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GB2260134A - Derivatives of poly-5-amino-3-carboxy-1-methyl compounds - Google Patents

Derivatives of poly-5-amino-3-carboxy-1-methyl compounds Download PDF

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Publication number
GB2260134A
GB2260134A GB9121205A GB9121205A GB2260134A GB 2260134 A GB2260134 A GB 2260134A GB 9121205 A GB9121205 A GB 9121205A GB 9121205 A GB9121205 A GB 9121205A GB 2260134 A GB2260134 A GB 2260134A
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Prior art keywords
methyl
bis
imino
pyrrole
carbonylimino
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GB9121205A
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GB9121205D0 (en
Inventor
Nicola Mongelli
Giovanni Biasoli
Alfredo Paio
Mariangela Mariani
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Pfizer Italia SRL
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Farmitalia Carlo Erba SRL
Carlo Erba SpA
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Priority to GB9121205A priority Critical patent/GB2260134A/en
Publication of GB9121205D0 publication Critical patent/GB9121205D0/en
Publication of GB2260134A publication Critical patent/GB2260134A/en
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D207/00Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D207/00Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D207/42Nitro radicals

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Compounds of the formula (I> <IMAGE> wherein W is =O, =S or =N-H, m and n are 1 to 4. B and B1 are a) -(CH2)p-NR1R2 wherein p is 2 to 4 and R1 and R2 @are H or C1-C6 alkyl; b) wherein q is 1 to 4, R3 is H and R4 and R5 @are H or C1-C6 alkyl; @or R3 and R4 taken together form -CH=CH-, CH2CH2- or -CH2CH2CH2- and R5 is H or C1-C6 alkyl; c) a saturated or unsaturated carbocyclic or condensed carbocyclic ring substituted by one to three basic groups; d) a saturated or unsaturated heteromonocyclic or heterobicyclic ring containing 1 to 3 O, N or S atoms and substituted by 1 to 3 @basic groups; e) a saturated or unsaturated carbocyclic or condensed carbocyclic ring containing 1 to 3 acid groups; f) a saturated or unsaturated heteromonocyclic or heterobicyclic ring containing 1 to 3 O, N or S atoms and substituted by 1 or @more acid groups; g) a pyranyl of furanyl sugar residue substituted by 1 too 3 acid groups; or h) -CH2(CHA)rCH2A wherein each A is an acid group and r is 0 to 2, and the pharmaceutically acceptable @salts thereof have activity as antiogenesis inhibitors and are useful in particular in cancer therapy, administered either alone or together with an antitumour agent. Precursors of the above compounds have the formula:- <IMAGE> or are acid addition salts thereof.r

Description

DERIVATIVES OF POLY-5-AMINO-3-CARBOXY-1-METHYL COMPOUNDS The present invention relates to new derivatives of substituted carboxy pyrroles, to a process for their preparation and to a pharmacological composition containing them.
The present invention provides new compounds having the following general formula (I)
wherein W is =0, =S or =N-H each of m and n, being the same or different, is an integer of 1 to 4; each of B and B1, which may be the same or different, is either a group chosen from: a) a -(CH2) -NE1R2 group, wherein p is an integer of 2 to 4 and each of R1 and R2, independently, is hydrogen or C1-C6 alkyl;
group, wherein is an integer of 1 to 4; R3 is hydrogen and each of R4 and R5, independently, is hydrogen or C1-C6 alkyl; or R3 and 4, taken together, form a -CH=CH-,-CH2-CH2- or -CH2-CH2-CH2 chain, and R5 is hydrogen or C1-C6 alkyl; c) a saturated or unsaturated, carbocyclic or condensed carbocyclic ring substituted by one to three basic groups; d) a saturated or unsaturated, heteromonocyclic or hetero bicyclic ring, containing one to three heteroatoms chosen from nitrogen, oxygen and sulphur, substituted by one to three basic groups; or a group chosen finn: e) a saturated or unsaturated, carbocyclic or condensed carbocyclic ring substituted by one to tree acid groups; f) a saturated or unsaturated, heteromonocyclic or hetero bicyclic ring, containing one to three heteroatoms chosen from nitrogen, oxygen and sulphur, substituted by one or more acid groups; g) a pyranyl or furanyl sugar residue substituted by one to three acid groups; or h) a -CH2(CEA)CH2A group, wherein each A group, being the same or different, is an acid group and r is 0, 1 or 2; and the pharmaceutically acceptable salts thereof.
An alkyl group may be a branched or straight alkyl group.
A C1-C6 alkyl group is preferably a C1-C4 alkyl group.
A C1-C4 alkyl group is preferably methyl, ethyl, propyl or isopropyl.
When two or three basic or acid groups are present on the same B Gr B1 substituent, whey may be the same or different.
When in a -(CH2)p-, (CH2)@ or -(CH2)r-group p and/or q and/or r is higher than 1, the alkylene chain, thus provided, may be a branched or straight alkylene chain.
When B or B1 is a ring as defined above under c) and e), it is for example phenyl or naphthyl, in particular naphthyl.
When B or B1 is a ring as defined above under d) and f), it is for example thiazole, pyridine,pyrimidine, pyrazine, pyridazine, tetrahydropyran or tetrahydrofuran; in particular thiazole, pyrimidine or tetrahydropyran. When B and B1 are a sugar residue as defined above under g) they are for example a residue deriving from glucose or ribose.
Examples of basic groups,according to the definitions of B and B1, given above under c) and d), for instance may be those chosen from -(CH2)s-NR6R7, in whichs is zero or an integer of I to 4 and each of R6 and R7, independently, is hydrogen or C1-C6 alkyl;
in which s is as defined above, R8 is hydrogen and each of Rg and R10, independently, is hydrogen or C1-C6 alkyl, or R8 and Rg, taken together, form a -CH=CH-, -CH2-CH2- or -CH2-CH2-CH2 - chain and R10 is hydrogen or C1-C6 alkyl;and
wherein R8, R9 and R10 are as defined above.
Examples of acid groups according to the definition of B and B1 groups given above under e), f), g) and h) for instance may be those chosen from the group including sulfonic, sulfuric, sulfamic, sulfinic, phosphoric, phosphonic, phosphamic or carboxylic acid groups, i.e. S03 H, S04 H, S03 NH2, SO2 H, P04 H2, P03 H2, P03 NH3 and C02 H.
