PEG-urate oxidase conjugates and use thereof

Details PEG-urate oxidase conjugates and use thereof PEG-urate oxidase conjugates and use thereof

2011-04-19

2011-04-19

Saidha, Tekchand (Department: 1652)

Drug, bio-affecting and body treating compositions

Enzyme or coenzyme containing

Oxidoreductases

C424S094300, C435S181000, C435S188000, C435S189000, C435S191000

Reexamination Certificate

active

07927589

ABSTRACT:
A naturally occurring or recombinant urate oxidase (uricase) covalently coupled to poly(ethylene glycol) or poly(ethylene oxide) (both referred to as PEG), wherein an average of 2 to 10 strands of PEG are conjugated to each uricase subunit and the PEG has an average molecular weight between about 5 kDa and 100 kDa. The resulting PEG-uricase conjugates are substantially non-immunogenic and retain at least 75% of the uricolytic activity of the unmodified enzyme.

REFERENCES:
patent: 3616231 (1971-10-01), Bergmeyer et al.
patent: 4179337 (1979-12-01), Davis et al.
patent: 4460683 (1984-07-01), Gloger et al.
patent: 4766106 (1988-08-01), Katre et al.
patent: 4847079 (1989-07-01), Kwan
patent: 4847325 (1989-07-01), Shadle et al.
patent: 4917888 (1990-04-01), Katre et al.
patent: 5122614 (1992-06-01), Zalipsky
patent: 5283317 (1994-02-01), Saifer et al.
patent: 5286637 (1994-02-01), Veronese et al.
patent: 5382518 (1995-01-01), Caput et al.
patent: 5428128 (1995-06-01), Mensi-Fattohi et al.
patent: 5458135 (1995-10-01), Patton et al.
patent: 5468478 (1995-11-01), Saifer et al.
patent: 5541098 (1996-07-01), Caput et al.
patent: 5612460 (1997-03-01), Zalipsky
patent: 5643575 (1997-07-01), Martinez et al.
patent: 5653974 (1997-08-01), Hung et al.
patent: 5711944 (1998-01-01), Gilbert et al.
patent: 5762923 (1998-06-01), Gross et al.
patent: 5811096 (1998-09-01), Aleman et al.
patent: 5824784 (1998-10-01), Kinstler et al.
patent: 5880255 (1999-03-01), Delgado et al.
patent: 5919455 (1999-07-01), Greenwald et al.
patent: 5932462 (1999-08-01), Harris et al.
patent: 5955336 (1999-09-01), Shigyo et al.
patent: 6201110 (2001-03-01), Olsen et al.
patent: 6576235 (2003-06-01), Williams et al.
patent: 6783965 (2004-08-01), Sherman et al.
patent: 6913915 (2005-07-01), Ensor et al.
patent: 2002/0010319 (2002-01-01), Ansaldi et al.
patent: 2003/0166249 (2003-09-01), Williams et al.
patent: 2005/0014240 (2005-01-01), Sherman et al.
patent: 2008/0057048 (2008-03-01), Sherman et al.
patent: 279 486 (1990-06-01), None
patent: 0 043 980 (1982-01-01), None
patent: 55-99189 (1980-07-01), None
patent: 55-135590 (1980-10-01), None
patent: 57-192435 (1982-11-01), None
patent: 62-55079 (1987-03-01), None
patent: 03-148298 (1991-06-01), None
patent: 09-154581 (1997-06-01), None
patent: 09154581 (1997-06-01), None
patent: WO 87/00056 (1987-01-01), None
patent: WO 92/16221 (1992-10-01), None
patent: WO 94/19007 (1994-09-01), None
patent: WO 94/19007 (1994-09-01), None
patent: WO 94/23740 (1994-10-01), None
patent: WO 98/31383 (1998-07-01), None
patent: WO 00/07629 (2000-02-01), None
patent: WO 00/08196 (2000-02-01), None
patent: WO 00/08196 (2000-02-01), None
patent: WO 01/59078 (2001-08-01), None
Chen et al. BBA 660: (1981): 293-298).
Tsuji, J.-I., et al., “Studies on Antigenicity of the Polyethylene Glycol (PEG)-Modified Uricase,”Int. J. Immunopharmac. 7:725-730, Elsevier Science (1985).
European Examination Report for European Application No. 01 923 265.1, mailed Dec. 13, 2007, European Patent Office, Munich, DE.
Francis, G.E., et al., “PEGylation of cytokines and other therapeutic proteins and peptides: the importance of biological optimisation of coupling techniques,”Int. J. Hematology68:1-18, Elsevier Science Ireland Ltd. (1998).
Kral, L.G., et al., “Cloning a cDNA forDrosophila melanogasterurate oxidase,”Gene45:131-137, Elsevier Science Publishers B.V.(1986).
Wang, L.-W.C., and Marzluf, G.A., “Purification and Characterization of Uricase, a Nitrogen-Regulated Enzyme, fromNeurospora crassa,” Archs. Biochem. Biophys. 201:185-193, Academic Press, Inc. (1980).
Chinese Second Office Action for Chinese Application No. 01807750.1, issued Mar. 21, 2008, Chinese Patent Office, Beijing, China.
