Claims for Patent: 6,537,549

Summary for Patent: 6,537,549

Title:	Cytokine antagonists for the treatment of localized disorders
Abstract:	Cytokine antagonists for use in localized clinical disorders are provided for the treatment and prevention of damage to the optic nerve, other cranial nerves, spinal cord, nerve roots, peripheral nerves or muscles caused by any one of the following: a herniated nucleus pulposus, osteoarthritis, other forms of arthritis, disorders of bone, disease, or trauma. The cytokine antagonists are used to treat these disorders by local administration. These cytokine antagonists include antagonists to tumor necrosis factor.
Inventor(s):	Tobinick; Edward L. (Los Angeles, CA)
Assignee:
Application Number:	09/841,844
Patent Claims:	1. A method of treating neurological conditions in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of a fusion protein identified as etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, and pegylated soluble TNF receptor Type I (PEGs TNF-R1) for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose either intralesionally or perilesionally. 2. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating Alzheimer's Disease. 3. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist is performed through any of the following routes: subcutaneous, intrathecal, intramuscular, intranasal, transepidermal, parenteral, transepithelial, or epidural. 4. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating nerve root injury caused by a herniated nucleus pulposus. 5. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating Bell's Palsy. 6. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating Carpal Tunnel Syndrome. 7. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating acute spinal cord injury. 8. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating spinal cord compression. 9. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating spinal stenosis. 10. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating localized disorders of muscle, including muscle spasm, muscle tear, muscle injury, muscle strain, or muscle sprain. 11. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating glaucoma. 12. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist is performed subcutaneously in said human wherein said dosage level is in the range of 1 mg to 300 mg per dose. 13. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist in the form of etanercept is performed intramuscularly in said human wherein said dosage level is in the range of 1 mg to 100 mg. 14. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist in the form of etanercept is performed subcutaneously in said human wherein said dosage level is in the range of 1 mg to 100 mg. 15. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist in the form of etanercept is performed subcutaneously in said human wherein said dosage level is in the range of 10 mg to 25 mg. 16. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist in the form of D2E7 is performed subcutaneously in said human, wherein said dosage level is in the range of 1 mg to 100 mg. 17. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist in the form of D2E7 is performed subcutaneously in said human, wherein said dosage level is in the range of 10 mg to 40 mg. 18. A method of treating or preventing nerve root injury in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said nerve root of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, and pegylated soluble TNF receptor Type I (PEGs TNF-R1) for reducing the inflammation of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose either intralesionally or perilesionally. 19. A method of treating glaucoma in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of the optic nerve or retina of said human, or for modulating the immune response affecting the optic nerve or retina of said human, comprising the step of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, and pegylated soluble TNF receptor Type I (PEGs TNF-R1) for treating glaucoma by reducing the inflammation of the optic nerve or retina of said human, or for modulating the immune response affecting the optic nerve or retina of said human. 20. A method for inhibiting the action of TNF in accordance with claim 19, wherein the step of administering said TNF antagonist is performed through any of the following routes: subcutaneous, intranasal, transepidermal, parenteral, or transepithelial. 21. A method of treating neurological conditions in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, comprising the step of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of a fusion protein identified as etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, and pegylated soluble TNF receptor Type I (PEGs TNF-R1) for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human. 22. A method for inhibiting the action of TNF in accordance with claim 21, wherein the step of administering said dosage level is for treating Alzheimer's Disease. 23. A method for inhibiting the action of TNF in accordance with claim 21, wherein the step of administering said dosage level is for treating glaucoma. 24. A method for inhibiting the action of TNF in accordance with claim 21, wherein the step of administering said dosage level is for treating Postherpetic Neuralgia. 25. A method of treating or preventing nerve root injury in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said nerve root of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of a soluble TNF receptor Type I for reducing the inflammation of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose perilesionally by subcutaneous administration in the lumbar area (for lumbar or sacral nerve roots) or in the cervical area (for cervical nerve roots). 26. A method of treating or preventing nerve root injury in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said nerve root of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of a pegylated soluble TNF receptor Type I for reducing the inflammation of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose perilesionally by subcutaneous administration in the lumbar area (for lumbar or sacral nerve roots) or in the cervical area (for cervical nerve roots). 27. A method of treating or preventing nerve root injury in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said nerve root of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of a molecule containing at least one soluble TNF receptor for reducing the inflammation of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose perilesionally by subcutaneous administration in the lumbar area (for lumbar or sacral nerve roots) or in the cervical area (for cervical nerve roots). 28. A method of treating or preventing nerve root injury in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said nerve root of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist consisting of a molecule which contains a fragment of any of the molecules selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), soluble TNF receptor Type I, and pegylated soluble TNF receptor Type I (PEGs TNF-R1) for reducing the inflammation of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose either intralesionally or perilesionally. 29. A method of treating or preventing nerve root injury caused by a herniated nucleus pulposus in a human by inhibiting the action of TNF, by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said nerve root of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, CDP571 (a humanized monoclonal anti-TNF-alpha IgG4 antibody), CDP 870 (a humanized monoclonal anti-TNF-alpha antibody fragment), D2E7 (a human anti-TNF mAb), a molecule containing a soluble TNF receptor, a molecule containing multiple soluble TNF receptors, and a molecule which contains a fragment of any of the above molecules for reducing the inflammation of said nerve root of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering said dose either intralesionally or perilesionally. 30. A method of treating a pathologic condition in a human by inhibiting the action of TNF, the pathologic condition being spinal cord compression due to metastatic cancer, by administering a TNF antagonist, defined as any of the following types of molecules directed against said TNF: a monoclonal antibody; a monoclonal antibody fragment; a TNF binding protein; or a fusion protein; comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist; and b) administering said dose either intralesionally or perilesionally. 31. A method of treating a pathologic condition in a human by inhibiting the action of TNF, the pathologic condition being tumor metastatic to bone, by administering a TNF antagonist, defined as any of the following types of molecules directed against said TNF: a monoclonal antibody; a monoclonal antibody fragment; a TNF binding protein; or a fusion protein; comprising the steps of: administering a therapeutically effective dosage level to said human of said TNF antagonist; and b) administering said dose either intralesionally or perilesionally. 32. A method of treating a pathologic condition in a human by inhibiting the action of TNF, the pathologic condition being a neurological disease or disorder which is caused or exacerbated by the action of said TNF, by administering a TNF antagonist, defined as any of the following types of molecules directed against said TNF: a monoclonal antibody; a monoclonal antibody fragment; a TNF binding protein; or a fusion protein; comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist; and b) administering said dose either intralesionally or perilesionally. 33. A method of treating a pathologic condition in a human by inhibiting the action of TNF, the pathologic condition being a malignant tumor, which is caused or exacerbated by the action of said TNF, by administering a TNF antagonist, defined as any of the following types of molecules directed against said TNF: a monoclonal antibody; a monoclonal antibody fragment; a TNF binding protein; or a fusion protein; comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist; and b) administering said dose either intralesionally or perilesionally.

Details for Patent 6,537,549

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2019-02-24
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2019-02-24
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2019-02-24
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2019-02-24