As already said, the invention includes within its scope also the pharmaceutically acceptable salts of the compounds of formula (I).
The pharmaceutically acceptable salts of the compounds of flrmula (I) include both those formed with an inorganicacide.g.nitric acid, hydrochloric acid or sulphuric acid, or with an organic acid, e.g; citric, malic, maleic, mandelic, tartaric, fumaric or methanesulphonic acid, and those with inorganic bases, sucn as sodium, potassium, calcium and aluminium hydroxides, or with organic bases, such as lysine, arginine, N-methyl-glucamine, triethylamine, triethanolamine, dibenzylamine, methylbenzylamine, di-(2-ethyl-hexyl)-amine, piperidine, N-ethylpiperidine, N,N-die thylaminoethylamine, N-ethylmorpholine, ss-phene- thylamine, N-benzyl-ss-phenethylamine, N-benzyl-N,N-dimethyl amine and the other acceptable organic amines.
The present invention also includes within its scope pharmaceutically acceptable bioprecursors (otherwise known as pro-drugs) of the compounds of formula (I), i.e. compounds which have a different formula to formula (I) above, but which nevertheless upon administration to a human being are ccnverted directly or indirectly in vivo into a compound of formula (I).
Preferred compounds according to the present invention are the compounds of formula (I), wherein each of m and n, being ,.
the same, is 2 or 3; W is as defined above, each of B and B1 which are the same or different, is either a group chosen from wherein R2 wherein p is 2 or 3 and each of R1 and b;2 independently is hydrogen or C1-C alkyl;
wherein q is 2 or 3 ;R3, R4 and R5 are each hydrogen or R3 and R4, together, form a -CH2-CH2-, -CH=CH or -CH2-CH2-CH2- chain and R5 is hydrogen; c') a ptienyl or naphthyl group substituted by one. two or three basic groups chosen independently from
in wllicit s is as defined above and each of R6and R7, independen@ly. is hydrogen or C1-C4 alkyl, or d') a thiazole, pyrimidine or tetrahydropyranyl ring substituted by one, two or Lhree basic groups, as defined above under c'); or a group chosen from : e') an unsaturated carbocyclic or condensed carbocyclic ring substituted by 1 to 3 acid groups; f) a tetrahydropyranyl or tetrahydrofuranyl rin & BR< substituted by 1 to 3 acid groups; or g' ) a glucoseruranosyl residue substituted by 1 to 3 acid groups; and the pharma ceutically acceptable salts thereof.
Specific examples of preferred compounds of the invention, are the followings: 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl imino(N-methyl-5,3-nyrrole)carbonylimino))-bis(N-methyl -5,3-pyrrolecarbonylmino(3-propionamidine)); 4,4'-(1,3-guanidine-bis-(N-methyl-5,3-pyrrolecarbonyl imino(N-methyl-5,3-pyrrole)carbonylimino))-bis(N-methyl 5,3-pyrrolecarbonylimino(3-propionamidine)); 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3 -pyrrole)carbonylimino) )-bis( 1-naphthaleneamine -N,N-dimethyl); 4,4'- ( carbonyl-bis ( irnino-N-methyl- 3 -pyrrolecarbonyl - imino(N-methyl-5,3 -pyrrole)carbonylimino) )bis( 1naphthalen- sulfonic acid); 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino(N-methyl-5,3-pyrrole)carboyliminb))bis(1-naphthalensulfonic acid); 8,8'-(carbonyl-bis(imino-N-methyl- 5,3-pyrrolecarbonyl-imino (N-methyl- 5,3-pyrrole)carbonylimino) )bis( 1,3-naphthalendisulfonic acid); 4,4'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3'-pyrrole)carbonylimino))bis(1,7-naphthalendisulfonic acid); 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3 spyrrole)carbonylimino))bis( 1,5-naphthalendisulfonic acid): 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)arboylimino))bis(1,3,5-naphthalentrisulfonic acid):: 8,8'-(carbonl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3,6-naphthalentrisulfonic acid); 7,7' -(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3-naphthalendisulfonic acid); 6,6'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3-naphthalendisulfonic acid); 3,3'-(carbonyl-bis(imino-N-methyl- s,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,7 naphthalendi sulfonic acid); 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3 -pyrrole)carbony2imino) )bis(2,7 -naphthalendi sulfonic acid);; 7,7' (carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonlimino))bis(1,3,5-naphthalentri sulfonic acid); 7,7'-thiocarbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bisk1,3 - naphthalendi sulfonic acid); 2,2'-(carbonyl-bis(imino-N-methyl- 5,3 pyrrolecarbonyl-imino (N-methyl-5,3-pirrole)carbonylimino))bis(2-deoxy-D-glucose6-sulphate); and 2,2' (carbonyl-bis(imino-N-methyl 5,3 -pyrrolec arbonyl- imino (N-methyl- 5,3 pyrrole)carbonylimino))bis(2-deoxy-D-glucose 6-phosphate); and the pharmaceutically acceptable salts thereof.
It has to be noticed that the compounds of the present invention according to IUPAC should be termed as "N-methyl-2,4-pyrrolecar- bonyl-imino" compounds, however for convenience's reasons they are herein termed as "N-methyl-5,3-pyrrolecarbonyl-imino" compounds.
The compounds of formula (I), and the salts thereof, can be prepared by a process comprising: a) reacting a compound of formula (II)
wherein n and B1 are as defined above, or a salt thereof, with a compound of formula (III)
wherein W' is =O or =S, and each of the X groups, which may be the same or different, is a leaving group, so as Lo obtain a compound of formula (I), in Which W is =O or =S, m and n are the same and B and B1 are the same; or b) reacting a compound of formula (IV), or a salt thereof,
wherein fl. X, W and m are as defined above, with a compound of formula (II). as defined above, so as to obtain a compound of formula (r) wherein W is =O or =S; or c) reacting a compound of formula (V), or a salt thereof,
wherein ss and m are as defined above, with a compound of formula (II), as defined above. so as to obtain a compound of formula (I), wherein W is =Nfl; and if desired, salifying a compound of formula (I) thus obtained; and/or if desired, obtaining a free compound of formula (I) from a salt thereof.
