Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing
Reexamination Certificate
2005-02-22
2005-02-22
Rao, Manjunath N. (Department: 1652)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
C435S004000, C435S006120, C435S069100, C435S183000, C435S252300, C435S320100, C435S200000, C536S023200, C536S023700
Reexamination Certificate
active
06858206
ABSTRACT:
The present invention provides a formulation comprising a pharmaceutical composition comprising a human recombinant α-L-iduronidase or biologically active or muteins thereof with a purity of greater than 99%, or in combination with a pharmaceutically acceptable carrier. The present invention further provides methods to treat certain genetic disorders including α-L-iduronidase deficiency and mucopolysaccharidosis I (MPS 1) by administering said formulation.
REFERENCES:
patent: 3472931 (1969-10-01), Stoughton
patent: 3891757 (1975-06-01), Higuchi
patent: 5270051 (1993-12-01), Harris
patent: 6149909 (2000-11-01), Scott et al.
patent: 6238662 (2001-05-01), Scott et al.
patent: 1001949 (1965-08-01), None
patent: WO 9310244 (1993-05-01), None
patent: WO 9710353 (1997-03-01), None
patent: WO 9951724 (1999-10-01), None
patent: WO 9958691 (1999-11-01), None
Franchimont, et al., “Induction of Inflammation by Immunological Reactions”,Agents and Actions, 6(1-3):2-4, 1976.
Anson, D. S., et al., “Correction of Human Mucopolysaccharidosis Type—VI Fibroblasts with RecombinantN-Acetylgalactosamine-4-Sulphatase,”Biochem J.—284:789-794 (1992).
Barton, R. W., et al., “The Hurler Corrective Factor,”J. Biol. Chem.—246(24):7773-7779 (1971).
Bielicki, J., et al., “Recombinant Human Iduronate-2-Sulphatase: Correction of Mucopolysaccharidosis-Type II Fibroblasts and Characterization of the Purified Enzyme,”Biochem. J.—289:241-246 (1993).
Clements, et al., “Human alpha-L-iduronidase 1. Purification, monoclonal antibody production, native and subunit molecular mass”,European Journal of Biochemistry, 152(1):43-49 (1994).
Friedman, T., “Progress Toward Human Gene Therapy, ”Science—244:1275-1281 (1989).
Hoogerbrugge, P.M., et al., “Allogeneic Bone Marrow Transplantation for Lysosomal Storage Diseases,”Lancet—345:1398 (1995).
Ioannou, Y.A., et al., “Overexpression of Humanα-Galactosidase A Results in Its Intracellular Aggregation, Crystallization in Lysosomes, and Selective Secretion,”J. Cell Biol.—119(5):1137-1150 (1992).
Kakkis, et al., “Enzyme-replacement therapy in mucopolysaccharidosis I., ”New England Journal of Medicine, 344(3):182-188 (2001).
Kakkis, E., et al., “Strong Transcriptional Activation of Translocated C-Myc Genes Occurs Without a Strong Nearby Enhancer or Promoter,”Nucleic Acids Res.—16(1):77-96 (1988).
Ledley, F.D., “Clinical Application of Somatic Gene Therapy in Inborn Errors of Metabolism,”Inherit. Metab. Dis.—13:597-616 (1990).
Lowry, R.B., et al. “An Update on the Frequency of Mucopolysaccharide Syndromes in British Columbia,”Human Genetics—85:389-390 (1990).
Myerowitz, R., et al., “Maturation of α-L-Iduronidase in Cultured Human Fibroblasts,”J. Biol. Chem.—256(6):3044-3048 (1981).
Moskowitz, S.M., et al., “Cloning and Expression of cDNA Encoding the Human Lysosomal Enzyme, α-L-Iduronidase,”FASEB J.—6:A77 (1992).
Nelson, J., “Incidence of the Mucopolysaccharidoses in Northern Ireland,”Human Genetics—101:355-358 (1997).
Scriver, C.R., Beaudet, A.L., Sly, W.S. and Valle, D. Eds.The Metabolic Basis of Inherited Diseasepp 1565-1587, McGraw Hill, New York (1989).
