Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Multienzyme complexes or mixtures of enzymes
Reexamination Certificate
1999-10-28
2002-08-06
Caputa, Anthony C. (Department: 1642)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Multienzyme complexes or mixtures of enzymes
C424S094600, C424S094620, C424S094660, C424S094670, C436S064000
Reexamination Certificate
active
06428785
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a method for treating prostate cancer by administering collagenase alone or in combination with a glycosidase, a protease, a nuclease, a lipase, an esterase, a streptokinase, or a combination thereof. A typical embodiment includes administering a composition including a mixture of collagenase, hyaluronidase, a nonionic surfactant, an antibiotic, and calcium ions.
BACKGROUND OF THE INVENTION
Approximately ten million American men are believed to have prostate cancer today. Although fewer than 3% of men with the disease die from it, prostate cancer still is the second most common cause of cancer death among men. The cancer usually is localized in the prostate, but in some cases, the cancer is not diagnosed until it has metastasized to the bone, kidneys, or the brain.
Yearly screening for the disease increases the likelihood of early detection, especially prior to the disease metastasizing. Such screening usually involves a digital rectal exam and a prostate-specific-antigen (PSA) blood test. Other screening methods include ultrasound imaging, radionucleid scan, and biopsy.
The PSA blood test has revolutionized the early diagnosis of prostate cancer and the effectiveness of treatment. PSA is a proteolytic enzyme in the family of serine proteases and one of the most abundant proteins in the prostate secretions. PSA is synthesized in the ductal epithelium and prostatic acini and is located within the cell in cytoplasmic granules and vesicles, rough endoplasmic reticulum, vacuoles, secretory granules, and lyosomal dense bodies. PSA is secreted into the lumina of the prostatic ducts where it becomes a component of seminal plasma. To reach blood serum, PSA diffuses from luminal cells through the epithelial basement membrane and prostatic stroma and either passes through the capillary basement membrane and epithelial cells or into the lymphatics. Once in the bloodstream, the majority of PSA forms complexes with &agr;-1-antichymotrypsin (PSA-ACT) and &agr;-2-macroglobulin, while small quantities remain free (free PSA). Free PSA levels are usually elevated in instances of prostate cancer.
Once prostate cancer is diagnosed, a suitable method of treatment must be determined and then administered. Current methods of treatment include radical prostatectomy, radiation, and hormonal suppression. To determine the appropriate method of treatment, factors such as the age of the patient and severity of the disease are often considered. The disease generally is more aggressive for younger patients. Any tumor greater than 0.5 cc is typically considered clinically significant. The preferred treatment for localized prostate cancer is radical prostatectomy. This treatment may result in death, incontinence, impotence, rectal injury, or pulmonary emboli.
Thus, it is desirable to provide improved methods of treatment for prostate cancer that reduce the likelihood of one or more of these unpleasant side effects. In particular, it is desirable to provide improved methods of treatment that reduce the likelihood of the treatment rendering the patient impotent.
SUMMARY OF THE INVENTION
The current invention is directed to a method of treating prostate cancer in a living mammal. In one aspect, the treatment is directed to activating PSA in vivo. PSA in or near the prostate can be activated by one of several methods, such as by local administration of calcium ion preferably in combination with collagenase and, optionally, another hydrolase such as hyaluronidase.
PSA is a proteolytic enzyme, which is one of the most abundant proteins in the prostate secretion. Activated PSA may degrade prostate cancerous tumors by, for example, interfering with the initial growth stage of a tumor and/or interfering with the angiogenesis stage. The initial stage of prostate cancer growth involves the tumor growing to about the size of a pea. The tumor cannot get any larger unless it can form its own blood vessels around and inside the tumor, a process known as angiogenesis. Angiogenesis involves sending chemical signals to surrounding blood vessels that erode the vessel walls, sending capillaries toward the tumor. By interfering with angiogenesis, the tumor cannot grow beyond its initial size. In one aspect, PSA may be activated by administering calcium ions.
In another aspect, a method of treating prostate cancer is directed to administering a composition that includes a therapeutically effective concentration of a collagenase. Collagenase may degrade prostate cancerous tumors by, for example, supporting connective tissue around and inside of the cancerous tumor including angiogenesis-generated capillaries.
In another aspect, a method of the invention is directed to local administration of a therapeutically effective concentration of collagenase in combination with a glycosidase, a protease, a nuclease, a lipase, an esterase, a streptokinase, or a combination thereof. Preferably a glycosidase, such as, for example, hyaluronidase, is administered with collagenase.
Compositions used in methods of the invention may also include or be administered in combination with calcium ions, a nonionic surfactant, such as, for example, Triton® X-100, and an antibiotic, such as, for example, gentamicin.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a method for treating prostate cancer. In accordance with the present invention, it has been found that compositions containing at least one hydrolytic enzyme can be used to treat prostate cancer. “Treatment” and “treating” as used herein include preventing, inhibiting, curing, and alleviating prostate cancer or symptoms thereof and preventing or alleviating the metastasis of prostate cancer.
Alleviating prostate cancer includes degrading a prostate tumor, for example, breaking down the structural integrity or connective tissue of a prostate tumor, such that the tumor size is reduced when compared to the tumor size before treatment. Curing prostate cancer includes degrading a prostate tumor such that a tumor cannot be detected after treatment. The tumor may be reduced in size or become undetectable, for example, by atrophying from lack of blood supply or by being attacked or degraded by one or more components administered according to a method of the invention.
Alleviating metastasis of prostate cancer includes reducing the rate at which the prostate cancer spreads to other organs. Preventing metastasis of prostate cancer includes preventing the prostate cancer from spreading outside of the prostate.
A treatment according to the invention may be carried out by administering a therapeutically effective concentration of a composition including collagenase in an amount effective for alleviating, curing, inhibiting, or preventing prostate cancer or preventing or alleviating the metastasis of prostate cancer.
The composition including collagenase is locally administered to the prostate. Local administration includes delivering the composition into or near the prostate and/or cancerous tumor. Local administration further includes surrounding the prostate and/or cancerous tumor with the composition or applying the composition to the surface of the prostate and/or cancerous tumor. Cancerous tumor includes prostate cancer, cancerous cells, and the like.
Another treatment according to the invention may be carried out by activating PSA in vivo. Activating PSA in vivo includes activating PSA, typically the mammal's endogenous PSA, in and/or near the prostate. PSA is a proteolytic enzyme that, upon being activated, can facilitate dissolution or degradation of a prostate tumor. In one embodiment, PSA can be activated by locally administering calcium ions to the prostate.
Although the methods of the invention are not meant to be limited to a single theory, one theory directed to how the methods of the invention treat prostate cancer will be described. In initial stages, a cancerous tumor grows to about the size of a pea. Through angiogenesis the tumor then grows larger (i.e., the tumor grows blood vessels around and inside itsel
Caputa Anthony C.
Immunolytics Inc.
Merchant & Gould P.C.
Nickol Gary B.
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