Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Binds expression product or fragment thereof of...
Reexamination Certificate
1999-07-20
2003-11-18
Caputa, Anthony C. (Department: 1642)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Binds expression product or fragment thereof of...
C424S130100, C424S141100, C424S155100, C530S387100, C530S387700, C530S388100, C530S388800
Reexamination Certificate
active
06649163
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the treatment and diagnosis of cancer with biological agents.
BACKGROUND OF THE INVENTION
In spite of improved treatments for certain forms of cancer, it is still a leading cause of death in the United States. Since the chance for complete remission of cancer is, in most cases, greatly enhanced by early diagnosis, it is very desirable that physicians be able to detect cancers before a substantial tumor develops. However, the development of methods that permit rapid and accurate detection of many forms of cancers continues to challenge the medial community. One such illustrative form of cancer is prostate cancer.
Prostate cancer is the most common cancer in men with an estimated 317,000 cases in 1996 in the United States. It is the second leading cause of death among men who die from neoplasia with an estimated 40,000 deaths per year. Prompt detection and treatment is needed to limit mortality caused by prostate cancer.
Detection of Prostate Cancer
When it metastasizes, prostatic cancer has a distinct predilection for bone and lymph nodes. Saitoh et al., “Metastatic Patterns of Prostatic Cancer. Correlation Between Sites And Number Of Organs Involved,” Cancer, 54:3078-3084 (1984). At the time of clinical diagnosis, as many as 25% of patients have bone metastasis demonstrable by radionuclide scans. Murphy, G. P., et al., “The National Survey Of Prostate Cancer In The United States By The American College Of Surgeons,”
J. Urol
., 127:928-939 (1982). Accurate clinical evaluation of nodal involvement has proven to be difficult. Imaging techniques such as computed tomography (“CT”) or magnetic resonance (“MR”) imaging are unable to distinguish metastatic prostate cancer involvement of lymph nodes by criterion other than size (i.e., >1 cm). Therefore, by definition, these imaging modalities are inherently insensitive in the detection of small volume (<1 cm) disease as well as non-specific in the detection of larger volume adenopathy. A recent study assessed the accuracy of MR in patients with clinically localized prostate cancer. Rifkin et al., “Comparison Of Magnetic Resonance Imaging And Ultrasonography In Staging Early Prostate Cancer,”
N. Engel. J. Med
., 323:621-626 (1990). In this study, 194 patients underwent an MR and 185 of these patients had a lymph node dissection. 23 (13%) patients had pathologically involved lymph nodes. MR was suspicious in only 1 of these 23 cases resulting in a sensitivity of 4%. Similar results have also been noted with CT scans. Gasser et al., “MRI And Ultrasonography In Staging Prostate Cancer,”
N. Engl. J. Med
. (
Correspondence
), 324 (7) :49-495 (1991).
The elevation of serum acid phosphatase activity in patients having metastasized prostate carcinoma was first reported by Gutman et al.,
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 can be greatly increased above normal values. Numerous studies of this enzyme and its relation to prostatic cancer have been made since that time, e.g. Yam,
Amer. J. Med
. 56:604 (1974). However, the measurement of serum acid phosphatase is elevated in about 65-90 percent of patients having carcinoma of the prostate with bone metastasis; 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.,
Am. J. Med
. 27:959 (1959) 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 prostate 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.,
Immunology
93:474 (1964) described an immuno-diffusion 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 sensitivity, even with the large amounts of antigen employed, and of employing antisera which may cross-react with other, antigenically unrelated serum protein components present in prostatic fluid.
WO 79/00475 to Chu et. al. describes a method for the detection of prostatic acid phosphatase isoenzyme patterns associated with prostatic cancer which obviates many of the above drawbacks. However, practical problems are posed by the need for a source of cancerous prostate tissue from which the diagnostically relevant prostatic acid phosphatase isoenzyme patterns associated with prostatic cancer are extracted for the preparation of antibodies thereto.
In recent years, considerable effort has been spent to identify enzyme or antigen markers for various types of malignancies with the view towards developing specific diagnostic reagents. The ideal tumor marker would exhibit, among other characteristics, tissue or cell-type specificity. Previous investigators have demonstrated the occurrence of human prostate tissue-specific antigens.
Treatment of Prostate Cancer
As described in W. J. Catalona, “Management of Cancer of the Prostate,”
New Engl. J. Med
., 331 (15) :996-1004 (1994), the management of prostate cancer can be achieved by watchful waiting, curative treatment, and palliation.
For men with a life expectancy of less than 10 years, watchful waiting is appropriate where low-grade, low-stage prostate cancer is discovered at the time of a partial prostatectomy for benign hyperplasia. Such cancers rarely progress during the first five years after detection. On the other hand, for younger men, curative treatment is often more appropriate.
Where prostate cancer is localized and the patient's life expectancy is 10 years or more, radical prostatectomy offers the best chance for eradication of the disease. Historically, the drawback of this procedure is that most cancers had spread beyond the bounds of the operation by the time they were detected. However, the use of prostate-specific antigen testing has permitted early detection of prostate cancer. As a result, surgery is less extensive with fewer complications. Patients with bulky, high-grade tumors are less likely
Caputa Anthony C.
Cornell Research Foundation Inc.
Fish & Richardson P.C.
Nickol Gary
LandOfFree
Treatment and diagnosis of cancer does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Treatment and diagnosis of cancer, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Treatment and diagnosis of cancer will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3129788