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Use of Combinations Comprising a Corticosteroid and a Pyrimidopyrimidine in the Treatment of Inflammatory Diseases

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Use of Combinations Comprising a Corticosteroid and a Pyrimidopyrimidine in the Treatment of Inflammatory Diseases (19) & (11) EP 2 070 550 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 17.06.2009 Bulletin 2009/25 A61K 45/06 (2006.01) A61K 31/519 (2006.01) A61P 37/00 (2006.01) (21) Application number: 09002049.6 (22) Date of filing: 13.10.2004 (84) Designated Contracting States: • Borisy, Alexis AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Arlington, MA 02476 (US) HU IE IT LI LU MC NL PL PT RO SE SI SK TR • Zimmermann, Grant R. Designated Extension States: Somerville, MA 02144 (US) AL HR LT LV MK •Jost-Price, Edward Roydon West Roxbury, MA, 02132 (US) (30) Priority: 15.10.2003 US 512415 P • Manivasakam, Palaniyandi West Roxbury, MA 02132 (US) (62) Document number(s) of the earlier application(s) in accordance with Art. 76 EPC: (74) Representative: Bösl, Raphael Konrad 04809944.4 / 1 680 121 Isenbruck Bösl Hörschler Wichmann Huhn LLP Patentanwälte (71) Applicant: Combinatorx, Incorporated Prinzregentenstrasse 68 Cambridge, MA 02142 (US) 81675 München (DE) (72) Inventors: Remarks: • Keith, Curtis This application was filed on 13-02-2009 as a Boston, MA 02118 (US) divisional application to the application mentioned under INID code 62. (54) Use of combinations comprising a corticosteroid and a pyrimidopyrimidine in the treatment of inflammatory diseases (57) The invention features a method for treating a The invention also features a composition containing a patient diagnosed with, or at risk of developing, an im- tetra-substituted pyrimidopyrimidine in combination with munoinflammatory disorder by administering to the pa- one or more additional agents. tient a tetra-substituted pyrimidopyrimidine, either alone or in combination with one or more additional agents. EP 2 070 550 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 070 550 A1 Description Background of the Invention 5 [0001] The invention relates to the treatment of immunoinflammatory disorders. Immunoinflammatory conditions are characterized by the inappropriate activation of the body’s immune defenses. Rather than targeting infectious invaders, the immune response targets and damages the body’s own tissues or transplanted tissues. The tissue targeted by the immune system varies with the disorder. For example, in multiple sclerosis, the immune response is directed against the neuronal tissue, while in Crolm’s disease the digestive tract is targeted. Immunoinflammatory disorders affect millions 10 of individuals and include conditions such as asthma, allergic intraocular inflammatory diseases, arthritis, atopic derma- titis, atopic eczema, diabetes, hemolytic anaemia, inflammatory dermatoses, inflammatory bowel or gastrointestinal disorders (e.g., Crohn’s disease and ulcerative colitis), multiple sclerosis, myasthenia gravis, pruritis/inflammation, pso- riasis, rheumatoid arthritis, cirrhosis, and systemic lupus erythematosus. [0002] Current treatment regimens for immunoinflammatory disorders, transplanted organ rejection, and graft versus 15 host disease typically rely on immunosuppressive agents. The effectiveness of these agents can vary and their use is often accompanied by adverse side effects. Thus, improved therapeutic agents and methods for the treatment of im- munoinflammatory conditions are needed. Summary of the Invention 20 [0003] The invention features a method for treating an immunoinflammatory disease by administering to a patient in need thereof certain tetra-substituted pyrimidopyrimidines, either alone or in combination with any of a number of com- panion compounds, including an antihistamine, a corticosteroid, rolipram, ibudilast, a tricyclic or tetracyclic antidepres- sant, an SSRI, a non-steroidal anti-inflammatory drug, a non-steroidal immunophilin-dependent immunosuppressant, 25 and an analog of any thereof, as described herein. [0004] Accordingly, in one aspect, the invention features a method of treating a patient having an immunoinflammatory disease by administering to the patient a tetra-substituted pyrimidopyrimidine in an amount and for duration to treat the patient [0005] In a related aspect, the invention features a method for treating a patient having an immunoinflammatory 30 disorder by administering to the patient tetra-substituted pyrimidopyrimidine and an antihistamine simultaneously or within 14 days of each other in amounts sufficient to treat the patient. [0006] In another aspect, the invention features a method of decreasing proinflammatory cytokine secretion or pro- duction in a patient by administering to the patient a tetra-substituted pyrimidopyrimidine and an antihistamine simulta- neously or within 14 days of each other in amounts sufficient to decrease proinflammatory