Aggregate-free urate oxidase for preparation of...

Chemistry: molecular biology and microbiology – Enzyme – proenzyme; compositions thereof; process for... – Oxidoreductase

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C435S191000, C435S440000, C424S094400, C530S350000

Reexamination Certificate

active

07927852

ABSTRACT:
A naturally occurring or recombinant protein, especially a mutein of porcine urate oxidase (uricase), that is essentially free of large aggregates can be rendered substantially non-immunogenic by conjugation with a sufficiently small number of strands of polymer such that the bioactivity of the protein is essentially retained in the conjugate. Such conjugates are unusually well suited for treatment of chronic conditions because they are less likely to induce the formation of antibodies and/or accelerated clearance than are similar conjugates prepared from protein preparations containing traces of large aggregates.

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: 7723089 (2010-05-01), Williams 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: 2008/0031864 (2008-02-01), Williams 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: 62-55079 (1987-03-01), None
patent: 03-148298 (1991-06-01), None
patent: 09-154581 (1997-06-01), None
patent: WO 94/19007 (1994-09-01), 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 01/59078 (2001-08-01), None
Patent Abstract of Japan, English language abstract of JP 55-135590 A (Document FP11), 1990.
Francis, G.E., et al., “PEGylation of cytokines and other therapeutic proteins and peptides: the importance of biological optimisation of coupling techniques,”Int. J. Hematology 68:1-18, Elsevier Science Ireland Ltd. (1998).
Kral, L.G., et al., “Cloning a cDNA forDrosophila melanogasterurate oxidase,”Gene 45:131-137, 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,” Ardis. Biochem. Biophys. 201:185-193, Academic Press, Inc. (1980).
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 (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 (1981).
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. (1989).
Alvares, K., et al., “Rat urate oxidase produced by recombinant baculovirus expression: Formation of peroxisome crystallized core-like structures,”Proc. Natl. Acad. Sci. USA 89:4908-4912, National Academy of Sciences (1992).
Braun, A. and Alsenz, J., “Development and Use of Enzyme-Linked Immunosorbent Assays (ELISA) for the Detection of Protein Aggregates in Interferon-Alpha (IFN-α) Formulations,”Pharm. Res. 14:1394-1400, Plenum Publishing Corporation (Oct. 1997).
Braun, A., et al., “Protein Aggregates Seem to Play a Key Role Among the Parameters Influencing the Antigenicity of Interferon Alpha (IFM-α) in Normal and Transgenic Mice,”Pharm. Res. 14:1472-1478, Plenum Publishing Corporation (Oct. 1997).
Burnham, N.L., “Polymers for delivering peptides and proteins,”Am. J. Hosp. Pharm. 51:210-218, American Society of Hospital Pharmacists, Inc. (1994).
Caliceti, P., et al., “Biopharmaceutical Properties of Uricase Conjugated to Neutral and Amphiphilic Polymers,”Bioconjugate Chem. 10:638-646, American Chemical Society (Jul.-Aug. 1999).
Chen, R.H.-L., et al., “Properties of Two Urate Oxidases Modified by the Covalent Attachment of Poly(Ethylene Glycol),”Biochim. Biophys. Acta 660:293-298, Elsevier/North Holland Biomedical Press (1981).
Chua, C.C., et al., “Use of Polyethylene Glycol-Modified Uricase (PEG-Uricase) to Treat Hyperuricemia in a Patient with Non-Hodgkin Lymphoma,”Ann. Intern. Med. 109:114-117, American College of Physicians (1988).
Colloc'h, N., et al., “Crystal Structure of the protein drug urate oxidase-inhibitor complex at 2.05 Å resolution,”Nature Struct. Biol. 4:947-952, Nature Publishing Company (Nov. 1997).
Conley, T.G. and Priest, D.G., “Thermodynamics and Stoicheiometry of the Binding of Substrate Analogues to Uricase,”Biochem. J. 187:727-732, The Biochemical Society (1980).
Davis, F.F., et al., “Enzyme-Polyethylene Glycol Adducts: Modified Enzymes with Unique Properties,” in:Enzyme Engineering, vol. 4, Braun, G.B., 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 (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 (1981).
Unverified English language partial translation of Donadio, D., et al., “Anaphylaxis-like manifestations after intravenous injection of urate oxidase in an asthmatic child with acute leukemia,”La Nouv. Presse Med. 10:711-712, Masson (1981) (Document NPL15).
Fam, A.G., “Strategies and Controversies in the Treatment of Gout and Hyperuricaemia,”Ballière's Clinical Rheumatology 4:177-192, Ballière Tindall (1990).
Fridovich, I., “The Competitive Inhibition of Uricase by Oxonate and by Related Derivatives ofs-Triazines,”J. Biol. Chem. 240:2491-2494, American Society for Biochemistry and Molecular Biology (1965).
Fuertges, F., and Abuchowski, A., “The Clinical Efficacy of Poly(Ethylene Glycol)-Modified Proteins,”J. Control. Release 11:139-148, Elsevier Science (1990).
Fujita, T., et al., “Tissue Distribution of111In-Labeled Uricase Conjugated with Charged Dextrans and Polyethylene Glycol,”J. Pharmacobio-Dyn. 14:623-629, Pharmaceutical Society of Japan (1991).
Greenberg, M.L. and Hershfield, M.S., “A Radiochemical-High-Performance Liquid Chromatographic Assay for Urate Oxidase in Human Plasma,”Anal. Biochem. 176:290-293, Academic Press, Inc. (1989).
Hande, K.R., et al., “Severe Allopurinol Toxicity. Description and Guidelines for Prevention in Patients with Renal Insufficiency,”Am. J. Med. 76:47-56, Excerpta Medica (1984).
Hedlund, L.W., et al., “Magnetic Resonance Microscopy of Toxic Renal Injury Induced b

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Aggregate-free urate oxidase for preparation of... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Aggregate-free urate oxidase for preparation of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Aggregate-free urate oxidase for preparation of... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-2662020

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.