US 2006/0189527 A1 · Methods of treating disease with random copolymers

Abstract

The invention relates to novel methods and kits for treating or preventing disease through the administration of random copolymers. The invention also relates to the treatment of autoimmune diseases, such as multiple sclerosis, and to the administration of random copolymers in treatment regimen comprising formulations that are administered at intervals greater than 24 hours, or to sustained release formulations which administer the copolymer over a period greater than 24 hours. The invention further relates to methods for conducting a pharmaceutical business comprising manufacturing, licensing, or distributing kits containing or relating to the formulations or dosing regimens of random copolymer described herein.

Claims56

Dependent claims

1-142. (canceled)

A method of treating multiple sclerosis comprising the step of administering to a subject in need thereof an effective amount of a random copolymer composition, wherein the random copolymer composition is selected from the group consisting of:

(a) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an input molar ratio of about 1.0:1.0:10.0:6.0 respectively, and has a length of at least 52 amino acids;
(b) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an output molar ratio of about 1.0:1.2:XA:6.0 respectively, and has a length of at least 35 amino acids wherein XA=11.0 to 30.0;
(c) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 at least respectively, and having a length of about 52 amino acid residues;
(d) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, and having a length of about 75 amino acid residues;
and
(e) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) in an output average molar ratio of about 1.0:2.0:6.0:5.0 respectively, has a length of 52 amino acids, and wherein residues 1-10 of the copolymer sequence has a ratio of about 1.0:2.0:5.5:5.0, residues 11-30 have a ratio of about 1.0:2.0:6.0:5.0, and residues 31-52 have a ratio of about 1.0:2.0:6.5:5.0;
and
(f) a random copolymer composition is selected from the group consisting of VYAK;
VWAK;
VEAK;
FEAK;
VAK;
WAK;
YAK;
FAK;
YEK;
ELSA;
DLYV;
and KEASV.

16 more elements

A pharmaceutical composition comprising a random copolymer composition selected from:

(a) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an input molar ratio of about 1.0:1.0:10.0:6.0 respectively, synthesized by solid phase chemistry, and has a length of at least 52 amino acids;
(b) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an output molar ratio of about 1.0:1.2:
XA:6.0 respectively, synthesized by solid phase chemistry, and has a length of at least 35 amino acids wherein XA=11.0 to 30.0;
(c) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, synthesized by solid phase chemistry and having a length of at least 52 amino acid residues;
(d) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, synthesized by solid phase chemistry and having a length of about 75 amino acid residues;
and
(e) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) in an output average molar ratio of about 1.0:2.0:6.0:5.0 respectively, synthesized by solid phase chemistry, has a length of 52 amino acids, and wherein residues 1-10 of the copolymer sequence has a ratio of about 1.0:2.0:5.5:5.0, residues 11-30 have a ratio of about 1.0:2.0:6.0:5.0, and residues 31-52 have a ratio of about 1.0:2.0:6.5:5.0.
(f) a random copolymer composition is selected from the group consisting of VYAK;
VWAK;
VEAK;
FEAK;
VAK;
WAK;
YAK;
FAK;
YEK;
ELSA;
DLYV;
and KEASV.

16 more elements

A method for ameliorating unwanted immune responses, comprising the step of administering to a subject in need thereof an effective amount of a random copolymer composition, wherein the random copolymer composition is selected from:

(a) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an input molar ratio of about 1.0:1.0:10.0:6.0 respectively, and has a length of 52 amino acids;
(b) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an output molar ratio of about 1.0:1.2:XA:6.0 respectively, and has a length of at least 35 amino acids wherein XA=11.0 to 30.0;
(c) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an output average molar ratio of about 1.0:1.2:18.0:6.0 respectively, wherein the copolymer has a length of 52 amino acids, and wherein residues 1-10 of the copolymer sequence has a ratio of about 1.0:1.2:16:6, residues 11-30 have a ratio of about 1.0:1.2:18:6, and residues 31-52 have a ratio of about 1.0:1.2:20:6;
(d) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, and having a length of about 52 amino acid residues;
(e) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, and having a length of about 75 amino acid residues;
and
(f) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) in an output average molar ratio of about 1.0:2.0:6.0:5.0 respectively, has a length of 52 amino acids, and wherein residues 1-10 of the copolymer sequence has a ratio of about 1.0:2.0:5.5:5.0, residues 11-30 have a ratio of about 1.0:2.0:6.0:5.0, and residues 31-52 have a ratio of about 1.0:2.0:6.5:5.0;
and
(g) a random copolymer composition is selected from the group consisting of VYAK;
VWAK;
VEAK;
FEAK;
VAK;
WAK;
YAK;
FAK;
YEK;
ELSA;
DLYV;
and KEASV.

17 more elements

A method for treating an autoimmune disease, comprising the step of administering to a subject in need thereof an effective amount of a random copolymer composition, wherein the random copolymer composition is selected from:

(a) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an input molar ratio of about 1.0:1.0:10.0:6.0 respectively, and has a length of 52 amino acids;
(b) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an output molar ratio of about 1.0:1.2:XA:6.0 respectively, and has a length of at least 35 amino acids wherein XA=11.0 to 30.0;
(c) a random copolymer composition comprising YFAK (L-tyrosine, L-phenylalanine, L-alanine and L-lysine) in an output average molar ratio of about 1.0:1.2:18.0:6.0 respectively, wherein the copolymer has a length of 52 amino acids, and wherein residues 1-10 of the copolymer sequence has a ratio of about 1.0:1.2:16:6, residues 11-30 have a ratio of about 1.0:1.2:18:6, and residues 31-52 have a ratio of about 1.0:1.2:20:6;
(d) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, and having a length of about 52 amino acid residues;
(e) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) with a molar input ratio of 1.0:2.0:6.0:5.0 respectively, and having a length of about 75 amino acid residues;
and
(f) a random copolymer composition comprising YEAK (L-tyrosine, L-glutamate, L-alanine and L-lysine) in an output average molar ratio of about 1.0:2.0:6.0:5.0 respectively, has a length of 52 amino acids, and wherein residues 1-10 of the copolymer sequence has a ratio of about 1.0:2.0:5.5:5.0, residues 11-30 have a ratio of about 1.0:2.0:6.0:5.0, and residues 31-52 have a ratio of about 1.0:2.0:6.5:5.0;
and
(g) a random copolymer composition is selected from the group consisting of VYAK;
VWAK;
VEAK;
FEAK;
VAK;
WAK;
YAK;
FAK;
YEK;
ELSA;
DLYV;
and KEASV.

17 more elements

Dependencies are inferred from the claim text.

Methods of treating disease with random copolymers

Life of this patent

Methods of treating disease with random copolymers

Life of this patent

Abstract

Claims56