Claims for Patent: 8,545,893

Summary for Patent: 8,545,893

Title:	Keratin biomaterials for treatment of ischemia
Abstract:	Provided herein are keratin compositions useful for treating ischemia and/or reperfusion injury, such as that associated with myocardial infarct, ischemic stroke, brain trauma such as traumatic brain injury, hypothermia, chronic wounds, and burns.
Inventor(s):	Van Dyke; Mark E. (Winston-Salem, NC), Smith; Thomas L. (Winston-Salem, NC), Callahan; Michael (Winston-Salem, NC), Burnett; Luke (Winston-Salem, NC)
Assignee:	Wake Forest University Health Sciences (Winston-Salem, NC)
Application Number:	13/043,062
Patent Claims:	1. A method of treating ischemia or reperfusion injury in a subject in need thereof, said method comprising administering a composition comprising a keratin to said subject in an amount effective to treat said ischemia or reperfusion injury, wherein said keratin is a combination of .alpha.-keratose and keratin associated proteins (KAP). 2. The method of claim 1, wherein said .alpha.-keratose has an average molecular weight of at least 30 kiloDaltons. 3. The method of claim 1, wherein said composition comprises from 1 to 10% by weight of said keratin. 4. The method of claim 1, wherein said keratin is from 3 to 5 percent by weight of said composition. 5. The method of claim 1, wherein said composition consists essentially of: (a) from 1 to 10 percent by weight of said keratin; and (b) from 90 to 99 percent by weight of an electrolyte solution; wherein said keratin is solubilized in said electrolyte solution to form a homogeneous liquid composition having (i) a pH of 7-8; (ii) an osmolarity of 200 to 500 milliosmoles/Liter; and (iii) a viscosity of 2 to 20 centipoise, as determined at a temperature of 37 degrees Celsius in a Brookfield viscometer having a cone and plate geometry with a cone angle of 0.02 radians at a constant frequency of 30 rotations per minute. 6. The method of claim 5, wherein said electrolyte solution is normal saline. 7. The method of claim 5, wherein said keratin is from 3 to 5 percent by weight of said composition. 8. The method of claim 1, wherein said composition is administered in combination with a thrombolytic or an anticoagulant. 9. The method of claim 8, wherein said composition is administered in combination with a thrombolytic. 10. The method of claim 9, wherein said thrombolytic is selected from the group consisting of: streptokinase, urokinase, alteplase, reteplase, and tenecteplase. 11. The method of claim 8, wherein said composition is administered in combination with an anticoagulant. 12. The method of claim 11, wherein said anticoagulant comprises heparin. 13. The method of claim 11, wherein said composition comprising a keratin further comprises said anticoagulant. 14. The method of claim 8, wherein said composition comprising a keratin further comprises said thrombolytic. 15. The method of claim 1, wherein said ischemia or reperfusion injury is myocardial infarction, ischemic stroke, ischemia or reperfusion injury associated with brain trauma, ischemia or reperfusion injury associated with hypothermia, ischemia or reperfusion injury associated with chronic wounds, or ischemia or reperfusion injury associated with burns. 16. The method of claim 1, wherein said ischemia or reperfusion injury is myocardial infarction, ischemic stroke, ischemia or reperfusion injury associated with brain trauma, or ischemia or reperfusion injury associated with hypothermia. 17. The method of claim 1, wherein said ischemia or reperfusion injury is myocardial infarction. 18. The method of claim 1, wherein said ischemia or reperfusion injury is ischemic stroke. 19. The method of claim 1, wherein said ischemia or reperfusion injury is ischemia or reperfusion injury associated with brain trauma. 20. The method of claim 19, wherein said brain trauma is traumatic brain injury (TBI). 21. The method of claim 1, wherein said ischemia or reperfusion injury is ischemia or reperfusion injury associated with hypothermia. 22. The method of claim 1, wherein said composition is formulated for parenteral administration. 23. A method of treating ischemia or reperfusion injury in a subject in need thereof, said method comprising administering a composition comprising a keratin to said subject, wherein said keratin is combination of .alpha.-keratose and keratin associated proteins (KAP), and wherein said composition is administered in an amount effective to increase arteriolar diameter by 15 to 50%. 24. The method of claim 23, wherein said composition comprises from 1 to 10% by weight of said keratin. 25. The method of claim 23, wherein said keratin is from 3 to 5 percent by weight of said composition. 26. The method of claim 23, wherein said composition is administered in combination with a thrombolytic or an anticoagulant. 27. The method of claim 23, wherein said ischemia or reperfusion injury is myocardial infarction, ischemic stroke, ischemia or reperfusion injury associated with brain trauma, or ischemia or reperfusion injury associated with hypothermia. 28. The method of claim 23, wherein said composition is formulated for parenteral administration.

Details for Patent 8,545,893

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	01/16/1978		2030-03-08
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172	11/13/1987		2030-03-08
Genentech, Inc.	CATHFLO ACTIVASE	alteplase	For Injection	103172	09/04/2001		2030-03-08
Chiesi Usa, Inc.	RETAVASE	reteplase	For Injection	103786	10/30/1996		2030-03-08
Genentech, Inc.	TNKASE	tenecteplase	For Injection	103909	06/02/2000		2030-03-08