Montalbini, P., et al., “Isolation and characterization of uricase from bean leaves and its comparison with uredospore enzymes,”Plant Sci. 147:139-147, Elsevier Science Ireland Ltd. (May 1999).
Abuchowski, A., et al., “Effect of Covalent Attachment of Polyethylene Glycol On Immunogenicity and Circulating Life of Bovine Liver Catalase,”J. Biol. Chem. 252:3582-3586, American Society for Biochemistry and Molecular Biology, United States (1977).
Abuchowski, A., et al., “Reduction of Plasma Urate Levels in the Cockerel with Polyethylene Glycol-Uricase,”J. Pharmacol. Exp. Ther. 219:352-354, The American Society for Pharmacology and Experimental Therapeutics, United States (1981).
Alvares, K., et al., “Rat urate oxidase produced by recombinant baculovirus expression: formation of peroxisome crystalloid core-like structures,”Proc. Natl. Acad. Sci. USA89:4908-4912, National Academy of Sciences, United States (1992).
Alvares, K., et al., “The Nucleotide Sequence of a Full Length cDNA Clone Encoding Rat Liver Urate Oxidase,”Biochem. Biophys. Res. Commun. 158:991-995, Academic Press, Inc., United States (1989).
Bossavy, J., et al., “Comparison of the Antithrombotic Effect of PEG-Hirudin and Heparin in a Human Ex Vivo Model of Arterial Thrombosis,”Arterioscler. Thromb. Vasc. Biol. 19:1348-1353, American Heart Association, United States (1999).
Braun, A. and Alsenz, J., “Development and Use of Enzyme-Linked Immunosorbent Assays (ELISA) for the Detection of Protein Aggregates in Interfon-Alpha (IFN-α) Formulations,”Pharm. Res. 14:1394-1400, Plenum Publishing Corporation, United States (1997).
Braun, A., et al., “Protein Aggregates Seem to Play a Key Role Among the Parameters Influencing the Antigenicity of Interferon Alpha(IFN-α) in Normal and Transgenic Mice,”Pharm. Res. 14:1472-1478, Plenum Publishing Corporation, United States (1997).
Burnham, N., “Polymers for delivering peptides and proteins,”Am. J. Hosp. Pharm. 51: 210-218, American Society of Hospital Pharmacists, Inc., United States (1994).
Caliceti, P., et al., “Biopharmaceutical properties of uricase conjugated to neutral and amphiphilic polymer,”Bioconjugate Chem. 10:638-646, American Chemical Society, United States (1999).
Chua, C., et al., “Use of Polyethylene Glycol-Modified Uricase (PEG-Uricase) to Treat Hyperuricemia in a Patient with Non-Hodgkin Lymphoma,”Ann. Intern. Med. 109:114117, American College of Physicians, United States (1988).
Clark, R., et at., “Long-acting Growth Hormone Produced by Conjugation with Polyethylene Glycol,”J. Biol. Chem. 271:21969-21977, The American Society of Biochemistry and Molecular Biology, Inc., United States (1996).
Colloc'h, N., et al., “Crystal Structure of the protein drug urate oxidase-inhibitor complex at 2.05 Ø resolution,”Nature Struct. Biol. 4:947-952, Nature Publishing Group, United Kingdom (1997).
Conley, T. and Priest, D., “Thermodynamics and Stoicheiometry of the Binding of Substrate Analogues to Uricase,”Biochem. J. 187:727-732, The Biochemical Society, United Kingdom (1980).
Davis, F., et al., “Enzyme-Polyethylene Glycol Adducts: Modified Enzymes with Unique Properties,” inEnzyme Engineering, vol. 4, Braun, G., et al., eds, Plenum Press, New York, pp. 169-173 (1978).
Davis, S., et al., “Hypouricaemic Effect of Polyethyleneglycol Modified Urate Oxidase,”Lancet2:281-283, Lancet Publishing Group, United States (1981).
Donadio, D., et al., “Manifestation de type anaphylactique après injection intra-veineuse d'urate-oxydase chez un enfant asthmatique atteint de leucémie aiguë,”La Nouv. Presse Med. 10:711-712, Masson, France (1981).
Fam, A., “Strategies and Controversies in the Treatment of Gout and Hyperuricaemia,”Ballière's Clinical Rheumatology4:177-192, Elsevier, Ltd., United Kingdom (1990).
Fridovich, I., “The Competitive Inhibition of Uricase by Oxonate and by Related Derivatives of s-Triazines,”J. Biol. Chem. 240:2491-2494, American Society for Biochemistry and Molecular Biology, United States (1965).
Fuertges, F., and Abuchowski, A., “The Clinical Efficacy of Poly

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