US2006100167A1PendingUtilityA1

Methods and compositions for the treatment of autoimmune disorders using clofarabine

41
Individually held — no corporate assignee on recordPriority: Sep 27, 2002Filed: Sep 25, 2003Published: May 11, 2006
Est. expirySep 27, 2022(expired)· nominal 20-yr term from priority
Inventors:Christopher Barry WoodStuart Smith
A61P 37/06A61K 45/06A61K 31/724A61P 17/00A61K 31/7076A61K 31/34A61K 31/70Y02A50/30
41
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Claims

Abstract

This invention relates to methods of treating or preventing an autoimmune disorder comprising the administration of clofarabine or a pharmaceutically acceptable salt, hydrate, solvate, clathrate, prodrug or metabolite thereof to a patient in need of such treatment. The invention further relates to methods of treating or preventing an autoimmune disorder comprising the administration of clofarabine or a pharmaceutically acceptable salt, hydrate, solvate, clathrate, prodrug or metabolite thereof and an additional therapeutic agent to a patient in need of such treatment.

Claims

exact text as granted — not AI-modified
1 . A method of treating, managing or preventing an autoimmune disorder which comprises administering to a patient in need of such treatment a therapeutically or prophylactively effective amount of clofarabine or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, clathrate, prodrug or metabolite thereof.  
   
   
       2 . The method of  claim 1  wherein the autoimmune disorder is a disorder of the nervous system, the blood, the gastrointestinal system, the endocrine glands, the skin, the musculoskeletal system, the connective tissue or combinations thereof.  
   
   
       3 . The method of  claim 1  wherein the autoimmune disorder is Alopecia Areata, Ankylosing Spondylitis, Antiphospholipid Syndrome, Autoimmune Addison's Disease, Autoimmune Hemolytic Anemia, Autoimmune Hepatitis, Autoimmune Uveitis, Autoimmune Oophoritis, Autoimmune Orchitis, Behcet's Disease, Bullous Pemphigoid, Cardiomyopathy, Celiac Sprue Dermatitis, Chronic Fatigue Immune Dysfunction Syndrome (CFIDS), Chronic Inflammatory Demyelinating Polyneuropathy, Churg Strauss Syndrome, Cicatricial Pemphigoid, CREST Syndrome, Cold Agglutinin Disease, Crohn's Disease, Dermatitis Herpetiformis, Essential Mixed Cryoglobulinemia, Fibromyalgia Fibromyositis, Graves' Disease, Guillain Barré, Hashimoto's Thyroiditis, Idiopathic Pulmonary Fibrosis, Idiopathic Thrombocytopenia Purpura (ITP), IgA Nephropathy, Insulin dependent Diabetes, Immune Mediated Diabetes, Juvenile Arthritis, Lichen Planus, Ménière's Disease, Mixed Connective Tissue Disease, Myasthenia Gravis, Pemphigus Vulgaris, Pernicious Anemia, Polyarteritis Nodosa, Polychondritis, Polyglandular Syndromes, Polymyalgia Rheumatica, Polymyositis and Dermatomyositis, Primary Agammag lobulinemia, Primary Biliary Cirrhosis, Psoriasis, Raynaud's Phenomenon, Reiter's Syndrome, Rheumatic Fever, Sarcoidosis, Scleroderma, Sjögren's Syndrome, Stiff Man Syndrome, Takayasu Arteritis, Temporal Arteritis, Giant Cell Arteritis, Ulcerative Colitis, Uveitis, Vasculitis, Vitiligo or Wegener's Granulomatosis.  
   
   
       4 . The method of  claim 1  wherein the patient is a mammal.  
   
   
       5 . The method of  claim 4  wherein the mammal is a human.  
   
   
       6 . The method of  claim 5  wherein the human is an adult.  
   
   
       7 . The method of  claim 5  wherein the human is an adolescent.  
   
   
       8 . The method of  claim 5  wherein the human is a child.  
   
   
       9 . The method of  claim 5  wherein the human is an infant.  
   
   
       10 . The method of  claim 1  further comprising the administration of an additional therapeutic agent.  
   
