Claims for Patent: 7,884,068

Summary for Patent: 7,884,068

Title:	Albumin-based colloid composition having at least one protected thiol region, methods of making, and methods of use
Abstract:	A composition comprising an albumin-based colloid composition having at least one protected thiol region, method of making the same, and method for use, including treating hypovolemic conditions such as capillary leak syndrome and shock, are disclosed.
Inventor(s):	Assaly; Ragheb A. (Sylvania, OH), Dignam; J. David (Perrysburg, OH), Shapiro; Joseph I. (Toledo, OH)
Assignee:
Application Number:	10/985,798
Patent Claims:	1. A method for augmenting hydrophilic properties and increasing half-life of at least one albumin protein of interest in serum and decreasing the immunogenicity of at least one albumin protein comprising administering to a patient in need thereof, a composition comprising a polyethylene glycol-albumin-based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin based colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 2. A method for maintaining vascular volume in a patient in need thereof, comprising administering a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 3. A method for treating hemorrhagic shock in a patient in need thereof, comprising administering a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 4. A method for lowering a transfusion trigger to levels below 7 g/dl whereby oxygen delivery to peripheral tissues is maintained at lower hemoglobin level for a longer time prior to blood transfusion in a patient in need thereof, comprising administering a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 5. A method for maintaining an oncotic gradient that reduces extravasation of fluid into the tissue interstitial space in a patient in need thereof, comprising administering a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 6. A method for increasing glutathione and increasing GSH/GSSG in a patient in need thereof, comprising administering a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 7. The method of claim 1 wherein the composition is capable of being lyophilized, rehydrated, restored and reconstituted due to sepsis, shock, burn, trauma, surgery, predisposition to capillary leak, hyperviscosity states, hypoalbuminemia, leukopheresis, nutritional albumin deficiency, nephrotic syndrome, liver failure or anoxia. 8. The method of claim 1, wherein the PEG-Alb.sub.Cys-34 has an ability to bind ligands. 9. The method of claim 8, wherein the ligands comprise sodium ions, fatty acids, bilirubin and therapeutic drugs. 10. An in vivo method of treating hypovolemic conditions in a patient in danger of developing the hypovolemic conditions and/or multiorgan dysfunction comprising administering a therapeutic amount of a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons. 11. A method for the pretreatment of mammalian tissue injury from at least one hypovolemic condition comprising the administration of a therapeutic amount to a mammal of a composition comprising a polyethylene glycol-albumin based colloid composition having at least one protected thiol region wherein the composition comprises PEG-Alb.sub.Cys-34 having a large hydrodynamic radius with Cys-34 preserved as a thiol, wherein the polyethylene glycol-albumin base colloid composition, has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries and wherein the albumin is human albumin or bovine serum albumin; and wherein the polyethylene glycol-albumin based colloid composition has an average molecular weight of at least 128,000 daltons, the composition being incapable of leaking through the mammal's capillaries and being present in an amount sufficient to protect said tissue from injury. 12. The method of claim 11, where the injury is due to sepsis, shock, burn, trauma, surgery, predisposition to capillary leak, hyperviscosity states, hypoalbuminemia, leukopheresis, nutritional albumin deficiency, nephritic syndrome, liver failure, and/or anoxia.

Details for Patent 7,884,068

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2040-01-28
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2040-01-28
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2040-01-28
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2040-01-28
Csl Behring Llc	ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5	albumin (human)	Injection	103955	03/17/2000		2040-01-28