A salt of a compound of formula (II), (IV) and (V) may be either a salt with organic or inorganic acid or a salt with inorganic bases, for example those mentioned above as to the pharmaceutically acceptable salts of the invention, the hydrochloride and hydrobromide salts or the sodium and the potassium salts being the preferred.
Preferred examples of good leaving groups, according to the meaning of X, are halogen atoms, in particular chlorine, or other easily displaceable groups such as, imidazolyl, triazolyl, p-nitrophenoxy, trichlorophenoxy or trichloromethyloxy.
The reaction of a compound of formula (II), or a salt thereof with a compound of formula (III) is an analogy process and can be carried out according to well known methods; for example according to the conditions described in organic chemistry for this kind of reaction, i.e. for synthesis of urea derivatives. Preferably when in a compound of formula (III) X is an halogen atom, e.g. chlorine, the reaction may be carried out at a molar ratio of compound (II), or a salt thereof: compound (III) from about 1:1 to about 1:4.
The reaction is preferably performed in organic solvents such as dimethylsulphoxide, hexamethylphosphotriamide, dimethylacetamide or, preferably, dimethylformamide,or their aqueous mixtures, or in water/dioxane or water/toluene mixtures, in the presence of either an organic base such as triethylamine or diisopropylethylamine, or an inorganic base such as sodium bicarbonate or sodium acetate.
The reaction temperature may vary from about -100C. to about 500C. and the reaction time about 1 to about 12 hours.
The reaction of a compound of formula (IV), or a salt thereof, with a compound of formula (II), and the reaction of a compound of formula (V), or a salt thereof, with a compound of formula (II), respectively, can be performed by following the same procedure described above as to the reaction of a compound of formula (II), or a salt thereof, and a compound of formula (III). In particular the reaction temperature may range from room temperature to about 900 C.
The compounds of formula (I) prepared according to the above described procedures may be purified by conventional methods such as by silica gel or alumina column chromatography, and/or by recrystallization from organic solvents such as lower aliphatic alcohols or dimethylformamide.
Analogously salification of a compound of formula (I) can be carried out by known methods in the art.
The compounds of formula (II) may be obtained according to known procedures.
For instance, a compound of formula (II) may be obtained by reduction of a compound of formula (VI)
wherein n and B1 are as defined above by methods well known in the art. The compounds of formula (VI) may be obtained by reacting an amine of formula B1-NH2, where B( is defined as above, with a compound of formula (VII)
wherein n and X are as defined above.
Also the reaction of an amine of formula B1-NH2 with a compound of formula (VII) is a well known process.
Alternatively a compound of formula (VI) whereinnis 2 or 3 may be obtained by a multi-step-process comprising reacting a compound of formula (VIII)
wherein X is as defined above, with an amine of formula B1-NH2, in which B1 is as defined above. The reaction, which may be carried out according to known methods, provides compounds of formula (IX)
wherein B1 is as defined above.
A compound of formula (IX) is reduced according to known methods to provide a compound of formula (X)
wherein B1 is as defined above, which in its turn is reacted with a compound of formula (VIII), as defined above, thus obtaining a compound of formula (VI), as defined above1 wherein n is 2. If a compound of formula (VI), wherein n is 3 is desired, a further reduction and acylation step is required.
The compounds of formula (VIII) may be obtained from a product of formula (XI)
according to well known methods of carboxylic acid activation.
The compound of formula (XI) is a new compound and it may be obtained from a product of formula (XII) prepared as in Tetrahedron Vol.27 pp 245-353,1971, K.J.Morgan, D.P.Morrey
through the conventional N-alkylation methods of heterocyclic compounds, bearing an acidic hydrogen atom attached to nitrogen, and the following hydrolysis of methyl ester.
The compounds of formula (?CI ) and the amine of formula B-NH2 are known products or may be easily obtained according to known methods.
The compounds of formula (IV) may be obtained by reaction of a compound of formula
wherein m and B are as defined above, with an excess of the compounds of formula (III). The compounds of formula (XI:)may be prepared analogously to the compound of formula (II).
The compounds of formula (III) are commercially available products. The compounds of formula (V) may be obtained by reaction of a compound of formula (XI-I)as defined above with a compound of formula (on'), X-C-N (XIV) wherein X is as defined above, in particular chlorine or bromine.
Also compounds (XIV) are commercially available products.
When in the intermediate products, herein described, groups are present which may interfere with the reaction, such groups are protected in a conventional way before the reaction takes place and then are deprotected at the end of the reaction, according to well known methods, typical protecting groups may be those used in the chemistry of peptides.
PHARMACOLOGY The compounds of the invention have been found to be active as angiogenesis inhibitors.
By angiogenesis inhibitor is meant an agent capable of suppressing the growth of new blood vessels. Therefore the compounds of the present invention are useful in treating several pathological conditions in mammals, including humans, where the growth of new blood vessels is detrimental, for example in chronic inflammation, diabetic retinopathy, psoriasis, rheumatoid arthritis and tumour growth.In particular, in cancer therapy the compounds of the invention can be administered alone or in a combined method of treatment with antitumor agents a A further object of the present invention is a combined method of treatment of cancer in mammals, including humans, in need of such treatment, said method comprising administering 1) a compound of formula (I ),cra pharmaceutically acceptable salt thereof, and 2) an antitumor agent, in amounts and close enough together in time sufficient to effect a therapeutically useful interaction.
Object of the present invention is also to provide products containing a compound of formula (I ), or a pharmaceutically acceptable salt, and an antitumor agent as a combined preparation for simultaneous, separate or sequential use in anti-cancer therapy.
The term "ant tumor agent" is meant te comprise both a single antitumor drug and cocktails" i.e. a mixture of such drugs, according to the clinical practice.
Antitumor agents that can be formulated with a compound of the invention or alternatively, can be administered in a combined method of treatment are e.g. doxorubicin, daunomycin, epirubicin, idarubicin, etoposide, fluorouracyl, mephalan, cyclophosphamide, bleomycin, vinblastin and mitomycin or a mixture of two or more thereof.
The compounds of the invention can therefore be used in particular with an antitumor agent, for example an anthra-cycline glycoside such as doxorubicin, daunorubicin, epirubicin or idarubicin as mentioned above, in a treatment to ameliorate or improve the conditions of a patient suffering from cancer.
