Pegylated factor VIII

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

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C530S380000, C530S381000, C424S530000

Reexamination Certificate

active

08053561

ABSTRACT:
The invention is a proteinaceous construct comprising a Factor VIII molecule having at least a portion of the B domain intact, which is conjugated to a water-soluble polymer such as polyethylene glycol having a molecular weight of greater than 10,000 Daltons. The construct has a biological activity of at least 80% of the biological activity of native Factor VIII, and the in vivo half-life of the construct is increased by at least 1.5 fold as compared to the in vivo half-life of native factor FVIII.

REFERENCES:
patent: 4179337 (1979-12-01), Davis et al.
patent: 4356170 (1982-10-01), Jennings et al.
patent: 4757006 (1988-07-01), Toole, Jr. et al.
patent: 4877608 (1989-10-01), Lee et al.
patent: 4965199 (1990-10-01), Capon et al.
patent: 4970300 (1990-11-01), Fulton et al.
patent: 5122614 (1992-06-01), Zalipsky
patent: 5153265 (1992-10-01), Shadle et al.
patent: 5198349 (1993-03-01), Kaufman
patent: 5198493 (1993-03-01), Holmberg et al.
patent: 5250421 (1993-10-01), Kaufman et al.
patent: 5298643 (1994-03-01), Greenwald
patent: 5328694 (1994-07-01), Schwinn
patent: 5470954 (1995-11-01), Neslund et al.
patent: 5492821 (1996-02-01), Callstrom et al.
patent: 5539063 (1996-07-01), Hakimi et al.
patent: 5565427 (1996-10-01), Freudenberg
patent: 5605884 (1997-02-01), Lee et al.
patent: 5618788 (1997-04-01), Capon et al.
patent: 5621039 (1997-04-01), Hallahan et al.
patent: 5733873 (1998-03-01), Osterberg et al.
patent: 5846951 (1998-12-01), Gregoriadis
patent: 5919766 (1999-07-01), Osterberg et al.
patent: 5969040 (1999-10-01), Hallahan et al.
patent: 6005077 (1999-12-01), Schwarz et al.
patent: 6037452 (2000-03-01), Minamino et al.
patent: 6048720 (2000-04-01), Dalborg et al.
patent: 6183738 (2001-02-01), Clark
patent: 6379933 (2002-04-01), Johnson et al.
patent: 6455639 (2002-09-01), Yasukohchi et al.
patent: 6566506 (2003-05-01), Greenwald et al.
patent: 6586398 (2003-07-01), Kinstler et al.
patent: 6586573 (2003-07-01), Besman et al.
patent: 6692931 (2004-02-01), Reutter et al.
patent: 6743908 (2004-06-01), Filpula et al.
patent: 6806063 (2004-10-01), Pedersen et al.
patent: 6864350 (2005-03-01), Harris
patent: 6872393 (2005-03-01), Whitlow et al.
patent: 6913915 (2005-07-01), Ensor et al.
patent: 7118737 (2006-10-01), Kochendoerfer et al.
patent: 7199223 (2007-04-01), Bossard et al.
patent: 7230081 (2007-06-01), Jensen et al.
patent: 7338788 (2008-03-01), Pedersen et al.
patent: 7645860 (2010-01-01), Turecek et al.
patent: 2003/0143596 (2003-07-01), Bentley et al.
patent: 2004/0132640 (2004-07-01), DeFrees et al.
patent: 2004/0247634 (2004-12-01), Martinod et al.
patent: 2005/0106658 (2005-05-01), Defrees
patent: 2006/0160948 (2006-07-01), Scheiflinger et al.
patent: 2006/0276634 (2006-12-01), Nakamura et al.
patent: 2007/0244301 (2007-10-01), Siekmann et al.
patent: 2009/0076237 (2009-03-01), Turecek et al.
patent: 0306968 (1989-03-01), None
patent: 0605963 (1994-07-01), None
patent: 0774261 (1997-05-01), None
patent: 0784632 (1997-07-01), None
patent: 0977584 (2000-02-01), None
patent: 1258497 (2002-11-01), None
patent: 1260582 (2002-11-01), None
patent: WO-86/06096 (1986-10-01), None
patent: WO-91/09122 (1991-06-01), None
patent: WO-92/16555 (1992-10-01), None
patent: WO-93/00357 (1993-01-01), None
patent: WO-94/05332 (1994-03-01), None
patent: WO-94/15625 (1994-07-01), None
patent: WO-94/15626 (1994-07-01), None
patent: WO-94/29370 (1994-12-01), None
patent: WO-96/40731 (1996-12-01), None
patent: WO-97/11957 (1997-04-01), None
patent: WO-97/19701 (1997-06-01), None
patent: WO-98/25969 (1998-06-01), None
patent: WO-98/38219 (1998-09-01), None
patent: WO-00/23114 (2000-04-01), None
patent: WO-00/48635 (2000-08-01), None
patent: WO-00/49047 (2000-08-01), None
patent: WO-01/05434 (2001-01-01), None
patent: WO-01/37893 (2001-05-01), None
patent: WO-03/040211 (2003-05-01), None
patent: WO-2004/075923 (2004-09-01), None
patent: WO-2004/081053 (2004-09-01), None
patent: WO-2004/089280 (2004-10-01), None
patent: WO-2005/032581 (2005-04-01), None
patent: WO-2005/058366 (2005-06-01), None
patent: WO-2006/071801 (2006-07-01), None
patent: WO-2008/025856 (2008-03-01), None
