Method of administering porcine B-domainless fVIII

Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Blood proteins or globulins – e.g. – proteoglycans – platelet...

Reexamination Certificate

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C530S350000, C514S002600, C514S012200, C424S009100

Reexamination Certificate

active

07576181

ABSTRACT:
The present invention provides a method of administering porcine B-domainless factor VIII (OBI-1) to a patient having factor VIII deficiency to provide more rapid and effective protection against bleeding episodes, compared to formerly available methods, or to provide more effective protection to such patients during non-bleeding periods. This invention is based on the discovery that the recombinant B-domainless porcine fVIII, termed OBI-1, has greater bioavailability compared to the natural porcine fVIII partially purified from porcine plasma, termed HYATE:C. Therefore, the inventive method employs lower unit doses of OBI-1, including, alternatively, omission of antibody-neutralizing dosage, or has longer intervals between the administration, compared to HYATE:C, to provide equivalent protection in patients having fVIII deficiency. The invention further provides pharmaceutical compositions and kits containing OBI-1 in combination with a pharmaceutically acceptable carrier, that are useful for treating patients in need of fVIII more effectively.

REFERENCES:
patent: 4348384 (1982-09-01), Horikoshi et al.
patent: 4757006 (1988-07-01), Toole
patent: 4868112 (1989-09-01), Toole
patent: 5364771 (1994-11-01), Lollar
patent: 5563045 (1996-10-01), Pittman et al.
patent: 5583209 (1996-12-01), Lollar et al.
patent: 5663060 (1997-09-01), Lollar et al.
patent: 5744446 (1998-04-01), Lollar et al.
patent: 5859204 (1999-01-01), Lollar
patent: 5888974 (1999-03-01), Lollar et al.
patent: 5935935 (1999-08-01), Connelly et al.
patent: 6180371 (2001-01-01), Lollar
patent: 6200560 (2001-03-01), Couto et al.
patent: 6376463 (2002-04-01), Lollar
patent: 6458563 (2002-10-01), Lollar
patent: 6642028 (2003-11-01), Ill et al.
patent: 6759216 (2004-07-01), Lollar
patent: 6770744 (2004-08-01), Lollar
patent: 6818439 (2004-11-01), Jolly et al.
patent: 7012132 (2006-03-01), Lollar
patent: 7033791 (2006-04-01), Lollar
patent: 7122634 (2006-10-01), Lollar
patent: 2004/0249134 (2004-12-01), Lollar
patent: 2005/0009148 (2005-01-01), Lollar
patent: 2005/0118684 (2005-06-01), Li
patent: 2007/0135342 (2007-06-01), Lollar
patent: 2007/0173446 (2007-07-01), Lollar
patent: 0 182 448 (1986-05-01), None
patent: 0 306 968 (1989-03-01), None
patent: WO 91/07438 (1991-05-01), None
patent: WO 93/20093 (1993-10-01), None
patent: WO 94/11503 (1994-05-01), None
patent: WO 95/24427 (1995-09-01), None
patent: WO 97/03191 (1997-01-01), None
patent: WO 97/03193 (1997-01-01), None
patent: WO 99/46274 (1999-09-01), None
patent: WO 00/71141 (2000-11-01), None
patent: 01/68109 (2001-09-01), None
patent: WO 01/68109 (2001-09-01), None
patent: WO 03/080108 (2003-10-01), None
patent: WO 2005/107776 (2005-11-01), None
Amendment Pursuant to 37 C.F.R. 1.312, Corresponding to U.S. Appl. No. 09/523,656, filed Mar. 10, 2000, Transmitted Jun. 25, 2002.
Barrow et al. (2001) “Antigenicity of Putative Phospholipid Membrane-Binding Residues in Factor VIII,”Blood97(1):169-174.
Barrow et al. (Jan. 15, 2000) “Reduction of the Antigenicity of Factor VIII Toward Complex Inhibitory Antibody Plasmas Using Multiply-Substituted Hybrid Human/Porcine Factor VIII Molecules,”Blood95(2):564-568.
Barrow RT, Lollar P (Aug. 2006) “Neutralization of Antifactor VIII Inhibitors by Recombinant Porcine Factor VIII.”J. Thromb. Haemost. 2006. DOI: 10.1111/j.1538-7836.2006.02135.x.
Barrowcliffe, T.W. et al (2002) “Coagulation and Chromogenic Assays of Factor VIII Activity: General Aspects, Standardization, and Recommendations.”Semin. Thromb. Hemost. 28:247-256.
Bihoreau et al. (1991) “Structural and Functional Characterization of VIII-Delta. A New Recombinant Factor VIII Lacking Most of the B-Domain,”Biochem. J. 277:23-31.
