include basal and squamous cell cancers of the skin). Among women, it is estimated that the three most commonly diagnosed cancers in 1997 will be cancers of the breast, lung and bronchus, and colon and rectum. Breast cancer alone will account for 30% of new cancer cases in 1997. Among men, the most common cancers in 1997 will be cancers of the prostate, lung and bronchus, and colon and rectum, with prostate being the leading cancer site and accounting for 43% of new cancer cases.
Prostate cancer accounts for 36% of all male cancers and 13% of male cancer-related deaths (surpassed only by lung cancer). It is estimated that approximately 334,500 new cases of prostate cancer and 41,800 prostate cancer-related deaths will occur in the United States in 1997. Incidence rates of prostate cancer have increased over the past 35 years. Parker et al.
CA Cancer J. Clin
. 47:5 (1997). Screening for prostate cancer has traditionally relied on digital rectal screening. Transrectal ultrasound and measurement of prostate-specific antigen (PSA) in the blood have also recently become available to aid in the diagnosis of prostate cancer. See, e.g., Friedman et al.,
Lancet
337:1526 (1991); Littrup,
Cancer
74 (7 Suppl):2016. However, the cost, relatively low specificity, and invasiveness of rectal imaging techniques precludes these from use in routine or large-scale screening for prostate cancer. Additionally, the effectiveness of such techniques are non-specific and depend on the skill and experience of the examiner. Waterhouse and Resnick,
J. Urol
. 141:233 (1989); Waterhouse and Resnick,
Urology
, 36:18 (1990).
Benign Prostate Hypertrophy (BPH) is a common condition in men over the age of 50, and occurs in the majority of men over the age of 80. BPH and prostate cancer may occur simultaneously in a subject.
It is estimated that in 1997 breast cancer will account for 30 percent of new cancer cases, with about 180,200 new cases diagnosed. Parker et al.
CA Cancer J. Clin
. 47:5 (1997). Diagnosis of breast cancer typically depends on physical examination of the breast and/or routine mammography, with subsequent ultrasound and/or biopsy as indicated.
Due to the known association of PSA with diseases such as BPH and prostate and breast cancers, and the high incidence of such diseases, it would be advantageous to develop effective and convenient methods of screening for the presence of cancer.
SUMMARY OF THE INVENTION
A first aspect of the present invention is a method of screening a subject for secreted Prostate Specific Antigen (PSA), comprising obtaining a biological sample from a subject and detecting the amount of PSA activation peptide in the sample.
A further aspect of the present invention is a method of screening a subject for the presence of a condition associated with an increased level of secreted Prostate Specific Antigen (PSA), comprising obtaining a biological sample from a subject, detecting the amount of PSA activation peptide in the sample, and comparing the amount of peptide detected to a pre-determined standard. Detection of a level of peptide greater than that of the standard indicates the presence of the condition for which the screening is being carried out.
A further aspect of the present invention is a method of screening a subject for prostate disease, comprising obtaining a urine sample from the subject, and detecting the presence of PSA activation peptide in the sample. The presence of PSA activation peptide in the sample is indicative of prostate disease.
A further aspect of the present invention is an immunoassay method for determining the presence of a peptide of SEQ ID NO:1 in a sample, comprising obtaining a test sample, exposing the sample to an antibody specific for a peptide of SEQ ID NO:1; and detecting the binding of antibody to peptides present in the sample. Binding of antibodies indicates the presence of peptides of SEQ ID NO:1 in the sample.
A further aspect of the present invention is a method of screening for prostate cancer in a subject, comprising obtaining a biological sample (urine, blood, blood plasma or blood serum) from the subject, and detecting the presence of PSA activation peptide in the sample. The presence of the peptide is indicative of prostate cancer in the subject.
A further aspect of the present invention is an isolated peptide of SEQ ID NO:1.
A further aspect of the present invention is an antibody or antibody fragment that specifically binds to a peptide of SEQ ID NO:1.
