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(12) Patent Application Publication (10) Pub. No.: US 2012/0225053 A1 Dushenkov Et Al US 20120225053A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0225053 A1 Dushenkov et al. (43) Pub. Date: Sep. 6, 2012 (54) COMPOSITIONS AND METHODS FOR THE A6IP 9/02 (2006.01) PREVENTION AND TREATMENT OF A6IP 7/06 (2006.01) CONDITIONS ASSOCATED WITH A63L/7008 (2006.01) NFLAMATION A638/48 (2006.01) A6IR 36/287 (2006.01) (76) Inventors: Slavik Dushenkov, Fort Lee, NJ A 6LX 3L/75 (2006.01) (US); Patricia Lucas-Schnarre, A638/39 (2006.01) Metuchen, NJ (US); Julie Beth A6II 35/60 (2006.01) Hirsch, Branchburg, NJ (US); A636/906 (2006.01) David Evans, Belle Mead, NY A6IR 36/16 (2006.01) (US); Kitty Evans, legal A6IR 36/258 (2006.01) representative, Merritt Island, FL A636/87 (2006.01) (US) A636/76 (2006.01) A636/736 (2006.01) (21) Appl. No.: 11/920,973 A636/8 (2006.01) A6IP 29/00 (2006.01) (22) PCT Filed: May 24, 2006 (52) U.S. Cl. ........ 424/94.65: 514/456; 514/62; 424/771; (86). PCT No.: PCT/USO6/2O542 514/54: 514/17.2: 424/523; 424/756; 424/752: 424/728; 424/766; 424/769; 424/735; 424/760 S371 (c)(1), (2), (4) Date: May 2, 2012 (57) ABSTRACT Related U.S. Application Data The present invention provides methods for preventing, treat ing, managing and/or ameliorating a condition associated (60) Provisional application No. 60/684,487, filed on May with inflammation (e.g., an inflammatory disorder) or a 24, 2005. symptom thereof, the methods comprising administering to a subject in need thereof an effective amount of a theaflavin Publication Classification composition and an effective amount of one or more therapies (51) Int. Cl. other than Such a theaflavin composition. In particular, the A6 IK3I/353 (2006.01) present invention provides methods for preventing, treating, A6 IP II/06 (2006.01) managing and/or ameliorating a condition associated with A6IP 25/00 (2006.01) inflammation (e.g., an inflammatory disorder) or a symptom A6IPI/00 (2006.01) thereof, the methods comprising administering to a subject in A6IP II/00 (2006.01) need thereof an effective amount of a theaflavin composition, A6IP37/08 (2006.01) an effective amount of a glucosamine composition, and A6IP3I/00 (2006.01) optionally one or more other therapies. US 2012/0225053 A1 Sep. 6, 2012 COMPOSITIONS AND METHODS FOR THE inflammatory disorders. Many cytotoxic agents frequently PREVENTION AND TREATMENT OF cause stomatitis, erythema, slopecia, nausea, vomiting, diar CONDITIONS ASSOCATED WITH rhea, and damage to major organs such as the kidney and liver. NFLAMATON Further, the long-term usage of immunosuppressive agents usually leaves the patient defenseless to infections. 0007 New treatment and preventative modalities for 0001. This application is entitled to and claims priority inflammatory disorders are constantly being sought. In par benefit under 35 U.S.C. S 119(e) to U.S. Provisional applica ticular, any new modality that reduces the dosage and/or tion Ser. No. 60/684,487 filed May 24, 2005, which is incor frequency of administration of agents currently being used, or porated herein by reference in its entirety. is capable of making a currently used treatment and/or pre vention more effective is constantly being sought. FIELD OF THE INVENTION 0008. Theaflavins 0002 The present invention provides methods for pre 0009 Black tea extracts have been reported to have a Venting, treating, managing and/or ameliorating a condition protective and therapeutic effect for a number of disorders, associated with inflammation (e.g., an inflammatory disor including cancer and inflammatory conditions. The major der) or a symptom thereof, the methods comprising adminis polyphenols characteristic of black tea are: theaflavin (TF-1), tering to a subject in need thereof an effective amount of a theaflavin-3-gallate and theaflavin-3-gallate mixture (TF-2), theaflavin composition and an effective amount of one or and theaflavin-3,3'-digallate (TF-3). These theaflavin more therapies other than Such a theaflavin composition. polyphenols are fermentation products derived from green tea polyphenols and are responsible for the characteristic color, BACKGROUND OF THE INVENTION fragrance and taste of black tea. 0010 Citation of any reference in Section 2 of this appli 0003) Inflammatory Disorders cation is not to be construed as an admission that such refer 0004 Inflammation plays a fundamental role in host ence is prior art to the present application. defenses and the progression of immune-mediated diseases. The inflammatory response is initiated in response to injury (e.g., trauma, ischemia, and foreign particles) and infection SUMMARY OF THE INVENTION (e.g., bacterial or viral infection) by a complex cascade of 0011. In one aspect, the present invention provides meth events, including chemical mediators (e.g., cytokines