Bithell, TC, “The Diagnostic Approach to the Bleeding Disorders”, p. 1302, Chapter 48 in Lee GR, Bithell TC, Foerster J, Athens JW and Lukens JN [eds],Wintrobe's Clinical Hematology, ninth edition, 1993, Lea & Febiger, Malvern, PA.
Chang et al. (1998) “Changing Residue 338 in Human Factor IX from Arginine to Alanine Causes an Increase in Catalytic Activity,”J. Biol. Chem. 273(20):12089-12094.
Church et al. (1984) “Coagulation Factors V and VIII and Ceruloplasmin Constitute a Family of Structurally Related Proteins,”Proc. Nat. Acad. Sci. USA81:6934-6937.
Doehring et al. (2002) “High Level Expression of Recombinant Porcine Coagulation Factor VIII,”J. Biol. Chem. 277(41):38345-38349.
Dominguez et al. (1994) “Gene Walking by Unpredictable Primed PCR,”Nuc. Acids Res. 22:3247-3248.
Eaton et al. (1986) “Construction and Characterization of an Active Factor VIII Variant Lacking the Central One-Third of the Molecule,”Biochem. 25(26):8343-8347.
Fulcher et al. (1985) “Localization of Human Factor FVIII Inhibitor Epitopes to Two Polypeptide Fragments,”Proc. Nat. Acad. Sci. USA82:7728-7732.
Gatti, L. et al [1984] “Use of Porcine Factor VIII in the Management of Seventeen Patients with Factor VIII Antibodies.”Throm. Haemost. 51:379-384.
Gitschier et al. (1984) “Characterization of the Human Factor VIII Gene,”Nature312:326-330.
Hay, C. et al [1995 ] “Porcine Factor VIII Therapy in Patients with Factor VIII Inhibitors.”Inhibitors to Coagulation Factors[L.M. Aledort et al. eds.] Plenum Press, New York, pp. 143-151.
Hay, CRM [2000] “Porcine Factor VIII: Past, Present and Future.”Haematologica85:21-24.
Healy et al. (1996) “The cDNA and Derived Amino Acid Sequence of Porcine Factor VIII,”Blood88:4209-4214.
International Preliminary Report on Patentability, Corresponding to PCT/US05/014760, Completed Nov. 11, 2006.
International Search Report, Corresponding to PCT/US01/05076, Completed May 21, 2001.
International Search Report, Corresponding to PCT/US05/14760. Completed Aug. 17, 2005.
Kasper, C. K. et al (1975) “A More Uniform Measurement of Factor VIII Inhibitors.”Thromb. Diath. Haemorrh. 34:869-872.
Kernoff, PBA [1984] “Porcine Factor VIII: Preparation and Use in Treatment of Inhibitor Patients.”Factor VIII Inhibitors[L.W. Hoyer, ed.] Alan R. Liss, New York, pp. 207-224.
Kessler, CM, et al. (2005) “B-Domain Deleted Recombinant Factor VIII Preparations are Bioequivalent to a Monoclonal Antibody Purified Plasma-Derived Factor VIII Concentrate: A Randomized, Three-Way Crossover Study.”Hemophilia, 11:84.
Lind et al. (1995) “Novel Forms of B-Domain-Deleted Recombinant Factor VIII Molecules: Construction and Biochemical Characterization,”Eur. J. Biochem. 232:19-27.
Lollar et al. (1991) “Structural Basis for the Decreased Procoagulant Activity of Human Factor VIII Compared to the porcine Homolog”J. Biological Chem. 266:12481-12486.
Lollar et al. (1992) “Coagulant Properties of Hybrid Human/Porcine Factor VIII Molecules,”J. Biological Chem. 267:23652-23657.
Lollar et al. (2000) “Mapping Factor VIII Inhibitor Epitopes Using Hybrid Human/Porcine Factor VIII Molecules,”Haematologica85(10s):26-30.
Lubin et al. (1994) Elimination of a Major Inhibitor Epitope in Factor VIIIJ. Biol. Chem. 269:8639-8641.
Meulien et al. (1988) “A New Recombinant Procoagulant Protein Derived from the cDNA Encoding Human Factor VIII,”Prot. Eng. 2:301-306.
Morrison et al. (1993) “Use of Porcine Factor VIII in the Treatment of Patients with Acquired Hemophilia”Blood81:1513-1520.
Ochman et al. (1990) “Inverse Polymerase Chain Reaction,”Nature Biotech. 8:759-760.
Office Action, U.S. Appl. No. 09/523,656, filed Mar. 10, 2000, Mailed on June 1, 2001.
Parker et al. (1991) “Targeted Gene-Walking Polymerase Chain Reaction,”Nuc. Acids Res. 19:3055-3060.
Parker et al. (1991) “The Oligomer Extension ‘Hot Blot’; A Rapid Alternative to Southern Blots for Analyzing Polymerase Chain Reaction Products,”Biotechniques10:94-101.
Parker et al. (2003) “Comparative Immunogenicity of Recombinant B Domain-D

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