Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Multienzyme complexes or mixtures of enzymes
Reexamination Certificate
1993-11-17
2001-10-02
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Multienzyme complexes or mixtures of enzymes
C424S094600, C424S094610, C424S094670, C514S968000, C514S975000
Reexamination Certificate
active
06296847
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a composition of hydrolytic enzymes for use in treating prostatic hypertrophy, particularly to the use of a composition comprising a mixture of collagenase, hyaluronidase, a nonionic surfactant, and an antibiotic, administered by intraprostatic injection to relieve the obstructive symptoms associated with benign prostatic hypertrophy in mammals.
BACKGROUND OF THE INVENTION
Benign prostatic hypertrophy (BPH) is one of the most common medical problems experienced by middle to older aged men. Urinary tract obstruction due to prostatic enlargement has been recognized since the earliest days of medicine. Hypertrophic enlargement of the prostate gland often leads to compression of the urethra resulting in obstruction of the urinary tract and the subsequent development of symptoms including frequent urination, nocturia, pain, discomfort, and embarrassment. The association of BPH with aging has been shown to exceed 50% in men over 50 years of age and increases in incidence to over 75% in men over 80 years of age. Symptoms of urinary obstruction occur most frequently between the ages of 65 to 70 when approximately 65% of the men in this age group have prostatic enlargement. Due to a continuing increase in life expectancy, the average age of the population of the United States is increasing. Accordingly, the number of men expected to develop clinical symptoms of BPH will also continue to increase.
Currently there is no effective nonsurgical method of treatment for BPH. Patients suffering from the obstructive symptoms of this disease are generally provided with only two options: continue to cope with the symptoms, or submit to surgical intervention. The incidence of BPH requiring surgical intervention has been found to increase progressively with age to a maximum of 11 per thousand in men more than 80 years of age. More than 350,000 patients per year undergo surgery for removal of prostatic tissue in the United States. It has been calculated that a 40 year old man has about a 10% chance of requiring a prostatectomy for benign disease if he lives to be 80 years old.
Those suffering from BPH are often elderly men, many with additional health problems that increase the risk of surgical procedures. Surgical procedures for the removal of prostatic tissue are associated with a number of hazards including: anesthesia associated morbidity; hemorrhage; pulmonary emboli; bladder perforation; incontinence; infection; urethral or bladder neck stricture; retention of prostatic chips; retrograde ejaculation; and impotence. Accordingly, a significant number of patients with symptoms severe enough to warrant surgical intervention are poor operative risks and are not able to undergo prostatectomy. There is no doubt regarding the need, importance, and value of an alternative nonsurgical method of treatment for those men who are poor surgical risks.
An alternative, nonsurgical method of therapy may be expected to yield savings in many areas such as: surgical costs; post-operative hospitalization; transfusion; antibiotics; out-patient visits; rehospitalization for complications; and other socio-economic costs related to recuperation and sick leave. The psychological complications of BPH in aging men due to loss of bladder control are significant. An alternative, nonsurgical form of therapy would improve the quality of life for many aging men in terms of frequency of urination, inconveniences, embarrassment, and loss of personal dignity. BPH is a disease with major costs for society. The development and implementation of an alternative nonsurgical therapy for BPH would provide major medical, economic, and psycho-social benefits.
Accordingly, a clear need exists for a safe, effective, nonsurgical treatment for prostatic hypertrophy. A further need exists for a treatment that poses little risk to the patient, is relatively inexpensive, and which can be performed as an out-patient procedure without the use of general anesthesia.
SUMMARY OF THE INVENTION
The present invention is directed to an enzyme composition and a method of using the enzyme composition for treatment of prostatic hypertrophy. The enzyme composition enzymatically dissolves prostatic tissue in order to relieve the obstructive symptoms of prostatic hypertrophy.
The method comprises administering by direct intraprostatic injection a therapeutically effective amount of a composition comprising an effective amount of hydrolytic enzymes, preferably two or more hydrolytic enzymes selected from the group consisting of collagenase, hyaluronidase, elastase, trypsin, chymotrypsin, pronase, DNase I, bromelain, clostripain, thermolysin, neuraminidase, phospholipase, cholesterol esterase, dispase, subtilisin, papain, chymopapain, plasminogen activator, plasmin, streptokinase, urokinase, fibrinolysin, serrathiopeptidase, pancreatin, amylase, lysozyme, cathepsin-G, and the PMN (polymorphonuclear) leukocyte serine proteases, provided in a pharmaceutically acceptable aqueous carrier. More preferably the hydrolytic enzymes comprise collagenase and at least one enzyme selected from the group consisting of hyaluronidase, trypsin, chymotrypsin, pronase, elastase, DNase I, dispase, and plasmin. Most preferably the hydrolytic enzymes comprise collagenase and hyaluronidase.
The present method preferably comprises the direct intraprostatic injection of a therapeutically effective unit dose of the composition, the composition preferably comprising collagenase and hyaluronidase in a pharmaceutically acceptable aqueous carrier, also preferably containing a surfactant and an antibiotic. The aqueous carrier is preferably sterile, pyrogen-free, buffered, and isotonic.
The compounds of the composition may be administered alone, sequentially, or preferably, combined with one another in the form of a liquid pharmaceutical unit dosage form suitable for injection. The dose of the composition administered may vary over a wide range as can readily be determined by the clinician. The preferred dosage for obtaining the desired therapeutic objective may vary depending on the age of the patient, nature and severity of disease, potency of the composition, and route of administration.
The preferred route of administration is by means of transurethral intraprostatic (intralesional) injection. Alternatively, the transperineal or transrectal routes of prostatic injection may be used. Treatment regimens encompassed by the present invention employ the intraprostatic injection of safe and effective amounts of the preferred composition in order to cause the solubilization and regression of obstructive prostatic tissue. The injections may be administered in daily, weekly, or monthly injection protocols until the therapeutically desired result is obtained.
The present invention is also directed to a kit comprising at least one separate injectable unit dosage of a pharmaceutical composition comprising an effective amount of the hydrolytic enzymes of the present invention, most preferably collagenase and hyaluronidase.
The terms “effective amount” or “effective concentration”, as used to describe concentrations of components of the present invention, is defined as the amount of the component that, when in combination with the other components, provides the desired inhibition of growth, alteration of morphology, and reduction in size of the prostate for the given patient. The reduction in size of the obstructive prostatic tissue and the subsequent alleviation of symptoms of urinary obstruction are indicative of successful therapy. Objective assessment of the effects of the therapy is measured by standard methods including urodynamic flow analysis, transurethral examination, or transrectal ultrasonography in conjunction with an obstructive symptom scoring chart.
DETAILED DESCRIPTION OF THE INVENTION
BPH—Introduction to the Problem
The development of BPH is a phenomenon of aging men. The prostate weighs a few grams at birth and at puberty undergoes an androgen induced growth reaching the adult size of 20 g by the second decade of life. The p
Gokcen Muharrem
Guy Terry J.
Immunolytics Inc.
Merchant & Gould P.C.
Witz Jean C.
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