cytokine secretion or production 35 in the patient [0007] In another aspect, the invention features a composition that includes a tetra-substituted pyrimidopyrimidine and an antihistamine. A particularly desirable tetra-substituted pyrimidopyrimidine is dipyridamole. The composition may be formulated for topical or systemic administration. [0008] In another aspect, the invention features a kit that includes: (i) a composition that includes a tetra-substituted 40 pyrimidopyrimidine and an antihistamine; and (ii) instructions for administering the composition to a patient diagnosed with or at risk of developing an immunoinflammatory disorder. [0009] In a related aspect, the invention features a kit that includes: (i) an antihistamine; (ii) a tetra-substituted pyrim- idopyrimidine; and (iii) instructions for administering the tetra-substituted pyrimidopyrimidine and the antihistamine to a patient diagnosed with or at risk of developing an immunoinflammatory disorder. 45 [0010] In another aspect, the invention features a composition that includes a tetra-substituted pyrimidopyrimidine and a corticosteroid. Particularly desirable corticosteroids are prednisolone, cortisone, dexamethasone, hydrocortisone, methylprednisolone, fluticasone, prednisone, triamcinolone, and diflorasone. The composition may be formulated for topical or systemic administration (e.g., oral administration). One or both of the drugs may be present in the composition in a low dosage or a high dosage, each of which is defined herein. 50 [0011] In another aspect, the invention features a method of decreasing proinflammatory cytokine secretion or pro- duction in a patient by administering to the patient a tetra-substituted pyrimidopyrimidine and a corticosteroid simulta- neously or within 14 days of each other in amounts sufficient to decrease proinflammatory cytokine secretion or production in the patient [0012] In a related aspect, the invention features a method for treating a patient diagnosed with or at risk of developing 55 an immunoinflammatory disorder by administering to the patient a tetra-substituted pyrimidopyrimidine and a corticos- teroid simultaneously or within 14 days of each other in amounts sufficient to treat the patient. [0013] In another aspect, the invention features a kit that includes: (i) a composition that includes a tetra-substituted pyrimidopyrimidine and a corticosteroid; and (ii) instructions for administering the composition to a patient diagnosed 2 EP 2 070 550 A1 with or at risk of developing an immunoinflammatory disorder. [0014] In a related aspect, the invention features a kit that includes: (i) a tetra-substituted pyrimidopyrimidine; (ii) a corticosteroid; and (iii) instructions for administering the tetra-substituted pyrimidopyrimidine and the corticosteroid to a patient diagnosed with or at risk of developing an immunoinflammatory disorder. 5 [0015] In another aspect, the invention features a composition that includes tetra-substituted pyrimidopyrimidine and ibudilast. The composition may be formulated for topical or systemic administration. [0016] In another aspect, the invention features a method of decreasing proinflammatory cytokine secretion or pro- duction in a patient by administering to the patient tetra-substituted pyrimidopyrimidine and ibudilast simultaneously or within 14 days of each other in amounts sufficient to decrease proinflammatory cytokine secretion or production in the 10 patient. [0017] In a related aspect, the invention features a method for treating a patient diagnosed with or at risk of developing an immunoinflammatory disorder by administering to the patient tetra-substituted pyrimidopyrimidine and ibudilast si- multaneously or within 14 days of each other in amounts sufficient to treat the patient In another aspect, the invention features a kit that includes: (i) a composition that includes tetra-substituted pyrimidopyrimidine and ibudilast; and (ii) 15 instructions for administering the composition to a patient diagnosed with or at risk of developing an immunoinflammatory disorder. [0018] In a related aspect, the invention features a kit that includes: (i) tetra-substituted pyrimidopyrimidine; (ii) ibudilast; and (iii) instructions for administering the tetra-substituted pyrimidopyrimidine and the ibudilast to a patient diagnosed with or at risk of developing an immunoinflammatory disorder. 20 [0019] In another aspect, the invention features a composition that includes tetra-substituted pyrimidopyrimidine and rolipram. The composition may be formulated for topical or systemic administration. [0020] In another aspect, the invention features a method of decreasing proinflammatory cytokine secretion or pro- duction in a patient by administering to the patient a tetra-substituted pyrimidopyrimidine and rolipram simultaneously or within 14 days of each other in amounts sufficient to decrease proinflammatory cytokine
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