patent: WO-2008/074032 (2008-06-01), None
Abuchowski et al., Cancer therapy with chemically modified enzymes. I. Antitumor properties of polyethylene glycol-asparaginase conjugates.Cancer Biochem. Biophys. 7: 175-86 (1984).
Avigad et al., The D-galactose oxidase ofPolyporus circinatus, J. Biol. Chem., 237:2736-43 (1962).
Baxter announces collaborations to develop longer acting forms of blood clotting factors, Baxter News (online), Sep. 29, 2005.
Bi et al., Targeted disruption of the mouse factor VIII gene produces a model of haemophilia A,Nat. Genet., 10:119-21 (1995).
Blood coagulation factor derivatives with side chain of amino acids moiety bound via coupling agent to poly:alkylene glycol[abstract], Derwent, Sep. 29, 1984, (JP 01 742043, Nippon Chemiphar Co., Mar. 15, 1993).
Brown et al., An ELISA test for the binding of von Willebrand antigen to collagen,Thromb. Res., 43:303-11 (1986).
Caliceti et al., Pharmacokinetics of pegylated interferons: What is misleading?Digest. Liver Dis. 36(Suppl. 3): S334-9 (2004).
Denis et al., A mouse model of severe von Willebrand disease: defects in hemostasis and thrombosis,Proc. Natl. Acad. Sci. USA, 95:9524-9 (1998).
DeRomeuf et al., Heparin binding assay of von Willebrand factor (vWF) in plasma milieu—evidence of the importance of the multimerization degree of vWF,Thromb. Haemost., 69:436-40 (1993).
Elodi et al., Kinetics of formation of factor IXa-factor VIII complex on the surface of platelets,Thromb. Res., 21:695-700 (1981).
European Pharmacopoeia (Ph. Eur.) 3rd ed., 2.7.4 (1997).
European Search Report for corresponding European Application No. EP07754130.8, dated May 7, 2009.
Favaloro, Collagen binding assay for von Willebrand factor (VWF:CBA): detection of von Willebrands Disease (VWD), and discrimination of VWD subtypes, depends on collagen source,Thromb. Haemost., 83:127-35 (2000).
Fernandes et al., Polysialylated asparaginase: preparation, activity and pharmacokinetics,Biochim. Biophys. Acta, 1341:26-34 (1997).
Final office action from U.S. Appl. No. 11/317,582, dated Aug. 18, 2009.
Fischer et al., Biochemical and functional characterization of recombinant von Willebrand factor produced on a large scale,Cell Mol. Life Sci., 53:943-50 (1997).
Fischer et al., Structural analysis of recombinant von Willebrand factor produced at industrial scale fermentation of transformed CHO cells co-expressing recombinant furin,FEBS Lett., 375:259-62 (1995).
Fischer et al., Structural analysis of recombinant von Willebrand factor: identification of hetero- and homo-dimers,FEBS Lett., 351:345-8 (1994).
Girma et al., Structure-function relationship of the A1 domain of von Willebrand factor,Thromb. Haemost., 74:156-60 (1995).
Gregoriadis et al., Polysialic acids: potential in drug delivery,FEBS Lett., 315:271-276, 1993.
Gregoriadis et al., Polysialic acids: potential in improving the stability and pharmokinetics of proteins and other therapeutics,CMLS Cell. Mol. Life Sci., 57:1964-1969 (2000).
Gregoriadis et al., Polysialylated proteins: an approach to improving enzyme stability and half-life in the blood circulation,Sciences Techniques et Pratiques STP, 9:61-66, 1999.
Harris et al., Effect of pegylation on pharmaceuticals.Nat Rev. Drug Discovery. 2: 214-21 (2003).
International Search Report and Written Opinion for International Application No. PCT/US2005/046879, mailed Jun. 19, 2007.
International Search Report and Written Opinion for corresponding International Application No. PCT/US2007/007560, mailed Sep. 18, 2007.
International Search Report and Written Opinion for International Application No. PCT/US09/52103, dated Feb. 25, 2010.
Jain et al., Polysialylated insulin: synthesis, characterization and biological activity in vivo,Biochim. Biophys. Acta, 1622:42-49 (2003).
Jain et al., Polysialylation: the natural way to improve the stability and pharmacokinetics of protein and peptide drugs,Drug Delivery Systems&Sciences, 4:3-9 (2004).
Jennings et al., Immunochemistry of groups

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

Pegylated factor VIII does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Pegylated factor VIII, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Pegylated factor VIII will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-4280086

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