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Method for treating benign prostatic hypertrophy

Assignee: Immunolytics Inc
•
Filing: 1991-05-30
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Granted: 1992-05-26
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Expires: 2011-05-30
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Abstract

Abstract The invention provides a composition and method for treating benign prostatic hypertropy in mammals so as to cause the dissolution and regression of hypertrophied prostatic tissue and thereby provide relief from the obstructive symptoms associated with the disease. The present composition preferably comprises a sterile pyrogen-free solution of the hydrolytic enzymes collagenase and hyaluronidase, a nonionic surfactant, and an antibiotic; all provided, in a pharmaceutically acceptable, buffered, isotonic, aqueous carrier. The present method preferably comprises the direct intraprostatic injection of a safe and therapeutically effective dose of the composition via the transurethral route of administration.

Inventors

  • 👤 Muharrem Gokcen
  • 👤 Terry J. Guy

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-26 09:44
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/43; A61K38/46; A61K38/48; A61K38/4886; A61K38/47; C; C12; C12Y; C12Y302/00; C12Y302/01; C12Y302/01035

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 93 words
A method of treating prostatic hypertrophy in a living mammal comprising direct intraprostatic injection of a composition comprising a therapeutically effective concentration of collagenase and at least one enzyme selected from the group consisting of hyaluronidase, elastase, trypsin, chymotrypsin, pronase, DNase I, bromelin, 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 leukocyte serine proteases; wherein said composition causes the dissolution and regression of hypertrophied prostatic tissue thereby providing relief from the obstructive symptoms associated with prostatic hypertrophy.
Claim 2
Independent Claim 93 words
A method of treating prostatic hypertrophy in a living mammal comprising direct intraprostatic injection of a composition comprising a therapeutically effective concentration of collagenase and at least one enzyme selected from the group consisting of hyaluronidase, elastase, trypsin, chymotrypsin, pronase, DNase I, bromelin, 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 leukocyte serine proteases; wherein said composition causes the dissolution and regression of hypertrophied prostatic tissue thereby providing relief from the obstructive symptoms associated with prostatic hypertrophy.
Claim 3
Dependent Claim 25 words
The method of claim 1 wherein said enzyme is selected from the group consisting of hyaluronidase, trypsin, chymotrypsin, pronase, elastase, DNase I, dispase, and plasmin.
Claim 4
Dependent Claim 10 words
The method of claim 2 wherein said enzyme is hyaluronidase.
Claim 5
Dependent Claim 31 words
The method of claim 3 wherein said collagenase is present at a concentration of about 250 to 250,000 U/ml and said hyaluronidase at a concentration of about 160 to 160,000 U/ml.
Claim 6
Dependent Claim 31 words
The method of claim 4 wherein said collagenase is present at a concentration of about 2,500 to 25,000 U/ml and said hyaluronidase at a concentration of about 1,600 to 16,000 U/ml.
Claim 7
Dependent Claim 17 words
The method of claim 1 wherein said composition further includes an effective concentration of a nonionic surfactant.
Claim 8
Dependent Claim 37 words
The method of claim 6 wherein said nonionic surfactant is selected from the group consisting of ethylene oxide esters of C 10 -C 20 fatty acids, and ethylene oxide esters of C 8 -C 22 alkyl alcohols.
Claim 9
Dependent Claim 11 words
The method of claim 4 wherein said intraprostatic injection is intralesional.
Claim 10
Dependent Claim 26 words
The method of claim 8 wherein the route of said intraprostatic injection is selected from the group consisting of transurethral, transrectal, and transperineal routes of injection.
Claim 11
Dependent Claim 17 words
The method of claim 9 wherein said intraprostatic injection is performed via the transurethral route of injection.
Claim 12
Dependent Claim 17 words
The method of claim 4 wherein said composition further includes an effective concentration of a nonionic surfactant.
Claim 13
Dependent Claim 16 words
The method of claim 11 wherein said composition further includes an effective concentration of an antibiotic.
Claim 14
Dependent Claim 23 words
The method of claim 4 wherein said composition is administered as a single injection at a dosage of about 1 to 20 ml.
Claim 15
Dependent Claim 23 words
The method of claim 13 wherein said composition is administered as a single injection at a dosage of about 1 to 5 ml.
Claim 16
Dependent Claim 34 words
The method of claim 1 wherein said composition is administered in a series of daily, weekly, or monthly injections at dosages of about 1 to 20 ml until the therapeutically desired result is obtained.
Claim 17
Dependent Claim 14 words
The method of claim 15 wherein said dosages are about 1 to 5 ml.
Claim 18
Dependent Claim 32 words
The method of claim 1 wherein said composition is administered as a depot formulation that permits sustained release, prevents access to the general circulation, or increases the prostate-specific localization of said composition.
Claim 19
Dependent Claim 29 words
The method of claim 1 wherein said depot formulation is provided as a slow release implant, is microencapsulated, or is attached to a biodegradable polymer or a prostate-specific immunoglobulin.
Claim 20
Dependent Claim 77 words
The method of claim 1 wherein said composition is a sterile pyrogen-free solution of about 2,500 to 25,000 U/ml collagenase, 1,600 to 16,000 U/ml hyaluronidase, and further including an effective concentration of a nonionic surfactant, and an effective concentration of an antibiotic; said composition provided in a pharmaceutically acceptable aqueous carrier having a physiologic pH and suitable for administration to living mammals at dosages of about 1 to 20 ml via the transurethral route of intraprostatic injection.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1995-05-26 1995-11-25 1996-05-26 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-05-26 1999-11-25 2000-05-26 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-05-26 2003-11-25 2004-05-26 $7700.00 Window Closed / Lapsed

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