The present invention relates to new polyhydroxylated compounds and, in particular, to its activity as fatty acid synthase (FASN) inhibitors and to their use for the treatment of pathological states for which an inhibitor of this enzyme is indicated. The invention further relate to pharmaceutical compositions containing them and to a process for the preparation of such compounds.
CLAIMS 1. A compound of formula (I), an stereoisomer thereof, a pharmaceutically acceptable salt thereof or a pharmaceutically acceptable solvate thereof: <img class="EMIRef" id="491842-imgf000050-0001" /> wherein: R-I, R2, R3, R<4>, R5, Re, R7 and R<8> are independently selected from the group consisting of H, (Ci-C<4>)-alkyl, (Ci-C<4>)-alkoxy, halogen, nitro, NH<2>, (C<r>C<4>)alkyl ester, CONH<2>, (Ci-C<4>)alkylamide, CF<3>, and hydroxyl; Y and Z are each independently selected from C and N; X is a biradical derived from one of the known ring systems containing 2-3 rings of 5-6 members each ring, being the rings aromatic or partially unsaturated, isolated or fused; each ring optionally substituted with one or more groups selected from the group consisting of (Ci-C<4>)-alkyl, (CrC<4>)- alkoxy, halogen, nitro, NH<2>, (CrC<4>)alkyl ester, CONH<2> and (Ci-C<4>)alkylamide; being each one of the members of the ring independently selected from C, N, O and S; with the proviso that X is not chromane, anthracene, a biradical of formula: <img class="EMIRef" id="491842-imgf000050-0002" /> or the compound 2,6-bis[(3,5-trihydroxybenzoyl)oxy]naphthalene. 2. The compound according to claim 1 , wherein X is selected from the group consisting of naphthalene, tetrahydronaphthalene and biphenyl, each optionally substituted with one or more groups selected from the group consisting of (Ci-C<4>)-alkyl, (Ci-C<4>)-alkoxy, nitro, halogen, NH<2>, (C<r>C<4>)-alkyl ester, CONH<2> and (Ci-C<4>)alkylamide. 3. The compound according to any of the claims 1 -2, wherein X is selected from the group consisting of naphthalene and biphenyl, each optionally substituted with one or more groups selected from the group consisting of (Ci-C<4>)-alkyl, (Ci-C<4>)-alkoxy, nitro, halogen and (Ci-C<4>)-alkyl ester. 4. The compound according to any of the claims 1 -3, wherein X is selected from the group consisting of <img class="EMIRef" id="491842-imgf000051-0001" /> being each of the ring systems optionally substituted by one or more groups selected from H, (d-C<4>)-alkyl and (d-C<4>)-alkyl ester. 5. The compound according to any of the claims 1 -3, wherein X is a biphenyl selected fro <img class="EMIRef" id="491842-imgf000051-0002" /> wherein R<1>, R<2>, R<3>, R<4> and R<5> are independently selected from the group consisting of H, (C-ι-C<4>)-alkyl, (C-ι-C<4>)-alkoxy, halogen, nitro, NH<2>, (C-ι-C<4>)alkyl ester, CONH<2> and (C<r>C<4>)alkylamide. 6. The compound according to any of the claims 1 -2, wherein X is a tetrahydronaphthalene selected from <img class="EMIRef" id="491842-imgf000052-0001" /> wherein R<1>, R<2>, R<3> and R<4> are independently selected from the group consisting of H, (C-ι-C<4>)-alkyl, (C-ι-C<4>)-alkoxy, halogen, nitro, NH<2>, (C-ι-C<4>)alkyl ester, CONH<2> and (C<r>C<4>)alkylamide. 7. The compound according to any of the claims 1 -6, wherein at least two of R<4>, R<5>, R<6>, R<7> and R<8> are hydroxyl. 8. The compound according to any of the claims 1 -7, which is selected from the following: 2,3-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (e); 1 ,3-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (f); 1 ,3-bis[(3,5-dihydroxybenzoyl)oxy]naphthalene (g); 1 ,3-bis[(3,4-dihydroxybenzoyl)oxy]naphthalene (h); 1 ,4-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (i); 1 ,4-bis[(3,5-dihydroxybenzoyl)oxy]naphthalene (j); 1 ,4-bis[(3,4-dihydroxybenzoyl)oxy]naphthalene (k); 2,6-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (I); 1 ,5-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (m); 2,5-bis[(3,4,5-trihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (o); 6-(benzoyloxy)-1 ,1 '-biphenyl-3-yl 3,4,5-trihydroxybenzoate (p); 4,4'-bis[(3,4,5-trihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (q); and 4,4'-bis[(2,6-dihydroxyisonicotinoyl)oxy]-1 ,1 '-biphenyl (r). 