and ods and compositions relating to combinations of anti-in prostaglandins) and inflammatory cells (e.g., leukocytes). flammatory therapies. For example, the invention provides, in The inflammatory response is characterized by increased one embodiment, methods for preventing, treating, managing blood flow, increased capillary permeability, and the influx of phagocytic cells. These events can result in Swelling, redness, and/or ameliorating a symptom or a condition associated with warmth (altered heat patterns), and pus formation at the site of inflammation, the methods comprising administering to a injury or infection. Subject in need thereof a composition comprising theaflavin 0005. A delicate well-balanced interplay between the (TF), theaflavin-3-gallate (TF-3-G), theaflavin3'-gallate (TF humoral and cellular immune elements in the inflammatory 3'-G) and/or theaflavin-3,3'-digallate (TF:-3,3'-diG), includ response enables the elimination of harmful agents and the ing black tea extracts, and certain anti-inflammatory thera initiation of the repair of damaged tissue. When this deli pies. In another embodiment, the present invention provides cately balanced interplay is disrupted, the inflammatory methods for preventing, treating, managing and/or ameliorat response may result in considerable damage to normal tissue ing a symptom or a condition associated with inflammation, and may be more harmful than the original insult that initiated the methods comprise administering to a Subject in need the reaction. In these cases of uncontrolled inflammatory thereof a composition comprising TF, TF-3-G, TF-3'-G and/ responses, clinical intervention is needed to prevent tissue or TF-3,3-diG, including black tea extracts, and a therapy that damage and organ dysfunction. slows cartilage degradation and/or rebuilds cartilage, such as, 0006 Diseases such as rheumatoid arthritis, osteoarthritis, e.g., glucosamine. The invention encompasses dietary, pro Crohn's disease, asthma, allergies and inflammatory bowel phylactic or therapeutic protocols for preventing, treating, disease, are characterized by chronic inflammation. Current managing and/or ameliorating conditions associated with treatments for inflammatory disorders involve symptomatic inflammation. medications and immunosuppressive agents to control Symp 0012. The present invention provides methods for reliev toms. For example, nonsteroidal anti-inflammatory drugs ing a symptom of inflammation in a Subject, such as but not (NSAIDs) such as aspirin, ibuprofen, fenoprofen, naproxen, limited to redness, Swelling, edema, excess warmth and pain, tolimetin, Sulindac, meclofenamate sodium, piroxicam, flur the methods comprising administering to a subject in need biprofen, diclofenac, oxaprozin, nabumetone, etodolac, and thereof an effective amount of a theaflavin composition and ketoprofen have analgesic and anti-inflammatory effects. an effective amount of one or more therapies other than Such However, NSAIDs are believed not to be capable of altering a theaflavin composition (e.g., a glucosamine composition). progression of the disease. (Tierney et al. (eds), Current In a specific embodiment, the present invention provides Medical Diagnosis & Treatment, 37 ed., Appleton & Lange methods for reducing the redness, Swelling, edema, excess (1998), p793). Moreover, NSAIDs are known to cause gas warmth and/or pain associated with inflammation, by 20% (in trointestinal side effects. Corticosteroids are another class of some embodiments, 25%, 30%, 35%, 40%, 45%, 50%, 55%, drugs that are commonly used to control inflammatory symp 60%. 65%, 70%, 75%, 80%, 85%, 90%. 95% or more) in a toms. Corticosteroids, like NSAIDs, do not alter the natural Subject, the methods comprising administering to a subject in progression of the disease, and thus, clinical manifestations need thereof an effective amount of a theaflavin composition of active disease commonly reappear when the drug is dis and an effective amount of one or more therapies other than continued. Low doses of immunosuppressive agents such as Such a theaflavin composition (e.g., a glucosamine composi cytotoxic agents are also commonly used in the treatment of tion) as determined by methods well-known in the art. US 2012/0225053 A1 Sep. 6, 2012 0013 The present invention also provides methods for with a therapy other than Such a theaflavin composition to a preventing, treating, managing and/or ameliorating of a con Subject with a condition associated with inflammation (e.g., dition associated with inflammation (e.g., an inflammatory an inflammatory disorder) achieves a 1.5 fold, preferably a 2 disorder) or a symptom thereof, the methods comprising fold, 3 fold, 4 fold, 5 fold, 6 fold, 7 fold, 8 fold, 9 fold, 10 fold, administering to a subject in need thereofan effective
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