METHODS FOR PREVENTING, POSTPONING OR IMPROVING THE OUTCOME OF SPINAL DEVICE AND FUSION PROCEDURES

• US 20100093829A1
• Filed: 07/09/2007
• Published: 04/15/2010
• Est. Priority Date: 07/07/2006
• Status: Abandoned Application

• Current Assignee: Bioassets Development Corporation (Teva Pharmaceutical Industries Limited)
• Original Assignee: Bioassets Development Corporation (Teva Pharmaceutical Industries Limited)
• Inventors: Gorman, James R.
• Application Number:
  US12/307,902
• Publication Number:
  US 20100093829A1
• Time in Patent Office: Days
• US Class Current: 514/44.00A
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/435 having six-membered rings with one nitrogen as the only ring hetero atom
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Methods for identifying subjects who could benefit therapeutically from administration of a high specificity cytokine inhibitor are provided. Subjects that are identified include those that are eligible, based on pre-determined criteria, for a spinal device or fusion procedure, such as the implantation of a nucleus replacement device, an annular repair device, or a fusion device. Methods of preventing such procedures or improving the outcome of such procedures are also provided, and include administering a TAT to the subject by any route or regimen of administration, including the regimens described herein.

Claims

1-11. -11. (canceled)

12. A method for preventing or postponing a spinal device or fusion procedure in a subject wherein the subject meets at least one predetermined standard of eligibility (SOE) for a spinal device or fusion procedure, the method comprising:

a) identifying the subject as a subject eligible for the spinal device or fusion procedure;

b) administering to the subject a therapeutically effective amount of at least one direct TNF-I; and

c) determining whether the subject'"'"'s eligibility for the spinal device or fusion procedure has been prevented or postponed.

14. The method of claim 12, wherein the subject is:

a) eligible for a disk nucleus replacement procedure;

b) eligible for an annular repair procedure;

c) eligible for a dynamic stabilization procedure;

d) eligible for an artificial disk procedure;

e) eligible for an interbody spine fusion;

f) eligible for a posterolateral fusion;

g) eligible for an interbody spine fusion using BMP-2;

h) eligible for kyphoplasty, vertebroplasty or vertebral restoration;

i) eligible for facet replacement;

or

j) eligible for a spinal procedure augmented by an anti-adhesive.

31. The method of claim 12, wherein the administration in b) treats the subject so that the subject does not undergo a spinal device or fusion procedure in at least the first three months after the initial administration of the TNF-I.

33. The method of claim 12, wherein the direct TNF-I is selected from the group consisting of an antibody or antibody fragment, a fusion protein, a peptide, a SMIP, a small molecule, an oligonucleotide, an oligosaccharide, a soluble cytokine receptor or fragment thereof, a soluble TNF receptor Type I or a functional fragment thereof, a polypeptide that binds to TNF, and a dominant negative TNF molecule.

34. The method of claim 33, wherein the oligonucleotide is an siRNA.

35. The method of claim 33, wherein the direct TNF-I is selected from the group consisting of:

Humira®

(adalimumab/D2E7);

Remicade®

(infliximab);

Cimzia®

(CDP-870);

Humicade®

(CDP-570);

golimumab (CNTO

     148);

CytoFab (Protherics);

AME-527;

anti-TNF-Receptor 1 mAb or dAb;

ABX-10131;

polyclonal anti-TNF antibodies;

anti-TNF polyclonal anti-serum;

anti-TNF or anti-TNF-R SMIPs (Trubion);

Enbrel®

(etanercept);

pegsunercept/PEGs TNF-R1, onercept;

recombinant TNF binding protein (r-TBP-1);

trimerized TNF antagonist;

SSR-150106 (Sanofi-Synthelabo);

ABX-0402 (Ablynx);

nanobody therapeutics (Ablynx);

trimerized TNF antagonist (Borean);

humanized anti-TNF mAb (Biovation);

Dom-0200 (Domantis);

Genz-29155 (Genzyme);

agarooligosaccharide (Takara Shuzo);

HTDN-TNF (Xencor); and

therapeutic human polyclonal anti-TNF and anti-TNF-R antibodies (THP).

37. The method of claim 12, wherein the administration comprises:

(a) an induction regimen comprising a direct TNF-I; and

(b) a maintenance regimen comprising a direct TNF-I.

39. The method of claim 37, wherein the induction regimen is administered intrathecally, intradiskally, peridiskally, or epidurally, or combinations thereof.

40. The method of claim 37, wherein the maintenance regimen comprises systemic or parenteral administration.

47. The method of claim 37, wherein the induction regimen is administered locally to a site of the spine pathology of the subject, and wherein the maintenance regimen is administered systemically or parenterally.

53. The method of claim 12, wherein the direct TNF-I is administered locally to a site of spine pathology of the subject.

13. (canceled)

15-30. -30. (canceled)

32. (canceled)

36. (canceled)

38. (canceled)

41-46. -46. (canceled)

48-52. -52. (canceled)

54-58. -58. (canceled)

59. A method for improving the outcome of a spinal device or fusion procedure in a subject, wherein the subject meets at least one predetermined SOE for a spinal device or fusion procedure, the method comprising:

a) identifying the subject as a subject eligible for the spinal device or fusion procedure;

b) administering to the subject a therapeutically effective amount of at least one direct TNF-I; and

c) performing the spinal device or fusion procedure, wherein the spinal device or fusion procedure is selected from a spinal device or fusion procedure that implants one or more of an annular repair or replacement device, a dynamic stabilization device, a kyphoplasty/vertebroplasty/vertebral restoration device, a facet replacement and fixation device, a dural repair device, or a spine fusion device.