A compound of the invention and an anti tumor agent such as an anthracycline glycoside can be for instance administered to improve the conditions of a patient having a leukaemia such as myeloblastic leukaemia, linphoma, sarcoma, Wilm's tumor, malignant neoplasm of the bladder, breast, lung or thyroid.
The angiogenesis inhibitor activity of the compounds of the present invention is shown e.g. by the fact that they have been found to be active in the chorioallantoic membrane test, according to the Folkmans method Nature, 279, 307 (1982). The compounds of the invention can be administered by the usual routes, for example, parenterally, e.g. by intravenous injection or infusion, intramuscularly, subcutaneously, topically or orally. The dosage depends on the age, weight and condition of the patient and on the administration route.
For example, a suitable dosage for administration to adult humans may range from about 0.5 to about 100 mg pro dose 1-4 times a day.
Object of the present invention are also pharaceutical compositions nG h compound of formula (I) or a pharmaceutically acceptable salt thereof as the active substance, in association with one or nore pharmaceutically acceptable excipients and/or carriers.
The pharmaceutical compositions of the invention are usually prepared following conventional methods and are administered in a pharmaceutically suitable form.
For instance, solutions for intravenous injection or infusion may contain as carrier, for example, sterile water or preferably, they may be in the form of sterile aqueous isotonic saline solutions.
Suspensions or solutions for intramuscular injections may contain, together with the active compound, a pharmaceutically acceptable carrier, e.g. sterile water, olive oil, ethyl oleate, glycols, e.g. propylene glycol, and if desired, a suitable amount of lidocaine hydro chloride.
In formulations for topical application, e.g. creams lotions or pastes for use in dermatological treatment, the active ingredient may be Mixed with conventional olcaginous or emulsifying excipients.
The solid oral forms, e.g. tablets and capsules, may contain, together with the active compound, diluents, e.g. lactose, dextrose, saccharose, cellulose, corn starch and potato starch; lubricants, e.g. silica, talc, stearic acid, magnesium or calcium stearate, and/or polyethylene gly ols; binding agents, e.g. starches, arabic gums, gelatin, methylcellulose, carboxymethyl cellulose, polyvinylpyrrolidone; disaggrega ting agents, e.g. a starch, alginic acid, alginates, sodium starch glycolate; effervescing mixtures; dyestuffs; sweeteners; wetting agents, for instance, lecithin, polysorbates, lauryl sulphates: and, in general, non-toxic and pharmacologically inactive substances used in pharmaceutical formulations.Said pharmaceutical preparations may be manufactured in a known manner, for example by means of mixing, granulating, tabletting, sugar-coating, or film-coating processes.
Furthermore,according to the invention there is provided a method of treating pathological conditions where the growth of new blood vessels is detrimental, for example chronic in'1a.-.r.ation, diabetic retinopathy, psosiaris, rheumatoid arthritis and tumors, in mammals in need thereof including humans, comprising administering to the said mammals a composition of the invention.
The following examples illustrate but do not limit the invention.
Example 1 B,B'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-pyrrole)carbonylimino))-bis(l-naphthaleneamine-N,N-dimethyl).
To a solution of ss-(amino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl- 5,3-pyrrole)carbonylimino) (l-dimethylaminonaphtha lene)-hydrochloride( 750 mg, 1,48 :nmols) in N,N-dimethylformamide (50 ml), trietylamine (0,39 ml, 2,96 mmols) is added under stirring. A solution of 1,1'-carbonyldiimidazole (1,23 mg, 0,74 mmols) in N,N'-dimethylformamide (15 ml) is added dropwise, in half an hour, at room temperature. The solution is stirred for 1 hr, then is evaporate under vacuum to dryness. The residue is taken up with methanol (30 ml), stirred for 1 hr and filtered.
The methanolic solution is evaporated and the residue is chromatographed o a silica gel column with ethyl acetate: methanol 20 : 10 as eluent, affording 260 mg of the title compound, The title compound was characterised as follows: N.M.R. (DMSO): 6 ppm 2.90 (6H,s); 3.82 (3H,s); 3.98 (3H,s); 6.80 t 7.30 (4H, 4d); 7.45 + 7.82 (5H,m); 8.20 (lH, bs); 8.80 (lH, dd); 10.08 (1H, bs); 11.28 (1H, bs).
F.A.B. - M.S.: M/g 887 [M+H]+; 702 [M-185]+; 430.
By analogous procedure the following compounds can be obtained: 8,8'-Thiocarbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-prrole)carbonylimino))-bis(1-naphthaleneamine -N,N-dimethyl); 5,5'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-pyrrole)carbonylimino))-bis(1-naphthaleneamine-N,N -dimethyl); 5,5'-(thiocarbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-pyrrole)carbonylimino))-bis(1-naphthaleneamine -N,N-dimethyl); 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-53 -pyrrole)carbonylimino) )-bis(1,8-naphthalene- diamine-N,N,N',N'-tetramethyl); 4,4'-(thiocarbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonylimino(N-methyl-5,3-pyrrole)carbonylimino))-bis(1,8-naphthalene -diamine- N,N,N' 1N'-tetramethyl); 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-s,3-pyrrole)carbonylimino))-bis(1-phenyleneamine- -N,N-dimethyl); 3,3-(thiocarbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl- 5,3-pyrrole)carbonylimino))-bis(l-phenyleneamine- N,N-dimethyl); 2,2'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-pyrrole)carbonylimino))-bis(4-thiazoleamine- -N,N-dimethyl));; 2,2'-(thiocarbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-s,3-pyrrole)carbonylimino))-bis(4-thiazoleamine-N,N- -dimethyl); 4.4'-(carbonyl-bis(imino-N-methyl- 5, 3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))-bis(N-methyl-5,3- pyrrolecarbonylmino(3-propionamidine)); and 4,4'(1,3guanidine-bis-(N-methyl-5,3-pyrrolecarbonyl-imino(N-methyl 5,3-pyrrole)carbonylimino))-bis(N-methyl-5,3- pyrrolecarbonylimino(3-propionamidine)).
Example 2 8-(Amino-N-methyl-5,3-pyrrolecarbonylimino(N-methyl-5,3- pyrrole)carbonylimino)(l dimethylaminonaphthalene) dihydrochloride.
The compound 8-(nitro-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-pyrrole)carbonylimino)(l dimethylaminonaphtha-lene):(650mg = 1.41 mmoles) is dissolved into a mixture of water (50 ml), dioxane (200 ml) and 2N HC1 (2,5 ml) and reduced over a Pd catalyst (5% on carbon; mg 200) under H2 pressure (40 p.s.i.) for 4 hours.
