Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant...
Patent
1981-08-28
1984-05-01
Padgett, Benjamin R.
Drug, bio-affecting and body treating compositions
Radionuclide or intended radionuclide containing; adjuvant...
435 4, 435 7, 435240, 436516, 436518, 436536, 436539, 436542, 436543, 436547, 436548, G01N 3356, G01N 3354, C12N 500, A61K 3702
Patent
active
044461224
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD OF THE INVENTION
This invention relates to a diagnostic reagent and method for the immunochemical detection of a human prostate antigen which is distinct from prostatic acid phosphatase. More particularly, this invention relates to a novel purified human prostate antigen and antibodies specific thereto which are suitable for use in prostatic cancer detection by laboratory methods.
BACKGROUND ART
Prostate cancer is very prevalent in old age, with approximately one half of all males over age 70 having been shown to develop prostatic cancer. This high incidence of prostate malignancy has led to the search for markers which may be used for its detection. The elevation of serum acid phosphatase activity in patients having metastasized prostate carcinoma was first reported by Gutman et al. in J. Clin. Invest. 17: 473 (1938). In cancer of the prostate, prostatic acid phosphatase is released from the cancer tissue into the blood stream with the result that the total serum acid phosphatase level greatly increases above normal values. Numerous studies of this enzyme and its relation to prostatic cancer have been made since that time, e.g., see the review by Yam in Amer. J. Med. 56: 604 (1974). However, the measurement of serum acid phosphatase by conventional spectrophotometric methods often fails to detect prostatic cancer in its early stages. In general, the activity of serum acid phosphatase is elevated in about 65-90 percent of patients having carcinoma of the prostate with bone metastatis; in about 30 percent of patients without roentgenological evidence of bone metastasis; and in about only 5-10 percent of patients lacking clinically demonstrable metastasis.
Prior art attempts to develop a specific test for prostatic acid phosphatase have met with only limited success because techniques which rely on enzyme activity on a so-called "specific" substrate cannot take into account other biochemical and immunochemical differences among the many acid phosphatases which are unrelated to enzyme activity of prostate origin. In the case of isoenzymes, i.e. genetically defined enzymes having the same characteristic enzyme activity and a similar molecular structure but differing in amino acid sequences and/or content and therefore immunochemically distinguishable, it would appear inherently impossible to distinguish different isoenzyme forms merely by the choice of a particular substrate. It is therefore not surprising that none of these prior art methods is highly specific for the direct determination of prostatic acid phosphatase activity; e.g. see Cancer 5: 236 (1952); J. Lab. Clin. Med. 82: 486 (1973); Clin. Chem. Acta. 44: 21 (1973); and J. Physiol. Chem. 356: 1775 (1975).
In addition to the aforementioned problems of non-specificity which appear to be inherent in many of the prior art reagents employed for the detection of prostate acid phosphatase, there have been reports of elevated serum acid phosphatase associated with other diseases, which further complicates the problem of obtaining an accurate clinical diagnosis of prostatic cancer. For example, Tuchman et al. in Am. J. Med. 27: 959 (1959) have noted that serum acid phosphatase levels appear to be elevated in patients with Gaucher's disease.
Due to the inherent difficulties in developing a "specific" substrate for prostrate acid phosphatase, several researchers have developed immunochemical methods for the detection of prostate acid phosphatase. However, the previously reported immunochemical methods have drawbacks of their own which have precluded their widespread acceptance. For example, Shulman et al., in Immunology 93: 474 (1964) described an immunodiffusion test for the detection of human prostate acid phosphatase. Using antisera prepared from a prostatic fluid antigen obtained by rectal massage from patients with prostatic disease, no cross-reactivity precipitin line was observed in the double diffusion technique against extracts of normal kidney, testicle, liver and lung. However, this method has the disadvantages of limited sensitiv
REFERENCES:
patent: 4331647 (1982-05-01), Goldenberg
Papsidero, L. D. et al., Progress in Clinical and Biological Research, vol. 75A, pp. 435-443 (1981).
Wang, M. C. et al., The Prostate, vol. 2, pp. 89-96 (1981).
Shulman, A. et al., Proc. Society for Experimental Biology and Medicine, vol. 137 (1) pp. 97-100 (1971).
Papsidero, L. D. et al., J. National Cancer Institute, vol. 66 (1), pp. 37-42 (1981).
Kuriyama, T. et al., Cancer Research, vol. 41 (10), pp. 3874-3876 (1981).
Clarke, S. M. et al., Medical and Pediatric Oncology, vol. 9 (1), p. 94 (1981).
Wang et al., Investigative Urology, vol. 17, No. 2, pp. 159-163 (1979).
Chu Tsann M.
Papsidero Lawrence
Wang Ming C.
Moskowitz M.
Padgett Benjamin R.
Research Corporation
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