Claims for Patent: 5,116,615

Summary for Patent: 5,116,615

Title:	Method for treating benign prostatic hypertrophy
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.
Inventor(s):	Gokcen; Muharrem (Minneapolis, MN), Guy; Terry J. (Chaska, MN)
Assignee:	Immunolytics, Inc. (Minneapolis, MN)
Application Number:	07/707,628
Patent Claims:	1. 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. 2. 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. 3. The method of claim 2 wherein said enzyme is hyaluronidase. 4. 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. 5. 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. 6. The method of claim 1 wherein said composition further includes an effective concentration of a nonionic surfactant. 7. The method of claim 6 wherein said nonionic surfactant is selected from the group consisting of ethylene oxide esters of C.sub.10 -C.sub.20 fatty acids, and ethylene oxide esters of C.sub.8 -C.sub.22 alkyl alcohols. 8. The method of claim 4 wherein said intraprostatic injection is intralesional. 9. 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. 10. The method of claim 9 wherein said intraprostatic injection is performed via the transurethral route of injection. 11. The method of claim 4 wherein said composition further includes an effective concentration of a nonionic surfactant. 12. The method of claim 11 wherein said composition further includes an effective concentration of an antibiotic. 13. The method of claim 4 wherein said composition is administered as a single injection at a dosage of about 1 to 20 ml. 14. The method of claim 13 wherein said composition is administered as a single injection at a dosage of about 1 to 5 ml. 15. 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. 16. The method of claim 15 wherein said dosages are about 1 to 5 ml. 17. 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. 18. 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. 19. 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.

Details for Patent 5,116,615

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	11/10/1982		2009-05-26
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	08/21/1984		2009-05-26
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2009-05-26
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2009-05-26