The catalyst is filtered and the resulting solution is concentrated in vacuum to dryness, affording 600 mg of the title compound.
Example 3 8-(nitro-N-methyl-5,3-pyrrolecarbonyl-imino(N-methyl-5t3 pyrrole)carbonylimino)-l-dimethylaminonaphthalene.
To a solution of 8-(amino-(N-methyl-5,3 pyrrole) carbonylimino) (1- dimethylaminonaphthalene)dihydrochloride (820 mg, 2.15 mmols) in dioxane (50 ml), water (20 ml) and triethylamine (0,9 ml, 6,4 mmols) is added dropwise under stirring at room temperature, a solution of (5-nitro-N-methyl-3,pyrrole) carbonyl chloride (407 mg, 2,15 mmols) in dioxane (15 ml).
The mixture is stirred 1 hr at room temperature and then evaporated under vacuum to dryness.
The residue is treated with methanol (30 ml), stirred for half an hour and filtered, to obtain the title compound (730 mg).
The title compound was characterised as follows: N.M.R. (DMSO): 6 ppm 3.82 (6H,s); 6.80 . 7.40 (4H,4d); 7.90 (1H, d); 8.80 (1H, d); 8.05 (1H, bs); 8.60 (1H, d); 9.33 (lH,d); 9.90 (1H, bs); 12.30 (lH, bs).
F.A.B. - M.S.: M/Z 1411 [M-H]-; 1389 [M-Na]'; Example 4 8-(amino(N-methyl-5,3-pyrrole)carbonylimino)(l-dimethyl= aminonaphthalene)dihydrochoride.
To a solution of 8-(nitro(N-methyl-5,3 pyrrole) carbonylimino) -l-dimethylaminonaphtalene (900 mg, 2.63 mmols) in dioxane (90 ml), water (10 ml) and 2N HCl (4,15 ml) is reduced over a Pd catalyst (5% on carbon, 400 mg) under H2 pressure (40 p.s.i.) for 2 hr.
The catalyst is filtered and the resulting solution is concentrated in vacuum to dryness, affording 810 mg of the title compound.
Example 5 8- (nitro (N-methyl-S, 3-pyrrole) carbonylimino) -l-dimethyl= aminonaphthalene.
To a solution of 8-(nitro(N-methyl-5,3 pyrrole) carbonylimino) -l-aminonaphthalene (760 mg, 2,45 mmols) in acetonitrile (10 ml), a 40% solution of formaldehyde in water (1.84 ml, 24,5 mmols) and sodium cyanoborohydride (465 mg, 735 mmols) are added under stirring at room temperature. Glacial acetic acid (0,37 ml), diluted with acetonitrile (5 ml), is added over 10 minute, and the reaction mixture is stirred at room temperature for 2 hrs.
An additional 0.37 ml of glacial acetic acid is added, and stirring is continued for 30 minutes more. The reaction mixture is poured into ethyl acetate (120 ml) and then washed with three 20-ml portions of 1N NaOH.
The organic solution is dried (Na2S04) and evaporated in vacuum to dryness. Crystallization from 95% ethanol afforded the title compound (490 mg).
Example 6 8-Nitro(N-methyl-5,3-pyrrole)carbonylimino)-1-aminonaphthalene To a solution of 1,8-diaminonaphthalene(2,35 g, 14,87 mmols), in dioxane (150 ml), triethylamine (2,35 ml, 14,87 mmols) is added under stirring. A solution of !5-nitro-N-methyl-3-pyrrole) carbonyl chloride (2,8 g, 14,87 mmols) in dioxene (50 ml) is added dropwise, in 1 hr, at room temperature.
The mixture was stirred 2 hrs, then the reaction mixture is evaporated under vacuum to dryness. The residue is treated with water (300 ml) stirred for half an hour and filtred to obtain the title compound (3,64 g).
Example 7 5-nitro-N-methyl-3-pyrrole methyl carboxylate.
To a solution of 18-crown-6-(0,8 g, 3 mmols) in diethyl ether (50 ml), potassium tert. butoxide (3,9 g, 35 mmols) is added under stirring. After 30 minutes 5-nitro-3-pyrrole methyl carboxylate (4,68 g, 30 mmols) is introduced in a single portion, and stirring is continued for 15 minutes.
A solution of methyl iodide (4,97 g, 35 mmols) in diethyl ether (20 m1) is added dropwise in 30 minutes, at room temperature to the reaction mixture. The solution is stirred for 2 hrs, then water (20 ml) is added, the layers are separated, and the acqueous layer is extracted with ether (40 ml). The combined organic phases are dried over anhydrous sodium sulphate. The solvent is removed under vacuum, and the residue afforded after recrystallization the title compound (3,56 g).
Example 8 5-nitro-N-methyl-3-pyrrole carboxylic acid.
To a suspension of 5-nitro-N-methyl-3-pyrrole methyl carboxylate (1 g) in ethanol (40 ml), a solution of sodium hydroxyde (800 mg) in water (40 ml) was added and the mixture was boiled under reflux until a clear solution was obtained.
The solution was cooled, filtered and the filtrate was acidified with 6N HCl; a white precipitate was formed, which was filtered off to obtain the title compound (920 mg).
Example 9 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino(N methyl-5,3-pyrrole)carbonylimino))bis(1,3,5-naphthalentrisulfonic acid) hexasodium salt.
To a solution of 8-(amino-N-methyl-5,3 -pyrrolecarbonyl-imino(Nmethyl-5,3-pyrrole)carbonylimino))(1,3,5-naphthalentrisulfonic acid trisodium salt) hydrochloride (2. 55 g, 3,5mmols) in water (60 ml) and dioxane (15 ml), sodium acetate (l.15 g, 14 mmols) was added under stirring. The whole was cooled to SOC with an ice bath, then a ~ solution of bis(trichloromethyl)cartonate (692 mg 2,33 mmols) in dioxane (10 ml) was added dropwise in 1 hr.
The mixture was stirred 2 hrs at # 8 C.
The solvents were evaporated under vacuum and the residue was taken up with methanol.