4,4'-bis[(3,5-dihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (s) 4,4'-bis[(3,4-dihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (t) 4'-[(3,4-dihydroxybenzoyl)oxy]-1 ,1 '-biphenyl-4-yl 4-bromo-3,5- dihydroxybenzoate (u) 4'-[(3,4-dihydroxybenzoyl)oxy]-1 ,1 '-biphenyl-4-yl 3,4-dihydroxy-5- methoxybenzoate (v) 1 ,3-bis[(4-bromo-3,5-dihydroxybenzoyl)oxy]naphthalene (w) 1 ,3-bis[(3,4-dihydroxy-5-methoxybenzoyl)oxy]naphthalene (x) 1 ,3-bis[(3,4,5-trihydroxybenzoyl)oxy]-5,6,7,8-tetrahydronaphthalene (y) 1 ,4-bis[(3,4,5-trihydroxybenzoyl)oxy]-5,6,7,8-tetrahydronaphthalene (z) 1 ,4-bis[(3,5-dihydroxy-4-methylbenzoyl)oxy]-5,6,7,8-tetrahydronaphthalene (aa) 4-[(3,5-dihydroxy-4-methylbenzoyl)oxy]-5,6,7,8-tetrahydronaphthalen-1 -yl 3,4,5-trihydroxybenzoate (bb) methyl 1 -[(4-bromo-3,5-dihydroxybenzoyl)oxy]-4-[(3,4,5- trihydroxybenzoyl)oxy]-2-naphthoate (cc) methyl 1 -[(3-hydroxybenzoyl)oxy]-4-[(3,4,5-trihydroxybenzoyl)oxy]-2- naphthoate (dd) methyl 1 -[(4-hydroxybenzoyl)oxy]-4-[(3,4,5-trihydroxybenzoyl)oxy]-2- naphthoate (ee) 9. The compound according to claim 8, which is selected from the following: 1 ,3-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (f); 1 ,3-bis[(3,4-dihydroxybenzoyl)oxy]naphthalene (h); 1 ,4-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (i); 2,5-bis[(3,4,5-trihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (o); 4,4'-bis[(3,4,5-trihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (q); 2,3-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (e); 1 ,4-bis[(3,4-dihydroxybenzoyl)oxy]naphthalene (k); 2,6-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (I); 1 ,5-bis[(3,4,5-trihydroxybenzoyl)oxy]naphthalene (m); 4,4'-bis[(3,5-dihydroxybenzoyl)oxy]-1 ,1 '-biphenyl (s); 4'-[(3,4-dihydroxybenzoyl)oxy]-1 ,1 '-biphenyl-4-yl 3,4-dihydroxy-5- methoxybenzoate (v); and 1 ,3-bis[(3,4-dihydroxy-5-methoxybenzoyl)oxy]naphthalene (x). 10. A pharmaceutical composition comprising an effective amount of a compound of formula (I) as defined in claim 1 with the proviso that X is not chromane or <img class="EMIRef" id="491842-imgf000054-0001" /> in combination with appropriate amounts of pharmaceutically acceptable diluents or carriers. 11. Use of a compound of formula (I) as defined in claim 1 with the proviso that X is not chromane or <img class="EMIRef" id="491842-imgf000054-0002" /> for the manufacture of a medicament for the prophylaxis and/or treatment of a disorder mediated by FASN and associated clinical symptoms in a human person, being such disorder selected from cancer and obesity. 12. Use according to claim 11 , wherein the cancer is selected from the group consisting of autoimmune lymphoproliferative syndrome (ALPS), chronic lymphoblastic leukemia, hairy cell leukemia, chronic lymphatic leukemia, peripheral T-cell lymphoma, small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, Burkitt's lymphoma, Epstein-Barr virus- positive T cell lymphoma, histiocytic lymphoma, Hodgkin's disease, diffuse aggressive lymphoma, acute lymphatic leukemia, T gamma lymphoproliferative disease, cutaneous B cell lymphoma, cutaneous T cell lymphoma, Sezary syndrome, acute myelogenous leukemia, chronic or acute lymphoblastic leukemia, hairy cell leukemia, sarcoma, osteosarcoma, breast cancer, squamous cell carcinoma, Epstein-Barr virus-positive, nasopharyngeal carcinoma, glioma, colon, stomach, prostate, renal cell, cervical and ovarian cancers, lung cancer, including small cell lung carcinoma, and non-small cell lung carcinoma. 13. Use according to claim 12, wherein the cancer is selected from the group consisting of breast, prostate, colon, ovary, endometrium, mesothelium, lung, thyroid, stomach and brain cancer. 14. Use according to claim 11 , wherein symptoms associated with cancer are selected from cancer-associated cachexia, fatigue, asthenia, paraneoplastic syndrome of cachexia and hypercalcemia. 15. A process for the preparation of the compounds of formula (I), as defined in claim 1 , with the proviso that X is not chromane, anthracene or a biradical of formula <img class="EMIRef" id="491842-imgf000055-0001" /> which comprises the following steps: a) reacting a dihydroxyderivative of formula (II) HO<V> OH (N) wherein X is as definec I in claim 1 ; with a carboxylic acid of formula (III) and with a carboxylic acid o1 <"> formula (IV) <img class="EMIRef" id="491842-imgf000055-0002" /> wherein Y, Z and RrR<8> are as defined in claim 1 , and Gpi and Gp<2> are each independently a hydroxyl protecting group; to give a compound of formula (V) wherein Gp-i, Gp<2>, RrRs are as defined in claim 1 ; <img class="EMIRef" id="491842-imgf000055-0003" /> b) deprotecting the compound of formula (V) to remove the protecting groups; and c) optionally converting a compound of formula (I) into its pharmaceutically acceptable salt; and/or separating a mixture of isomers of a compound of formula (I) to isolate one of such isomers substantially free from the other isomer; and/or transforming it into a prodrug thereof. 16. A kit comprising separate containers containing a pharmaceutical composition according to claim 10, and a reconstituting agent and instructions for the use of each actor in combination for the treatment or prevention of cancer.