   
       11 . The method of  claim 10  wherein the additional therapeutic agent is an antibiotic, an antiemetic agent, an antidepressant, and antifungal agent, an antiinflammatory agent, an antiviral agent, an immunomodulatory agent, a β-interferon, an alkylating agent, a hormone or a cytokine.  
   
   
       12 . The method of  claim 1  wherein the therapeutically or prophylactively effective amount is greater than 1 mg/kg/day.  
   
   
       13 . The method of  claim 1  wherein the therapeutically or prophylactively effective amount of clofarabine is from about 5 mg/kg/day to about 75 mg/kg/day.  
   
   
       14 . The method of  claim 13  wherein the therapeutically or prophylactively effective amount of clofarabine is from about 20 mg/kg/day to about 60 mg/kg/day.  
   
   
       15 . The method of  claim 14  wherein the therapeutically or prophylactively effective amount of clofarabine is from about 40 mg/kg/day to about 50 mg/kg/day.  
   
   
       16 . The method of  claim 1  wherein the therapeutically or prophylactively effective amount of clofarabine is administered parenterally.  
   
   
       17 . The method of  claim 1  wherein the therapeutically or prophylactively effective amount of clofarabine is administered orally.  
   
   
       18 . A dosage form which comprises clofarabine or a pharmaceutically acceptable prodrug, salt, stereoisomer, solvate, hydrate, clathrate, prodrug or metabolite thereof.  
   
   
       19 . The dosage form of  claim 18  wherein said dosage form is suitable for parenteral, transdermal, mucosal or oral administration to a patient.  
   
   
       20 . The dosage form of  claim 19  wherein said mucosal administration is nasal administration.  
   
   
       21 . The dosage form of  claim 19  wherein said mucosal administration is buccal administration.  
   
   
       22 . The dosage form of  claim 19  wherein said mucosal administration is sublingual administration.  
   
   
       23 . The dosage form of  claim 19  wherein said mucosal administration is rectal administration.  
   
   
       24 . The dosage form of  claim 19  wherein said dosage form is a capsule or a tablet.  
   
   
       25 . The dosage form of  claim 19  wherein said dosage form is an aerosol.  
   
   
       26 . The dosage form of  claim 19  wherein said dosage form is a reconstitutable powder.  
   
   
       27 . The dosage form of  claim 18  wherein the amount of clofarabine is from about 5 mg to about 1000 mg.  
   
   
       28 . The dosage form of  claim 27  wherein the amount of clofarabine is from about 100 mg to about 500 mg.  
   
   
       29 . The dosage form of  claim 28  wherein the amount of clofarabine is from about 200 mg to about 350 mg.  
   
   
       30 . The dosage form of  claim 18  wherein the dosage form is sterile.  
   
   
       31 . A high dose pharmaceutical composition for the treatment of an autoimmune disorder which comprises about 5 to about 1000 mg of clofarabine, or a pharmaceutically acceptable salt, hydrate, clathrate, solvate, prodrug, metabolite or stereoisomer thereof and a pharmaceutically acceptable carrier.  
   
   
       32 . A method of treating multiple sclerosis which comprises administering to a patient in need of such treatment from about 1.25 mg/kg/day to about 80 mg/kg/day of clofarabine or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, clathrate, prodrug or metabolite thereof.  
   
   
       33 . The method of  claim 32  which comprises administering from about 50 mg/kg/day to about 75 mg/kg/day of clofarabine or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, clathrate, prodrug or metabolite thereof.  
   
   
       34 . The method of  claim 33  which comprises administering from about 20 mg/kg/day to about 60 mg/kg/day of clofarabine or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, clathrate, prodrug or metabolite thereof.  
   
   
       35 . The method of  claim 33  which comprises administering from about 40 mg/kg/day to about 50 mg/kg/day of clofarabine or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, clathrate, prodrug or metabolite thereof.  
   
   
       36 . The method of  claim 32  wherein the therapeutically or prophylactively effective amount of clofarabine is administered parenterally.  
   
   
       37 . The method of  claim 32  wherein the therapeutically or prophylactively effective amount of clofarabine is administered orally.

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