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Title:
SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
Document Type and Number:
WIPO Patent Application WO2004078140
Kind Code:
A3
Abstract:
The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGP's), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino­terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated forms of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

Inventors:
BOOKBINDER LOUIS H (US)
KUNDU ANIRBAN (US)
FROST GREGORY I (US)
Application Number:
PCT/US2004/006656
Publication Date:
November 17, 2005
Filing Date:
March 05, 2004
Export Citation:
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Assignee:
HALOZYME INC (US)
BOOKBINDER LOUIS H (US)
KUNDU ANIRBAN (US)
FROST GREGORY I (US)
International Classes:
A01K67/027; A61K31/00; A61K31/7088; A61K38/17; A61K38/47; A61K47/30; A61K47/36; A61K47/48; A61K48/00; A61P9/00; A61P27/02; A61P35/00; A61P43/00; C07H21/04; C07K1/00; C07K16/40; C12N1/20; C12N5/00; C12N9/00; C12N9/24; C12N9/26; C12N11/08; C12N11/10; C12N15/00; C12N15/56; C12P21/02; C12P21/06; A61K; (IPC1-7): C12P21/06; C12N9/00; C12N9/24; C12N1/20; C12N15/00; C07H21/04
Foreign References:
US5721348A1998-02-24
US5854046A1998-12-29
US5958750A1999-09-28
US6057110A2000-05-02
Other References:
CHER G.N. ET AL: "The dual functions of GPI anchored PH-20: hyaluronidase and intracellular signalling", MATRIX BIOL., vol. 20, no. 8, December 2001 (2001-12-01), pages 515 - 525, XP002990038
CHER G.N. ET AL: "The PH-20 protein in cynomolgus macaque spermatozoa:identification of two different forms exhibiting hyaluronidase activity", DEV. BIOL., vol. 175, no. 1, 1996, pages 142 - 153, XP002990039
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