61. The method of claim 59, wherein the subject is:

a) eligible for an annular repair procedure;

b) eligible for a dynamic stabilization procedure;

c) eligible for an interbody spine fusion;

d) eligible for an interbody spine fusion using BMP-2;

d) eligible for a posterolateral fusion;

e) eligible for kyphoplasty, vertebroplasty or vertebral restoration;

or

f) eligible for facet replacement.

71. The method of claim 59, wherein the direct TNF-I is selected from the group consisting of an antibody or antibody fragment, a fusion protein, a peptide, a small modular immuno pharmaceutical (SMIP), a small molecule, an oligonucleotide, an oligosaccharide, a soluble cytokine receptor or fragment thereof, a soluble TNF receptor Type I or a functional fragment thereof, a polypeptide that binds to TNF, and a dominant negative TNF molecule.

72. The method of claim 71, wherein the oligonucleotide is an siRNA.

73. The method of claim 71, wherein the direct TNF-I is selected from the group consisting of:

Humira®

(adalimumab/D2E7);

Remicade®

(infliximab);

Cimzia®

(CDP-870);

Humicade®

(CDP-570);

golimumab (CNTO

     148);

CytoFab (Protherics);

AME-527;

anti-TNF-Receptor 1 mAb or dAb;

ABX-10131;

polyclonal anti-TNF antibodies;

anti-TNF polyclonal anti-serum;

anti-TNF or anti-TNF-R SMIPs (Trubion);

Enbrel®

(etanercept);

pegsunercept/PEGs TNF-R1, onercept;

recombinant TNF binding protein (r-TBP-1);

trimerized TNF antagonist;

SSR-150106 (Sanofi-Synthelabo);

ABX-0402 (Ablynx);

nanobody therapeutics (Ablynx);

trimerized TNF antagonist (Borean);

humanized anti-TNF mAb (Biovation);

Dom-0200 (Domantis);

Genz-29155 (Genzyme);

agarooligosaccharide (Takara Shuzo);

HTDN-TNF (Xencor); and

therapeutic human polyclonal anti-TNF and anti-TNF-R antibodies (THP).

75. The method of claim 59, wherein the administration comprises:

(a) an induction regimen comprising a direct TNF-I; and

(b) a maintenance regimen comprising a direct TNF-I.

77. The method of claim 75, wherein the induction regimen is administered intrathecally, intradiskally, peridiskally, or epidurally, or combinations thereof.

78. The method of claim 75, wherein the maintenance regimen comprises systemic or parenteral administration.

60. (canceled)

62-70. -70. (canceled)

74. (canceled)

76. (canceled)

79-86. -86. (canceled)

87. A method for improving the outcome of a spinal device or fusion procedure in a subject, wherein the subject meets at least one predetermined SOE for a spinal device or fusion procedure, and wherein the spinal device or fusion procedure implants a device that is a source of a targeted anti-inflammatory therapy (TAT), the method comprising:

a) identifying the subject as a subject eligible for the spinal device or fusion procedure;

b) administering to the subject a therapeutically effective amount of at least one direct TNF-I that is in addition to the TAT derived from the implanted device; and

c) performing the spinal device or fusion procedure.

91. The method of claim 87, wherein the direct TNF-I is selected from the group consisting of an antibody or antibody fragment, a fusion protein, a peptide, a SMIP, a small molecule, an oligonucleotide, an oligosaccharide, a soluble cytokine receptor or fragment thereof, a soluble TNF receptor Type I or a functional fragment thereof, a polypeptide that binds to TNF, and a dominant negative TNF molecule.

92. The method of claim 91, wherein the oligonucleotide is an siRNA.

93. The method of claim 91, wherein the direct TNF-I is selected from the group consisting of:

Humira®

(adalimumab/D2E7);

Remicade®

(infliximab);

Cimzia®

(CDP-870);

Humicade®

(CDP-570);

golimumab (CNTO

     148);

CytoFab (Protherics);

AME-527;

anti-TNF-Receptor 1 mAb or dAb;

ABX-10131;

polyclonal anti-TNF antibodies;

anti-TNF polyclonal anti-serum;

anti-TNF or anti-TNF-R SMIPs (Trubion);

Enbrel®

(etanercept);

pegsunercept/PEGs TNF-R1, onercept;

recombinant TNF binding protein (r-TBP-1);

trimerized TNF antagonist;

SSR-150106 (Sanofi-Synthelabo);

ABX-0402 (Ablynx);

nanobody therapeutics (Ablynx);

trimerized TNF antagonist (Borean);

humanized anti-TNF mAb (Biovation);

Dom-0200 (Domantis);

Genz-29155 (Genzyme);

agarooligosaccharide (Takara Shuzo);

HTDN-TNF (Xencor); and

therapeutic human polyclonal anti-TNF and anti-TNF-R antibodies (THP).

95. The method of claim 87, wherein the administration comprises:

(a) an induction regimen comprising a direct TNF-I; and

(b) a maintenance regimen comprising a direct TNF-I.

88-90. -90. (canceled)

94. (canceled)

96-105. -105. (canceled)