Claims for Patent: 10,369,110

Summary for Patent: 10,369,110

Title:	Treatment method and product for uterine fibroids using purified collagenase
Abstract:	The invention relates to compositions and methods for treating uterine fibroids, wherein a uterine fibroid treatment agent comprising collagenase in an amount effective to cause shrinkage of uterine fibroids is injected or inserted into the uterine fibroid.
Inventor(s):	Leppert; Phyllis Carolyn (Durham, NC), Wegman; Thomas L. (N. Merrick, NY)
Assignee:	BioSpecifics Technologies Corporation (Lynbrook, NY) Duke University (Durham, NC)
Application Number:	14/213,957
Patent Claims:	1. A method for the treatment of uterine fibroids in a patient comprising administering into the uterine fibroid a composition comprising an amount of collagenase from Clostridium histolyticum sufficient to cleave disordered collagen fibrils of types I, III and V in said uterine fibroids, wherein said administering is by injecting or inserting into the fibroid about 0.06 to about 1 mg of said collagenase per 1 cm.sup.3 uterine fibroid tissue. 2. The method of claim 1, wherein the collagenase is a mixture of collagenase I and collagenase II. 3. The method of claim 1, wherein about 0.1 mg to about 0.8 mg collagenase is administered per cm.sup.3 of tissue to be treated. 4. The method of claim 1, wherein about 0.2 mg to about 0.6 mg collagenase is administered per cm.sup.3 of tissue to be treated. 5. The method of claim 1, wherein said composition is injected or inserted into said fibroid transabdominally. 6. The method of claim 1, wherein said composition is injected or inserted into said fibroid transvaginally. 7. The method of claim 1, wherein said composition is injected or inserted into said fibroid under image guidance. 8. The method of claim 7, wherein said image is at least one of a direct visual image and a non-direct visual image. 9. The method of claim 8, wherein said direct visual image is a scope image. 10. The method of claim 8, wherein said non-direct visual image is an MRI image. 11. The method of claim 10, wherein said composition comprises an MRI contrast agent. 12. The method of claim 8, wherein said non-direct visual image is an ultrasound image. 13. The method of claim 12, wherein said composition comprises an ultrasound contrast agent. 14. The method of claim 8, wherein said non-direct visual image is a fluoroscopic image. 15. The method of claim 14, wherein said composition comprises an x-ray contrast agent. 16. The method of claim 1, wherein said composition further comprises a chemical ablation agent, a non-steroidal anti-inflammatory drug, an oral contraceptive, a GnRH agonist, an antiprogestogen, or a selective progesterone receptor modulator. 17. The method of claim 16, wherein said composition comprises a chemical ablation agent. 18. The method of claim 17, wherein said chemical ablation agent is a salt. 19. The method of claim 17, wherein said chemical ablation agent is selected from an enzyme, an acid, a base and an oxidizing agent. 20. The method of claim 1, wherein said composition comprises one or more uterine fibroid treatment agents. 21. The method of claim 1, wherein said composition is a solid dosage form having a largest dimension between 1 mm and 20 mm. 22. The method of claim 1, wherein said composition is delivered through a delivery channel into said fibroid, wherein the delivery channel is in a needle, syringe, cannula, catheter or jet injector. 23. The method of claim 1, wherein said composition is encapsulated. 24. The method of claim 1, wherein said composition is a powder. 25. The method of claim 24, wherein said powder is introduced into said fibroid by jet injection. 26. The method of claim 1, wherein the composition further comprises a viscosity adjusting agent is present in an amount effective to provide a viscosity ranging from 10,000 centipoise to 50,000 centipoise. 27. The method of claim 1, wherein said composition is a fluid formulation that is crosslinked in vivo. 28. The method of claim 1, wherein said composition comprises an alginate polymer. 29. The method of claim 1, wherein said composition comprises gelatin. 30. The method of claim 1, wherein the composition provides sustained release of an amount of said collagenase sufficient to treat said uterine fibroids. 31. The method of claim 1, wherein 100 .mu.L of said composition is injected or inserted into 1 cm.sup.3 uterine fibroid tissue. 32. A method for the treatment of uterine fibroids in a patient, comprising administering into the uterine fibroid a composition comprising an amount of collagenase from Clostridium histolyticum sufficient to cleave disordered collagen fibrils of types I, III and V in said uterine fibroids, wherein said amount is 0.25-2.0 mg/mL collagenase from Clostridium histolyticum, and wherein said administering is by injecting or inserting said composition into the uterine fibroid tissue. 33. The method of claim 32, wherein said composition comprises 0.25 mg/mL collagenase from Clostridium histolyticum. 34. The method of claim 32, wherein said composition comprises 0.5 mg/mL collagenase from Clostridium histolyticum. 35. The method of claim 32, wherein said composition comprises 1.0 mg/mL collagenase from Clostridium histolyticum. 36. The method of claim 32, wherein said composition comprises 2.0 mg/mL collagenase from Clostridium histolyticum.

Details for Patent 10,369,110

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2033-03-15
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	02/02/2010		2033-03-15