After filtration of the salts, the filtrate was evaporated and the residue was cromotographed on a silica gel column with methylene chloride: methanol: water 60:40:4 as eluent, affording g 0. 92 of the title compound.
By analogous procedure the following compounds can be obtained: 8-8'-(carbonyl-bis(imino-N-methyl-s,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,4,6-naphthalentrisulonic acid) hexasodium salt; 8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2,4,6-naphthalentrisulfonic acid) hexasodium salt; 8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3,6-naphthalentrisulfonic acid) hexasodium salt; 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2,3,5-naphthalentrisulfonic acid) hexasodium salt 8,8'-(carbonyl-ois (imino-N-mehyl-5,3-pyrrole-ca@@@@@@@@@@ (N-methyl- 5,3-pyrrole)carbonylimino) )bis( 3-naphthalensulfonic- acid)dlsodium salt; 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino(N methyl-5,3-pyrrole)carbonylimino))bis(2,7-naphthalendisulfonic acid) tetrasodium salt.
8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-S,3 -pyrrole)carbonylimino) )bis(l-naphthalensulfonic acid) disodium salt; 4,4' -(carbonyl-bis(imino-N-methyl- 5,3 pyrrolecarbonyl-imino (N-methyl- 5,3pyrrole)carbonylimino) )bis( l-naphthalensulfonic acid) disodium salt; 8,8|-(carbonyl-bis(imino-N-methyl--s,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3-naphthalendisulfonic acid) tetrasodium salt; 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino(Nmethyl-5,3-pyrrole)carbonylimino))bis(1,7-naphthalendisulfonic acid) tetrasodium salt; 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino(Nmethyl-5,3-pyrrole)carbonylimino))bis(1,6-naphthalendisulfonic acid) tetrasodium salt; 8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino(Nmethyl-5,3-pyrrole)carbonylimino))bis(2,4-naphthalendisulfonic acid) tetrasodium salt; 4,4' -(arbonyl-bis(imino-N-methyl- s,3-pyrrolecarbonyl-imino(N- methyl-5,3 -pyrrole)carbonylimino) )bis(2,5 naphthalendisulfonic acid) tetrasodium salt; and 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino(Nmethyl-5,3 pyrrole)carbonylimino))bis(2,6-naphthalendisulfonic acid) tetrasodium salt.
Example 10 8-(Amino-N-methyl-5,3 pyrrolecarbonyl-imino(N-methyl-5,3-pyrrole) carbonylimino))(1,3,5-naphthalentrisulfonic acid trisodium salt) hydrochloride.
The compound 8-(nitro-N-methyl-5,3-pyrrolecarbonyl-imino(N-methyl5,3-pyrrole)carbonylimino))(1,3,5-naphthalentrisulfonic acid trisodium salt) (2.17 g = 3 mmols) was dissolved into a mixture of water (120 ml) and 1N HCl (3 ml) and reduced over a Pd catalyst (10% on carbon; mg 900) under H2 pressure (50 p.s.i.) ,,.
for 3 hours.
The catalyst was filtered and the resulting solution was concentrated in vacuum to dryness, affording 2,1 g of the title compound.
Example 11 8(Nitro-N-methyl-5,3-pyrrolecarbonyl-imino(N-methyl-5,3-pyrrole) carbonylimino))(1,3,5-naphthalenetrisulfonic acic trisodium salt) To a solution of 8-(amino(N-methyl- 5,3 pyrrole)carbonylimino) (1,3,5-naphthalentrisulfonic acid trisodium salt)hydrochloride (.2,43 g, 4mmols) in water ( 50 ml) and 1N NaOH(1,34 ml), sodium acetate (0,656. g, 8 mmols) was added under stirring.
The solution was cooled at 50C with an ice bath, then a solution of (-5-nitro-N methyl-3.pyrroie) carbonyl chloride (0,754 g, 4 mmols) in dioxane (30 ml) was added dropwise in 1 hr. The mixture was stirred 1 hr at 50C, acidified at pH 4 with 1N HCl and evaporated under vacuum to dryness. The residue was treated with ethyl acetate (400 ml), stirred for 1 hour and filtered, to obtain the title compound (2,81) Example 12 8-(amino(N-methyl-5,3 -pyrrole)carbonylimino)(1,3,5-naphthalen .trisulfonic acid trisodium salt), hydrochloride.
The splution of 8-(nitro(N methyl-5,3-pyrrole)carbonylimino) (1,3,5-naphthalentrisulfonic acid trisodium salt)(l.B03 g 3 mmols) in water (120 ml) and lNHCl (3 ml) was reduced over a Pd catalyst (1OX on carbon g 800) under H2 pressure (50 p.s.i.) for 4 h.
The catalyst was filtered and the resulting solution was concen trated in vacuum to dryness, affording 1.8 g of the title compound.
Example 13 8-(nitro(N-methyl-5,3-pyrrole) carbonylimino)(1,3,5-naphthalentrisolfonic acid trisodium salt).
To a sclution of 8-amino, 1,3,5-naphthalentrisulfonic acid trisodium salt (1,347 g 9 3 mmols) in water (45 ml), sodium.
acetate (0.492 g = 6 mM) was added under stirring. The solution was cooled at 5'C with an ice bath, then a solution of (5 nitro- N-methyl-3-pyrrole)carbonyl chloride (0.943 = 5 mmols) in dioxane (45 r.l) was added dropwise in 1 h. The mixture was stirred 3 h at 5 C, acidified and pH 4 with iN HCl and evaporated under vacuum to dryness.
The residue was treated with ethylacetate (300 ml), stirred for 1 hour and filtered, to obtain g 1.7 of the title compound.
Example 14 7,7'-(carbcnyl-bis(imino-N-methyl--5,3-pyrrolecarbonyl~imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3-naphthalendisulfonic acid) tetrapotassium salt.
To a sclution of 7-(amino-N-methyl-5,3 -pyrrolecarbonylimino(N methyl-5.3-pyrrole)carbonylim.ino))(1,3-naphthalendlSulfonic acid dipotassium salt) hydrochloride (200 mg, 0.3 mmols) in water (23 ml) and dioxane (15 ml), potassium acetate (118 mg, 1,2 mmols) was added under stirring. A , solution of bis (trichloromethyl)carbonate (44.5 mg, 0.15 mmols) in dioxane (5 ml), was added dropwise in half hr at room temperature.