REFERENCES:
patent: Re. 33405 (1990-10-01), Chu et al.
patent: 4446122 (1984-05-01), Chu et al.
patent: 5356781 (1994-10-01), Hermon-Taylor et al.
patent: 5501983 (1996-03-01), Lilja et al.
patent: 5506106 (1996-04-01), Croce et al.
patent: 5543296 (1996-08-01), Sobol et al.
patent: 5599677 (1997-02-01), Dowell et al.
patent: 5648478 (1997-07-01), Henderson
patent: 5654161 (1997-08-01), Tewari
patent: 5658730 (1997-08-01), McGill et al.
patent: 5672480 (1997-09-01), Dowell et al.
patent: 5688658 (1997-11-01), Diamandis
patent: 5723302 (1998-03-01), Diamandis
patent: 5817481 (1998-10-01), Rood
patent: WO 97/32215 (1997-09-01), None
patent: WO 98/49323 (1998-11-01), None
Reissigl et al., “Improvement of Prostate Cancer Screening by Determination of the Ratio Free/Total PSA in Addition to PSA Levels,” Prostate, 30(4), Mar. 1, 1997, pp. 243-247.
Marachal et al., “PSA and PS2 Expression in Prostatic Tissue,” Cancer Detec. Prevent., 20(5), Abstract, 1996, p. 514.
Belanger et al., “Molecular Mass and Carbohydrate Structure of Prostate Specific Antigen: Studies for Establishment of an International PSA Standard,” Prostate, 27(4), 1995, pp. 187-197.
Leinomen et al., “Double-Label Time-Resolved Immunofluorometric Assay of Prostate-Specific Antigen and of Its Complex with &agr;1-Antichymotrypsin,” Clin. Chem., 39(10), 1993, pp. 2098-2103.
Lundwall et al., “Molecular cloning of human prostate specific antigen cDNA,” Febs. Lett., 214(2), 1987, pp. 317-322.
Lilja et al., “Prostate Specific Antigen Predominantly Forms a Complex with Alpha1-Antichymotrypsin in Blood,” Cancer, 70 (1 Suppl), 1992, pp. 230-234.
Partin et al., “The Clinical Usefulness of Prostate Specific Antigen: Update 1994,” J. Urology, 152, (5 pt 1) 1994, pp. 1358-1368.
Stenman et al., “A Complex between Prostate-specific Antigen and &agr;1-Antichymotrypsin Is the Major Form of Prostate-specific Antigen in Serum of Patients with Prostatic Cancer: Assay of the Complex Improves Clinical Sensitivity for Cancer,” Cancer Res., 51(1), 1991, pp. 222-226.
Takayama et al., “Characterization of the Precursor of Prostate-specific Antigen,” J. Biol. Chem, 272, 1997, pp. 21582-21588.
Woolf, “Screening for Prostate Cancer with Prostate-Specific Antigen,” N. Engl. J. Med., 333, 1996, pp. 1401-1405.
Zhou et al., “Multiple Forms of Prostate-Specific Antigen in Serum: Differences in Immunorecognition by Monoclonal and Polyclonal Assays,” Clin. Chem., 39(12), 1993, pp. 2483-2491.
Mikolajczyk et al., “A Precursor Form of PSA (pPSA) is a Component of the Free PSA in Prostate Cancer Serum,” Urology, 50(5), 1997, pp. 710-714.
Zarghami et al., “Detection of prostate-specific antigen mRNA and protein in breast tumors,” Clinical Chemistry, 42(3), Mar. 1996, pp. 361-366.
Lehrer et al., “Reverse transcriptase-polymerase chain reaction for prostate-specific antigen may be a prognostic indicator in breast cancer,” British J. Cancer, 74, Sep. 1996, pp. 871-873.
Lai et al., “Prostate-Specific Antigen in Breast Cyst Fluid: Possible Role of Prostate-Specific Antigen i
Enghild Jan J.
Oury Tim D.
Thogersen Ida B.
Valnickova Zuzana
Walther Philip J.
Duke University
Eyler Yvonne
Hunt Jennifer
Myers Bigel & Sibley & Sajovec
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