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  Methods, compositions, and kits for the treatment of medical conditionsUSPTO Application #: 20070225217Title: Methods, compositions, and kits for the treatment of medical conditions Abstract: The invention features methods, compositions, and kits for treating an immunoinflammatory disorder, an ophthalmic disorder, a musculoskeletal disorder or pain associated therewith, a periodontal disease, or a disease or condition associated with an increased serum CRP level. (end of abstract) Agent: Clark & Elbing LLP - Boston, MA, US Inventors: Todd W. Chappell, Benjamin A. Auspitz, Edward Roydon Jost-Price USPTO Applicaton #: 20070225217 - Class: 514011000 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) Doai, Cyclopeptides, Monocyclic The Patent Description & Claims data below is from USPTO Patent Application 20070225217. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit of U.S. Provisional Application No. 60/735,989, filed Nov. 9, 2005, which is hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] The invention relates to the treatment of immunoinflammatory disorders and ophthalmic disorders. [0003] Immunoinflammatory disorders 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 Crohn's disease the digestive tract is targeted. Immunoinflammatory disorders affect millions of individuals and include conditions such as asthma, allergic intraocular inflammatory diseases, arthritis, atopic dermatitis, 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, psoriasis, rheumatoid arthritis, cirrhosis, and systemic lupus erythematosus. [0004] Current treatment regimens for immunoinflammatory disorders 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 immunoinflammatory disorders are needed. [0005] Musculoskeletal disorders such as arthritis are among the most frequent causes of physical disability among older adults. The three most common types of arthritis are osteoarthritis (OA), rheumatoid arthritis (RA), and gout. Osteoarthritis is the most common joint disease, with radiological evidence of its existence found in 50% of the population. [0006] OA affects the hands, lower back, neck, and weight-bearing joints such as the knees, hips, and foot joints. The yearly incidence of OA of the hand is about 50 new cases per 1,000 for persons under age 40, rising to 65 per 1,000 for ages 40-59 and 110 per 1000 for ages 60 and greater. [0007] OA has been characterized as a slowly evolving degenerative disease with a multifactorial etiology that may differ depending on the joint site. OA occurs when cartilage, the tissue that cushions the ends of the bones within the joints, begins to break down and wear away. In some cases, all of the cartilage may wear away, leaving bones that rub against each other. Arthroscopic studies of early disease have shown synovitis in approximately half of those joints with cartilage damage, suggesting a localized inflammatory reaction in patients with early OA. Furthermore, numerous studies have identified an association between C-reactive protein (CRP) and OA. CRP is an acute phase response protein whose production is stimulated by cytokines, particularly interleukin-6 (IL-6). The relationship between inflammatory processes and elevation in plasma CRP and pro-inflammatory cytokines is well known. CRP has also been related to the inflammatory activity of rheumatoid arthritis. [0008] Symptoms of OA range from stiffness and intermittent mild pain to severe joint pain and impaired biomechanical function. Although there is no cure for most forms of OA, various therapies can help patients manage symptoms and improve their overall quality of life. Symptomatic treatment of OA traditionally involves administration of non-steroidal anti-inflammatory drugs (NSAIDs), local analgesic therapies, intra-articular corticosteroid injection, and surgery. [0009] Treatment of OA with NSAIDs such as indomethacin, ketoprofen, ibuprofen, acetylsalicylic acid (ASA), and flurbiprofen can relieve pain by reducing local inflammation and attenuating levels of proinflammatory agents. However, long-term NSAID use is compromised by significant gastrointestinal (GI) toxicity. A large multi-center, prospective, observational study involving 1,921 patients with rheumatoid arthritis taking NSAIDs reported that 81% of patients who were hospitalized with serious GI complications had no prior GI problems. This makes it difficult for clinicians to identify patients at risk for GI side-effects. In the United States, it has been conservatively estimated that there are 107,000 annual hospitalizations for NSAID-related GI complications and 16,500 annual NSAID-related deaths among patients with RA or OA. This mortality figure is almost as high as the number of deaths due to asthma, cervical cancer and malignant melanoma combined. [0010] Steroids are known powerful anti-inflammatory agents that have been used in treating OA. However, chronic administration of anti-inflammatory doses of steroids is also limited by well-known toxicities. For example, prolonged use of steroids has been associated with osteoporosis, high blood pressure, neurological complications, suboptimal immune response, and ocular disturbances, limiting their utility in therapeutic situations. A therapeutic agent that, for example, retained the potent anti-inflammatory effects of steroids, or the therapeutic effects of another class of drugs, while limiting the associated toxicities, would be of great benefit to patients with OA or other musculoskeletal disorders. [0011] Periodontal disease refers to diseases of tissues that surround and support teeth, including the gingiva, cementum, periodontal ligament, alveolar process bone, and dental supporting bone. The most common forms of periodontal disease are periodontitis and gingivitis. [0012] Periodontal disease involves the inflammation, destruction and degeneration of periodontal tissues that surround and support mammalian teeth. These periodontal tissues include the crevicular epithelium, junctional epithelium, external marginal epithelium, gingiva, alveolar bone, periodontal ligament, and cementum. The loss of supporting bone in