Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or...
Reexamination Certificate
1998-04-15
2001-10-30
Ungar, Susan (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
C435S007100, C435S007400, C435S007900
Reexamination Certificate
active
06309816
ABSTRACT:
TECHNICAL FIELD
The present invention is in the field of diagnostic methods and, more specifically, the present invention is related to the diagnosis of cancer.
BACKGROUND OF THE INVENTION
The prostate gland is a site of significant pathology affected by conditions such as benign growth (BPH), neoplasia (prostatic cancer) and infection (prostatitis). Prostate cancer represents the second leading cause of death from cancer in man. However, prostate cancer is the leading site for cancer development in men. The difference between these two facts relates to prostatic cancer occurring with increasing frequency as men age, especially in the ages beyond 60, at a time when death from other factors often intervenes. Also, the spectrum of biologic aggressiveness of prostatic cancer is great, so that in some men following detection the tumor remains a latent histologic tumor and does not become clinically significant, whereas in other patients it progresses rapidly, metastasizes and kills the man in a relatively short 2 through 5 year period.
Prostate specific antigen (PSA) is a tissue specific glycoprotein which can only be found in the prostate gland and its secretions. Because of the tissue specificity of PSA, it is well known to be a unique indicator for the prostate function as described by Hara, M., et al.,
Two prostate specific antigens gamma
-
semino
-
protein and beta
-
microsemino
-
protein,
J. Lab. Clin. Med. 1989; 113: 541-48. PSA is therefore a particularly useful indicator in controlling patients after radical prostatectomy, and determining whether they suffer any further appearance of their prostate cancer because the operative intervention should have removed the entire prostate tissue and therewith also the possible source for releasing prostate specific antigen. In patients with a prostate cancer, in whom, through histological examination the cancer has been proven to be limited to the prostate organ, the value of PSA after radical prostatectomy falls under the detection level of the presently available immunoassays in 80-92% of the cases. A further increase in the PSA value is the earliest available indicator for a further appearance of the cancer after a complete prostatectomy.
Although the detection of PSA has certainly proved to be an indicator of the presence of prostate cancer, there is an unacceptable number of patients who have normal or near normal PSA serum levels but have prostate cancer. In addition, there are a large number of patients with abnormally high PSA serum levels that have a benign tumor.
Recently, it has been reported that measuring the ratio of free PSA to bound PSA in the serum is a more accurate method of diagnosing prostate cancer. However, this method, while reportedly more accurate in diagnosing prostate cancer than free PSA only, still misses a high number of patients with prostate cancer.
What is needed is a method that can be easily administered and accurately diagnose or provide prognosis for the presence of prostate cancer, preferably in its early stages.
SUMMARY OF THE INVENTION
The diagnostic method of the present invention provides a method of diagnosing prostate cancer by measuring the concentration of prostate specific antigen and creatine kinase enzymatic activity. A mathematical relationship between the two concentrations is then determined. It has been determined that if the prostate specific antigen concentration in the blood is normal or near normal and the creatine kinase value is lower than normal, than there is a high likelihood that the patient has prostate cancer.
The present invention also comprises an inhibitor of creatine kinase that is present in the blood of a patient with cancer, especially prostate cancer. It has been found that if a patient has cancer, the creatine kinase concentration as measured by electrophoresis is normal. If the creatine kinase is measured by assaying enzymatic activity, the creatine kinase enzymatic activity will be abnormally low indicating the presence of an inhibitor that is associated with the cancer.
As part of the present invention, another way of diagnosing cancer in a patient, especially prostate cancer, is to measure creatine kinase by electrophoresis and to measure creatine kinase enzymatic activity. If the concentration of creatine kinase by electrophoresis is higher than the concentration of creatine kinase enzymatic activity, then the patient has a high likelihood of having cancer.
The present invention also includes a diagnostic kit for the diagnosis of prostate cancer in a male human comprising a means for measuring the concentration of creatine kinase in the serum of the male human and a means for measuring the concentration of prostate specific antigen in the serum of the male human.
The present invention includes a diagnostic kit for measuring the concentration of the creatine kinase inhibitor that is associated with the cancer.
The diagnostic method of the present invention provides a method of easily and quickly diagnosing prostate cancer in men without having to resort to painful biopsies. Because the two proteins are already commonly measured in routine physicals, there is no need to introduce new tests into the physicians' standard battery of tests.
Accordingly, it is an object of the present invention to provide a diagnostic method that will accurately detect prostate cancer.
It is another object of the present invention to provide a method for detecting prostate cancer that uses commonly performed blood tests.
It is yet another object of the present invention to provide a method for diagnosing prostate cancer in patients with normal PSA levels.
These and other objects, features and advantages of the present invention will become apparent after a review of the following detailed description of the disclosed embodiments.
REFERENCES:
patent: 5769074 (1998-06-01), Barnhill et al.
patent: WO 96/26442 (1986-08-01), None
patent: WO 97/05553 (1997-02-01), None
patent: WO 97/29199 (1997-08-01), None
Zarghami, Nosratollah et al., “Quantification of Creatine Kinase BB Isoenzyme in Tumor Cytosols and Serum with an Ultrasensitive Time-Resolved Immunofluorometric Technique,”Clinical Biochemistry,vol. 28, No. 3, pp. 243-253 (1995).
Feld, Ronald D. et al., “The Presence of Creatine Kinase BB Isoenzyme in Patients with Prostatic Cancer,” Clinica Chimica Acta, vol. 100, No. 3, pp. 267-273 (1980).
Barnhill et al (J. Clin. Ligand Assay, 21:18-23), 1998.*
Duranyildiz et al (J. Tumor Marker Oncol, 14:39-46), 1999.
Barnhill Stephen D.
Madyastha Ramananda
Zhang Hong
Zhang Zhen
Horus Therapeutics, Inc.
Kilpatrick & Stockton LLP
Ungar Susan
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