Claims for Patent: 6,602,989

Summary for Patent: 6,602,989

Title:	Synthesis, characterization, and application of pyridylazo bioconjugates as diagnostic and therapeutic agents
Abstract:	The detection of gallium in biological samples is required due to its role in the diagnosis of tumor and for possible treatment of malignancies. However, the use of purely instrumental techniques is unsuitable for detection of low levels of gallium in biological matrices. New protein conjugates have been synthesized based on 4-(2-pyridylazo) ligands. The conjugates detect gallium in biological matrices using a non antibody-based sandwich assay format. The recovery level is between 97-101.3 with a relative standard deviation of less than 5%. The assay results in a detection limit of 5.times.10.sup.-8 M and a remarkable selectivity for gallium(III) relative to other metals investigated. The new method provides adequate accuracy for gallium applicable for animal physiology and clinical toxicology.
Inventor(s):	Sadik; Omowunmi A. (Vestal, NY), Xu; Hongwu (Binghamton, NY)
Assignee:	The Research Foundation of State University of New York (Albany, NY)
Application Number:	09/573,993
Patent Claims:	1. A protein conjugate gallium (III) complex comprising the reaction product of a) a ((heterocyclyl)azo)orthohydroxyarylene derivative comprising a protein binding functionality wherein the azo linking group is attached ortho to the nitrogen atom of the heterocycle and wherein the hydroxy group on the arylene moiety is in a position ortho to the site of attachment of the azo linking group and b) a protein the conjugate being complexed with gallium (III). 2. The complex of claim 1 wherein the protein binding functionality is selected from the group consisting of hydroxy, amino, sulfhydryl, carboxy, and reactive derivatives thereof. 3. The complex of claim 1 wherein the ((heterocyclyl)azo)orthohydroxyarylene derivative is 4-(2-pyridylazo)resorcinol. 4. The complex of claim 1 wherein the ((heterocyclyl)azo)orthohydroxyarylene derivative is 2-hydroxy-5-methyl-3-(2-pyridylazo)benzoic acid. 5. The complex of claim 1 wherein the protein is selected from the group consisting of antibodies, antibody fragments, ovalbumin, bovine serum albumin, human serum albumin, horseradish peroxidase, and alkaline phosphatase. 6. The complex of claim 1 wherein the complex is immobilized on a substrate. 7. The complex of claim 6 wherein said substrate comprises polysaccharides or cellulosics.

Details for Patent 6,602,989

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