Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1998-09-03
2000-02-01
Criares, Theodore J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
514171, 514177, 514406, A61K 3156, A61K 31415
Patent
active
060203560
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a pharmaceutical composition comprising an 2-((1-benayl-indazol-3-yl)-methoxy)-2-methyl propionic acid (bindarit), an immunosuppressant and a pharmaceutically acceptable excipient.
It is known that the autoimmune diseases form a wide group of pathologies characterized by inflammatory phenomena and destruction of tissues caused by the production, by the immune system, of body's own antibodies. Examples of diseases considered to be autoimmune in nature are: rheumatoid arthritis, glomerulonephritis, Hashimoto's thyroiditis, systemic lupus erythematosus, myasthenia gravis, autoimmune hemolytic anemia, autoimmune thrombocytopenic purpura, autoimmune disorders and type 1 diabetes.
Presently, in the autoimmune diseases therapy there are used steroidal and non-steroidal anti-inflammatory drugs, gold compounds, penicillins and immunosuppressants.
Non-steroidal anti-inflammatory drugs (NSAID) show, together with the anti-inflammatory activity, also an antipyretic and a non-narcotic analgesic effect. They are widly used both in the acute inflammatory therapy and in chronic inflammatory treatment. For this reason they are currently used in the treatment of autoimmune pathologies, wherein the inflammatory process is often very important. Even if other mechanisms of action may not be excluded, their activity is mainly due to the capability of inhibiting the enzymes responsible for prostaglandins (PG) and leucotriens synthesis, in particular cyclooxygenases and lipooxygenases. This mechanism of action is mostly responsible also for side effects on different organs (mainly gastrointestinal and renal) that occur as a consequence of the prolonged use of said drugs.
Further, to the mainly symptomatic effects that are obtained by the anti-inflammatory drugs in the acute phase of autoimmune pathologies, the most important therapeutical effects are obtained by non-steroidal drugs such as, for example, cyclophosphamide.
However, this kind of drug can not be administered for prolonged periods of time because of the onset of different type of side effects having considerable side effects.
In fact, that treatment must be stopped because of the onset of toxicity on organs or of systemic nature in more than 20% of patients within 12 months. The remission phases last for a very variable period of time (from 1 to 18 months on average) and, although a second and often a third therapy cycle may give positive results, more than 50% of patients that initially responded to the therapy must stop it after 3-6 years because of relapses and/or because of the late toxicity. The organs that are most frequently involved are kidneys, liver, blood and reproductive apparatus.
Therefore, toxic effects of therapies employed in autoimmune phatologies are a serious obstacle to their use and thus there is a serious need of a product capable of reducing the undesired side effects of drugs employed in said therapies, thus reducing the doses or the number of administrations.
Now, it has been unexpectatebly found that bindarit (1) allows reducing the immunosuppressants dose in the prolonged treatment of autoimmune diseases, without reducing the therapeutical efficacy thus improving the tolerability.
Therefore, it is a first object of the present invention to provide a pharmaceutical composition comprising bindarit an immunosuppressant and a pharmaceutically acceptable excipient.
Further, it is a second object of the present invention to provide a method of treating autoimmune diseases characterized by the concurrent administration bindarit and an immunosuppressant.
Typical examples of immunosuppressants according to the present invention are: cyclosporin, azatioprin, methotrexate, cyclophsphamide, FK 506, cortisol, betametasone, cortisone, desametasone, flunisolide, prednisolone, methylprednisolone, prednisone, triamcinolone, alclometasone, amcinonide desonide and desoxymetasone.
Typical examples of diseases that can benefit from the concurrent treatment with bindarit and an immunosuppressant are: rehumatoid arthritis, glomeru
Dionisio Paolo
Guglielmotti Angelo
Angelini Ricerche S.p.A. Societa Consortile
Criares Theodore J.
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