periodontitis is the latest stage of this progressive disorder and is the major cause of tooth loss in adults. [0013] Periodontal disease is typically classified as gingivitis and periodontitis according to the progress of disease. "Gingivitis" refers to a condition in which inflammation is localized within the gingiva and no lesion occurs in the bone and periodontal ligament, and a pocket is relative pocket. "Periodontitis" refers to a condition in which the inflammation of gingiva reaches the periodontal ligament and alveolar bone, the pocket becomes a periodontal pocket, and the attachment level (the position of attachment) is on the root apex side downward from the cementum-enamel junction. The inflammation prolongs and proceeds toward deep parts with a deepening periodontal pocket. [0014] The relationship between inflammatory processes and elevation in plasma C-reactive protein (CRP) and proinflammatory cytokines is well known, and this relationship is observed in periodontitis. In atherosclerotic heart disease where elevated plasma CRP levels are a known risk factor, a correlation with the incidence of periodontitis has also been reported. As such, agents that can modify levels of inflammation in periodontitis would be expected to be active across such inflammatory diseases. Indeed, treatment of periodontitis with NSAIDs such as indomethacin, ketoprofen, ibuprofen, ASA and flurbiprofen, can reduce local inflammation and attenuate levels of pro-inflammatory agents. However, there have been no reports on the use of corticosteroids to treat periodontitis, perhaps because chronic administration of antiinflammatory doses of steroids is limited by well known toxicities. An agent that could provide the anti-inflammatory effect of steroids without the associated toxicity is desirable for the treatment of periodontal disease. Such an agent would also be useful for reducing the level of serum CRP and, consequently, for treating diseases and conditions associated with an elevated serum CRP level. SUMMARY OF THE INVENTION [0015] The invention features compositions, methods, and kits for the treatment of immunoinflammatory disorders and ophthalmic disorders. [0016] In one aspect, the invention features a composition that includes a drug pair selected from the pairs listed on Table 1A and Table 3. Desirably, one or both drugs are present in amounts that together are sufficient to treat an immunoinflammatory disorder, ophthalmic disorder, or musculoskeletal disorder, or pain, tenderness, impairment in mobility, soft tissue swelling, or bony swelling associated therewith in a patient in need thereof. Exemplary drug pairs are: antihistamine and phosphodiesterase inhibitor; antihistamine and SSRI; antihistamine and tricyclic compound; antinfective and anticoccidial compound; corticosteroid and antihistamine; corticosteroid and phosphodiesterase inhibitor; corticosteroid and prostaglandin; NsIDI and alpha-2 adrenoceptor agonist; NsIDI and antihistamine; NsIDI and NMDA antagonist/antidyskinetic; NsIDI and prostaglandin; NsIDI and sympathomimetic; prostaglandin and phosphodiesterase inhibitor; prostaglandin and tetra-substituted pyrimidopyrimidine; sympathomimetic and NMDA antagonist/antidyskinetic; sympathomimetic and prostaglandin; sympathomimetic and tetra-substituted pyrimidopyrimidine; sympathomimetic and tricyclic compound; tetra-substituted pyrimidopyrimidine and phosphodiesterase inhibitor; tetra-substituted pyrimidopyrimidine and SSRI; tetra-substituted pyrimidopyrimidine and tricyclic compound; and tricyclic compound and calcium channel blocker. [0017] One or both drugs in said pair may be present in the composition in a low dosage or in a high dosage. In certain embodiments, the composition is formulated for topical or systemic administration. In one embodiment, the composition is formulated for ophthalmic administration. [0018] In another aspect, the invention features a method for treating a patient diagnosed with an immunoinflammatory disorder by administering to the patient a drug pair selected from the pairs listed on Table 1A or Table 3. Desirably, the first and second drug of said drug pair are administered simultaneously or within 14 days of each other and in amounts that together are sufficient to treat the patient. Optionally, the patient may also be administered one or more additional drugs (e.g., an NSAID, corticosteroid, COX-2 inhibitor, biologic, DMARD, small molecule immunomodulator, xanthine, anticholinergic compound, beta receptor agonist, bronchodilator, NsIDI, vitamin D analog, psoralen, retinoid, or 5-amino salicylic acid). [0019] In a related aspect, the invention features a method of modulating an immune response (e.g., by decreasing proinflammatory cytokine secretion or production, or by modulating adhesion, gene expression, chemokine secretion, presentation of MHC complex, presentation of costimulation signals, or cell surface expression of other mediators) in a patient by administering to the patient a drug pair selected from the pairs listed on Table 1A simultaneously or within 14 days of each other in amounts sufficient to modulate the immune response in the patient. [0020] In another aspect, the invention features a method for treating a patient diagnosed with an ophthalmic disorder by administering to the patient a drug pair selected from the pairs listed on Table 1A or Table 3. Desirably, the first and second drug of said drug pair are administered simultaneously or within 14 days of each other in amounts that together are sufficient to treat the patient. Optionally, the patient may also be administered one or more additional drugs (e.g., an anti-VEGF compound, corticosteroid, NSAID, antiallergic agent, antihistamine, glaucoma-treating agent, antibiotic, antiviral agent, or antimycotic agent) or receive photodynamic therapy. [0021] In any of the foregoing methods one or both drugs in said pair are administered in a low dosage or in a high dosage. The drugs may be administered within 10 days of each other, within five days of each other, within twenty-four hours of each other, or simultaneously. Continue reading... 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