The mixture was stirred 1 hr. at room temperature.
The solvents were evaporated under vacuum, the residue was cromatographed on a silica gel column with methylene chloride:methanol:water 40:60:6 as eluent, affording 115 mg of the title compound.
The title compound was characterised as follows: N.M.R. (DMSO): 6 p.p.m. 3.85 (3H, s); 3.88 (3H, s); 6.80 + 7.30 (4H, 4d); 7.88 (2H, m); 8.02 (1H, d); 8.20 (lH, d); 8.60 (lH, bs); 8.95 (1H, bs); 9.85 (1H, bs); 10.22 (1H, bs).
F.A.B. - M.S. M/Z 1273 [M+H]+; 1311 [M+K]+ By analogous procedure the following compounds can be obtained: 7,7'-carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino(Nmethyl-5,3 pyrrole)carbonylimino))bis(l-naphthalensulfonic acid)disodium salt; 7,7'-(carbonyl-bis (imino-N-methyl-S, 3-pyrrolecarbonyl-imino (N-methyl-5,3 pyrrole) carbonylimino) ) bis (2-naphthalensulfonic acid) disodium salt; 6,6'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3- pyrrole)carbonylimino))bis(2-naphthalensulfonic acid) disodium salt; 6,6'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1-naphthalen- sulfonic acid) disodium salt; 6,6'-(Carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2,3-naphthalendisulfonic acid) tetrasodium salt; 6,6'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3-naphthalen- disulfonic acid) tetrasodium salt; 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,5-naphthalendisulfonic acid) tetrasodium salt; 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,6-naphthalen disulfonic acid) tetrasodium salt; 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,7 -naphthalen disulfonic salt; 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3 -pyrrole)carbonylimino) )bis(2,S -naphthalen disulfonic acid) tetrasodium salt; 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2,6-naphthalendisulfonic acid) tetrasodium salt; 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl- 5,3-pyrrole ) carbonyl imino ) )bis(2,7-naphthalen- disulfonic acid) tetrasodium salt; 7-7'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3,5-naphthalen- trisulfonic acid) hexasodium salt; 7,7'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,4,6-naphthalen trisifonic acid) hexasodium salt; 7,7'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3 -pyrrole)carbonylimino))bis(1,3,6-naphthalen- trisulfonic acid) bexasodium salt; 7,7-(carbonyl-bis(imino-N-methyl-5,3-pyrrole-carbonyl-imino (N-methyl- 5,3-pyrrole)carbonylimino))bis(2,4,6-naphthalen- trisulfonic acid) hexasodium salt; 7,7'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2,3,5-naphthalen trisulfonic acid) hexasodium salt; 2,2'-(carbonyl-bis(imino-N-methyl- 5,3-pyrrolecarbonyl-imino (N-methyl- 5,3-pyrrole )carbonylimino) )bis( 2-deoxy-D-glucose 6-sulfate) disodium salt; 2,2'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2-deOxy-D-glucose- 6-phosphate) disodium salt;; 5,5'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolcarbonyl-imino (N-methyl-S,3-pyrrole)carbonylimino) )bis(8-quinolinesulfonic acid) disodium salt; 5,5'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl- 5,3-pyrrole)carbonylimino) )bis(6-quinolinesulfonic acid) disodium salt; 8,8'-(carbonyl-bis(imino-N-methyl- 5,3-pyrrolcarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(5,7-quinoline disulfonic acid) tetrasodium salt; 5,5'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl- S,3-pyrrole)carbonylimino) )bis(6,8-quinoline disulfonic acid) tetrasodium salt; 4,44-(carbonyl-bis(imino-N-methyl- S,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,5-naphthalendisulfonic acid); and 7,7'-thiocarbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imin@ (N-methyl-5,3-pyrrole)carbonylimino))bis;1,3 1,3 -naphthalendi- sulfonic acid), Example 15 8,8'-crbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3,5-naphthanentrisulfonic acid).
A solution of 8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrole carbonyl-imino(rI-mehyl-5,3 .pyrrole)carbonylimino) )bis (1,1,5-naphthalentrisulfonic acid)hexasodium salt (400 mg) in water (10 ml), is chromatographed on an Amberlite 1R-120(H) column (20 ml), with water as eluent.
The solution is evaporated to dryness in vacuum, affording 0,3 g of the title compound.
Example 16 Intramuscular injection 40 mq/ml.
A injectable pharmaceutical preparation can be manufactured by dissolving 40 g of 8,8'-(carbonyl-bis(imino-N-methyl-5,3 pyrrole-carbonyl-imino(N-methyl-5,3-pyrrole)carbonylimino)) bis(1 ,3,5-naphthalentrisulfonic acid)hexasodium salt in water for injection (1000 ml) and sealing ampoules of 1-10 ml.

Claims (9)

LAIMS
1. A compound of formula (I)
wherein W is =0, =S or =N-H each of m and n, being the same or different, is an integer of 1 to 4; each of B and B1, which may be the same or different, is either a group chosen from: a) a -(CH2) p-NR1R2 group, wherein p is an integer of 2 to 4 and each of R1 and R2, independently, is hydrogen or C1-C6 alkyl
group, wherein is an integer of 1 to 4; R3 is hydrogen and each of R4 and R5, independently, is hydrogen or C1-C6 alkyl; or R3 and R4, taken together, form a -CH=CH-/-CH2-CH2- or -CH2-CH2-CH2 chain, CH2 is is hydrogen or C1-C6 alkyl; c) a saturated or unsaturated, carbocyclic or condensed carbocyclic ring substituted by one to three basic graphs; d) a saturated or unsaturated, heteromonocyclic or hetero bicyclic ring, containing one to three heteroatoms chosen from nitrogen, oxygen and sulphur, substituted by one to three basic groups; or a group chosen from e) a saturated or unsaturated, carbocyclic or condensed carbocyclic ring substituted by one to three acid groups;; f) a saturated or unsaturated, heteromonocyclic or hetero bicyclic ring, containing one Lc three heteroatoms chosen from nitrogen, oxygen and sulphur, substituted by one or more acid groups; g) a pyranyl or furanyl sugar residue substituted by one to three acid groups; or h) a -CH2(CHA)@CH2A group, wherein each A group, being the same or different, is an acid group and r is 0, l or 2; and the pharmaceutically acceptable salts thereof.
