US2014194593A1PendingUtilityA1

Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use

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Assignee: GAD ALEXANDERPriority: Sep 25, 1998Filed: Jan 31, 2013Published: Jul 10, 2014
Est. expirySep 25, 2018(expired)· nominal 20-yr term from priority
Inventors:Alexander GadDora Lis
A61K 38/02C07K 14/001G01N 2800/285G01N 33/502C07K 5/1019Y10T436/105831G01N 33/6848A61L 27/22G01N 33/6842C07K 7/06A61K 38/2026G01N 33/6803G01N 33/68G01N 33/564Y10T436/10A61K 38/2066G01N 33/6812C07K 16/44G01N 33/5008C07K 7/08G01N 33/505C07K 14/00A61K 38/215A61K 38/16
63
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Claims

Abstract

The present invention provides processes for determining the molecular weight of glatiramer acetate and other copolymers. The present invention further provides a plurality of molecular weight markers for determining the molecular weight of glatiramer acetate and other copolymers which display linear relationships between molar ellipticity and molecular weight, and between retention time and the log of the molecular weight. The molecular weight markers also optimally demonstrate biological activity similar to glatiramer acetate or corresponding copolymers and can be used for treating or preventing various immune diseases. In addition, the subject invention provides pharmaceutical compositions for the treatment of immune diseases comprising a polypeptide having an identified molecular weight and an amino acid composition corresponding to glatiramer acetate or a terpolymer.

Claims

exact text as granted — not AI-modified
1 . A polypeptide for determining the molecular weight of a copolymer, said polypeptide having an identified molecular weight and an amino acid composition corresponding to said copolymer, wherein the identified molecular weight is between about 2,000 daltons and about 40,000 daltons. 
     
     
         2 - 3 . (canceled) 
     
     
         4 . The polypeptide of  claim 1  wherein the copolymer is glatiramer acetate. 
     
     
         5 . (canceled) 
     
     
         6 . The polypeptide of  claim 1  wherein said copolymer comprises amino acids alanine, glutamic acid, tyrosine and lysine, and wherein: said alanine is present in a molar fraction of about 0.38 to about 0.50; said glutamic acid is present in a molar fraction of about 0.13 to about 0.15; said tyrosine is present in a molar fraction of about 0.08 to about 0.10; and said lysine is present in a molar fraction of about 0.3 to about 0.4. 
     
     
         7 . The polypeptide of  claim 1  wherein said copolymer comprises amino acids alanine, glutamic acid, tyrosine and lysine, and wherein: said alanine is present in a molar fraction of about 0.42 to 0.45; said glutamic acid is present in a molar fraction of about 0.13 to about 0.15; said tyrosine is present in a molar fraction of about 0.08 to about 0.10; and said lysine is present in a molar of about 0.3 to about 0.4. 
     
     
         8 - 9 . (canceled) 
     
     
         10 . The polypeptide of  claim 6  which is selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 or SEQ ID NO: 7. 
     
     
         11 - 19 . (canceled) 
     
     
         20 . A plurality of polypeptides for determining the molecular weight of a copolymer on a molecular weight sizing column, which comprises two to about ten polypeptides, each polypeptide having an identified molecular weight and an amino acid composition corresponding to said copolymer and wherein an approximately linear relationship exists between the retention time of said polypeptides on said column and the log of the molecular weight of said polypeptides. 
     
     
         21 . The plurality of polypeptides of  claim 20  wherein the identified molecular weight is between about 2,000 daltons and about 40,000 daltons. 
     
     
         22 . The plurality of polypeptides of  claim 20  wherein the copolymer is glatiramer acetate. 
     
     
         23 . (canceled) 
     
     
         24 . The plurality of polypeptides of  claim 20  wherein said copolymer comprises amino acids alanine, glutamic acid, tyrosine and lysine, and wherein: said alanine is present in a molar fraction of about 0.38 to about 0.50; glutamic acid is present in a molar fraction of about 0.13 to about 0.15; said tyrosine is present in a molar fraction of about 0.08 to 0.10; and said lysine is a molar fraction of about 0.3 to about 0.4. 
     
     
         25 . The plurality of polypeptides of  claim 20  wherein said copolymer comprises amino acids alanine, glutamic acid, tyrosine and lysine, and wherein: said alanine is present in a molar fraction of about 0.42 to about 0.45; said glutamic acid is present in a molar fraction of about 0.13 to about 0.15; said tyrosine is present in a molar fraction of about 0.08 to about 0.10; and said lysine is present in a molar fraction of about 0.3 to about 0.4. 
     
     
         26 - 29 . (canceled) 
     
     
         30 . The plurality of polypeptides of  claim 20  which comprises one or more polypeptides selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 or SEQ ID NO: 7. 
     
     
         31 - 33 . (canceled) 
     
     
         34 . A kit comprising the plurality of polypeptides of  claim 20 . 
     
     
         35 - 103 . (canceled) 
     
     
         104 . A polypeptide for calibrating a molecular weight discrimination system for measuring the molecular weight of a copolymer said polypeptide having an identified molecular weight and a composition corresponding to said copolymer. 
     
     
         105 . The polypeptide of  claim 104  wherein the identified molecular weight is between about 2,000 daltons and about 40,000 daltons. 
     
     
         106 . (canceled) 
     
     
         107 . The polypeptide of  claim 104  wherein the copolymer is glatiramer acetate. 
     
     
         108 . (canceled) 
     
     
         109 . The polypeptide of  claim 104  wherein said copolymer comprises amino acids alanine, glutamic acid, tyrosine and lysine, and wherein: said alanine is present in a molar fraction of about 0.38 to about 0.50; said glutamic acid is present in a molar fraction of about 0.13 to about 0.15; said tyrosine is present in a molar fraction of about 0.08 to about 0.10; and said lysine is present in a molar fraction of about 0.3 to about 0.4. 
     
     
         110 . The polypeptide of  claim 104  wherein said copolymer comprises amino acids alanine, glutamic acid, tyrosine and lysine, and wherein: said alanine is present in a molar fraction of about 0.42 to about 0.45; said glutamic acid is present in a molar fraction of about 0.13 to about 0.15; said tyrosine is present in a molar fraction of about 0.08 to about 0.10; and said lysine is present in a molar fraction of about 0.3 to about 0.4. 
     
     
         111 - 112 . (canceled) 
     
     
         113 . The polypeptide of  claim 109  which is selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6 or SEQ ID NO: 7. 
     
     
         114 - 119 . (canceled) 
     
     
         120 . The polypeptide of  claim 104  wherein the molecular weight of the copolymer is determined with a molecular size discrimination system and wherein the molecular size discrimination system is a molecular weight sizing column. 
     
     
         121 . (canceled) 
     
     
         122 . The polypeptide of  claim 120  wherein said molecular weight sizing column is selected from the group consisting or a TSK column, a Sephadex column, a Sepharose column, and a Superose column.

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