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Tnf receptor and steroid hormone in a combined therapyRelated 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, 25 Or More Peptide Repeating Units In Known Peptide Chain StructureTnf receptor and steroid hormone in a combined therapy description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060142197, Tnf receptor and steroid hormone in a combined therapy. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The present invention relates to the use of a TNF Receptor together with a steroid hormone to produce a pharmaceutical composition for the treatment of lethal bacterial and viral infections as well as autoimmune and inflammatory diseases. It also relates to said pharmaceutical compositions for the simultaneous, separate or sequential use of its active ingredients for the above specified treatment. [0002] In particular, it relates to the use of TBP-1 together with dehydroepiandrosterone (DHEA) or its metabolites to produce a pharmaceutical composition for the treatment of septic shock. BACKGROUND OF THE INVENTION [0003] Septic shock as a consequence of Gram-negative bacteremia or endotoxemia remains a critical clinical condition in spite of adequate antibiotic therapy. [0004] It is now known that the lethal consequences of septic shock results from an exaggerated host response, mediated by protein factors such as TNF and interleukin 1 (IL-1), rather than from the pathogen directly. [0005] Tumor necrosis factor (TNF) is a cytokine produced mainly by activated macrophages, which elicits a wide range of biological effects. These include an important role in endotoxic shock and in inflammatory, immunoregulatory, proliferative, cytotoxic and anti-viral activities. [0006] The induction of the various cellular responses mediated by TNF is initiated by its interaction with two distinct cell surface receptors of approximately 55 kDa (also called TNF-R1) and 75 kDa (also called TNF-R2). The extracellular soluble portions of these receptors, called respectively TBP-1 (TNF Binding Protein-1) and TBP-2 (TNF Binding Protein-2), have been isolated and cloned (see EP Patents 308 378, 398 327 and U.S. Pat. No. 5,811,261). [0007] Several studies in animal models of TNF-mediated endotoxic shock indicated that both anti-TNF antibodies and soluble TNF-receptor are able to counteract the lethal effects induced (see for example: Bentler, B et al., Science, 229:869 (1985), Lesslauer, W. et al., Eur. J. Immunol., 21:2883 (1991), Evans, T. J. et al, J. Exp. Med., 180:2173 (1994) and Mohler K. M. et al., J. Immunol. 151:1548 (1993)). [0008] The in vivo protective effects of urinary as well as recombinant TBP-1 (derived from both CHO and E. Coli cells) in experimental models of septic shock have already been demonstrated (see Bertini, R. et al., Eur. Cytokine Netw. 4(1):39 (1993) and Ythier A., et al., Cytokines, 5:459 (1993)). [0009] DHEA (INN: Prasterone) is an adrenocortical steroid hormone which is an intermediate in the biosynthesis of other hormones including testosterone and estradiol-17.beta.. [0010] The precise biological functions of DHEA are still unclear. Experimental and epidemiological data suggest an inverse relationship between low levels of DHEA in serum and morbidity from atherosclerotic cardiovascular disease (see Barret-Connor, D. et al., N. Engl. J. Med. 315:1519 (1986)), cancer (see Gordon, G. B., et al., Cancer Res. 51:1366 (1991)) and immunodeficiency virus (HIV) infection (Villette, J. M. et al. J. Clin. Endocrinol. Metab. 70:572 (1990)). [0011] An immunomodulating activity of this drug has also been reported; in particular, DHEA has been shown to prevent the development of systemic lupus erythematosus in a mouse model (Lucas, J. et al. J. Clin. Invest. 75:2091(1985)). [0012] It has been demonstrated that DHEA regulates the systemic resistance against lethal viral infections induced by different viruses: coxsackievirus B4 (as reported in Loria, R. M. et al., Ann. N.Y. Acad. Sci, 293), herpes virus type 2 (see Loria, R M. et al., J. Med. Virol., 26:301 (1988)), West Nile virus (a neurovirulent Sindbis virus) and Semliki Forest virus (as reported in Ben-Nathan, D. et al. Arch. Virol. 20:263 (1989)). [0013] It has also been reported that DHEA has similar protective effects against a lethal bacterial infection induced by Enterococcus faecalis (see Loria, R. M. et al. in Symposium Pharmaco-Clinique, Roussel-Uclaf 9:24 (1989)). [0014] Danenberg, H. D. et al. (Antimicrob. Agents Chemother. 36:2275 (1992)) reported that DHEA has the capability of protecting mice from septic shock induced by lipopolysaccharides (LPS) alone or by Tumor Necrosis Factor alpha (TNF-.alpha.) in combination with D-Galactosamine. LPS administration resulted in high levels of TNF-.alpha., a response that was significantly blocked by DHEA, both in vivo and in vitro. DISCLOSURE OF THE INVENTION [0015] The main object of the present invention is the use of a TNF Receptor in combination with a steroid hormone to produce a pharmaceutical composition for the treatment of lethal bacterial and viral infections as well as autoimmune and inflammatory diseases. The TNF Receptor and the steroid hormone can be administered simultaneously, separately or sequentially. [0016] The Applicants have, in fact, found that in such treatment there is a synergic effect between the two active ingredients. [0017] Another object of the present invention is, therefore, the method for treating lethal bacterial and viral infections as well as autoimmune and inflammatory diseases by administering simultaneously, separately or sequentially an effective amount of TNF Receptor and an effective amount of a steroid hormone, together with a pharmaceutically acceptable excipient. [0018] A further object of the present invention are the pharmaceutical compositions containing a TNF Receptor and a steroid hormone, in the presence of one or more pharmaceutically acceptable excipients, for the simultaneous, separate or sequential administration of its active ingredients in the treatment of lethal bacterial and viral infections as well as autoimmune and inflammatory diseases. [0019] In case of separate or sequential use of the two active ingredients, the pharmaceutical compositions of the invention will consist of two different formulations, each comprising one of the two active ingredients together with one or more pharmaceutically acceptable excipients. [0020] The administration of such active ingredients may be by intravenous, intramuscular or subcutaneous route. Other routes of administration, which may establish the desired blood levels of the respective ingredients, are comprised by the present invention. [0021] Non-limitative examples of pathologies, in which the above active ingredients are indicated, are the following: septic shock, AIDS, rheumatoid arthritis, lupus erythematosus and multiple sclerosis. Particularly preferred is the treatment of septic shock. Continue reading about Tnf receptor and steroid hormone in a combined therapy... Full patent description for Tnf receptor and steroid hormone in a combined therapy Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Tnf receptor and steroid hormone in a combined therapy patent application. Patent Applications in related categories: 20090281023 - Mixtures of calcitonin drug-oligomer conjugates and methods of use in pain treatment - A mixture of conjugates in which each conjugate in the mixture comprises a calcitonin drug coupled to an oligomer that includes a polyalkylene glycol moiety is disclosed. The mixture may lower serum calcium levels in a subject by 10, 15 or even 20 percent or more. Moreover, the mixture may ... 20090281023 - Mixtures of calcitonin drug-oligomer conjugates and methods of use in pain treatment - A mixture of conjugates in which each conjugate in the mixture comprises a calcitonin drug coupled to an oligomer that includes a polyalkylene glycol moiety is disclosed. The mixture may lower serum calcium levels in a subject by 10, 15 or even 20 percent or more. Moreover, the mixture may ... ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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