Shull, R.M., et al., “Enzyme Replacement in a Canine Model of Hurler Syndrome,”Proc. Natl. Acad. Sci., USA—91:12937-12941 (1994).
Stoltzfus, L.J., et al., “Cloning and Characterization of cDNA Encoding Canine α-L-Iduronidase,”J. Biol. Chem.—267(10):6570-6575 (1992).
Taylor, J., et al., “α-L-Iduronidase in Normal and Mucopolysaccharidosis—Type-1 Human Skin Fibroblasts,”Biochem J.—274:263-268 (1991).
Tolstoshev, P., et al., “Gene Expression Using Retroviral Vectors,”Current Opinions Biotech.—1:55-61 (1990).
Tucker, P.W., et al., “Mouse IgA Heavy Chain Gene Sequence: Implications for Evolution of Immunoglobulin Hinge Exons,”Proc. Natl. Acad. Sci. USA—78(12):7684-7688 (1981).
Unger, E.G., et al., “Recombinant α-L-Iduronidase: Characterization of the Purified Enzyme and Correction of Mucopolysaccharidosis Type I Fibroblasts,”Biochem. J.—304:43-49 (1994).
Kakkis, et al., “Long-Term and High-Dose Trials of Enzyme Replacement Therapy in the Canine Model of Mucopolysaccharidosis I”,Biochem. Mol. Med. vol. 58, No. 2, pp. 156-167 (1996).
Neufield, et al., “The Mucopolysaccharidoses”,The Metabolic Basis of Inherited Disease, Scriver, C.R., Beaudet, A. L., Sly, W.S., and Valle, D. Eds. McGraw Hill, New York, pp. 1565-1587 (1989).
Rome, et al., “α-L-Iduronidase for Human Kidney”Methods in Enzymology, vol. 83, pp. 578-582 (1982).
Schuchman, et al., “Human α-L-Iduronidase: Purification and Properties of the High Uptake (Higher Molecular Weight) and the Low Uptake (Processed) Forms”J. Bio. Chem, vol. 259, No. 5, pp. 3132-3140 (1984).
Scott, et al., “Human α-L-Iduronidase: cDNA Isolation and Expression”,Proc. Natl. Acad. Sci. USAvol. 88, pp. 9695-9699, (1991).
Scott, et al., “Multiple Polymorphisms Within the α-L-Iduronidase Gene (IDUA): Implications for a Role in Modification of MPS-I Disease Phenotype”,Hum. Mol. Genet. vol. 2, No. 9, pp. 1471-1473 (1993).
Stolzfus, et al., “Mucopolysaccharidosis I: cloning and characterization of cDNA encoding canine α-L-Iduronidase”,Am. J. Hum. Genet., vol. 47, No. 3, p. A167, (1990).
Clements, et al., “Immunopurification and characterization of human α-L-iduronidase with the use of monoclonal antibodies”,Biochem. J. vol. 259, pp. 199-208 (1989).
Kakkis, et al., “Overexpression of the human lysosomal enzyme α-L-iduronidase in Chinese Hamster Ovary cells”,Prot. Exp. Purif. vol. 5, pp. 225-232 (1994).
Scott, et al., “Chromosomal localization of the human α-L-iduronidase gene (IDUA) to 4p16.3”Am. J. Hum. Genet. vol. 47, pp. 802-807 (1990).
Zhao, et al., “Carbohydrate structures of recombinant human α-L-iduronidase secreted by Chinese Hamster Ovary cells”,J. Biol. Chem.vol. 273, No. 36, pp. 22758-22765 (1997).
“BioMarin and Genzyme Report positive One Year Summary Data For MPS-1 Patients” Sep. 14, 1999.
Marshall & Gerstein & Borun LLP
Rao Manjunath N.
LandOfFree
Methods for treating diseases caused by deficiencies 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 Methods for treating diseases caused by deficiencies of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods for treating diseases caused by deficiencies of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3489934