2. A compound of formula (.), according to claim 1, wherein each of m and n, being the same, is 2 or 3; W is as defined in claim 1, each of B and B1 which are the same or different, is either a group chosen from a)-(CH2)p-NR1R2 wherein p is 2 or 3 and each of R1 and R2 independently is hydrogen or C1-C4 alkyl
wherein q is 2 or 3;R3, R4 and R5 are each hydrogen or R3 and R4, together, form a -CH2-CH2-, -CH=CH or -c;I , -CH2-CH2- chain and R5 is hydrogen; c') a phenyl or naphthyl group substituted by one, two or three basic groups chosen Independently from
in wliich s is 0,1,2,3, or 4 and each of R6and R7, independently, is hydrogen or C1-C4 alkyl, or d') a thiazole, pyrimidine or tetrahydropyranyl ring substituted hy one, two or three basic groups, as cefined above under c'); or a group chosen from : e') an unsaturated carbocyclic or condensed carbocyclic ring substituted by 1 to 3 acid groups; f) a tetrahydropyranyl or tetrahydrofuranyl ring substituted by l to 3 acid groups; or g' ) a glucosefuranosyl residue substituted by 1 to 3 acid groups; and the pharma ceutically acceptable salts thereof.
3. A compound selected from the group consisting of 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolearbonyl imino(N-methyl-5,3-pyrrole)carbonylimino))-bis(N-methyl -5,3-pyrrolecarbonylimio(3-propionamidine)) ; 4,4'-(1,3-guanidine-bis-(N-methyl-5,3-pyrrolecarbonyl imino(N-methyl-5;n-pyrrole)carbonylimino))-bisw -methyl- 5,3-pyrrolecarbonylimino(3-propionamidine)) ; 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino (N-methyl-5,3-pyrrole)carbonylimino))-bis(1-naphthaleneamine -N,N-dimethyl); 4,4'-(carbonyl-bis(imino-N-methyl-53-pyrrolecarbonyl imino(N-methyl-5,3-pyrrole)carbonylimino))bis(1 naphthalen sulfonic acid); 8,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonylimino(N-methyl-5,3-pyrrole)carbonylimino))bis(1-naphthalensulfonic acid);; e,8'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl- 5,3-pyrrole)carbonylimino) )bis( 1,3-naphthalendisulfonic acid); 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3'-pyrrole)carbonylimino) )bis( 1,7-naphthalendi- sulfonic acid); 4,4'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,5-naphthalendisulfonic acid): 8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)caronylimino))bis(1,3,5-naphthalentrisulfonic acid):: 8,8'-(carbonyl-bis(imino-N-methyl-5,3 -pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3,6 -naphthalentisulfonic acid); 7,7' -(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl- 5,3 pyrrole)carbonylimino))bis(1,3naphthalendi- sulfonic acid); 6,6'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3-naphthalendisulfonic acid); 3,3'-(carbonyl-bis( imino-N-methyl- 5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,7 naphthalendi sulfonic acid); 3,3'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(2,7 -naphthalendi sulfonic acid); 7,7' (carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3,5 -naphthalentri sulfonic acid);; 7,7'-thiocarbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pyrrole)carbonylimino))bis(1,3 -naphthalendi sulfonic acid); 2,2'-(carbonyl-bis(imino-N-methyl-5,3-pyrrolecarbonyl-imino (N-methyl-5,3-pirrole)carbonylimino))bis(2-deoxy-D-glucose6-sulphate); and 2,2'(carbonyl-bis(imino-N-methyl- 5,3-pyrrolecarbonyl-imino (N-methyl- 5,3 pyrrole) carbonylimino))bis(2-deoxy-D-glucose6-phosphate); and the pharmaceutically acceptable salts thereof.
4. A process for the preparation of a compound of formula (I), or a pharmaceutically acceptable salt thereof, according to clain 1, the process comprising: a) reacting a compound of formula (II)
wherein n and B are as definedir.claimlor a salt thereof, with a compound of formula (III)
wherein W' is =O or =S, and each of the X groups, which may be the same or different, is a leaving group, so as to obtain a compound of formula (I), in which W is O or =S, m and n are the same and B and B1 are the same;; or b) reacting a compound of formula (IV), or a salt thereof,
wtierel n B, X, W' and m are as defined above, with a compound of formula (II). as defined above, so as to obtain a compound of formula (I) wherein W is =O or =S; or c) reacting a compound of formula (V), or a salt thereof,
wherein Band m are as defined in claml with a compound of formula (II), as defined above. so as to obtain a compound of formula (1), wherein W is =NIl; and if desired, salifying a compound of formula (I) thus obtained; and/or if desired, obtaining a free compound of formula (I) from a salt thereof.
5. A pharmaceutical composition containing a pharmaceutically acceptable carrier and/or diluent and, as an active principle, a compound of formula (I) according to claim 1 or apharrnaceuticaL- ly acceptable salt thereof.
6 . A compound of formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, for use as an angiogenesis inhibitor.
7. Use of a compound of formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, in the preparation of a medicament for use in the treatment of ang iogenesis.
8 . Products containing a compound of formula (I), according to claim 1, or a pharmaceutically acceptable salt thereof, and an antitumor agent as a combined preparation for simultaneous, separate or sequential use in anti-cancer therapy.
9. A compound of formula: (XI):
or an acid addition salt thereof.
GB9121205A 1991-10-04 1991-10-04 Derivatives of poly-5-amino-3-carboxy-1-methyl compounds Withdrawn GB2260134A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2310207A (en) * 1996-02-15 1997-08-20 Pharmacia Spa Antiviral ureido derivatives of substituted heterocyclic compounds
WO1998003573A1 (en) * 1996-07-17 1998-01-29 Biomolecular Research Institute Ltd. Angiogenic inhibitory compounds
EP3381897A1 (en) 2017-03-27 2018-10-03 Leadiant Biosciences SA Derivatives of the disodium 2,2'-{carbonylbis[imino-3,1-phenylenecarbonylimino(1-methyl-1h-pyrrole-4,2-diyl)carbonylimino]}dinaphthalene-1,5-disulfonate salt and related compounds as heparanase inhibitors for the treatment of cancer

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1061639A (en) * 1963-07-26 1967-03-15 Farmaceutici Italia Pyrrole derivatives
GB2178036A (en) * 1985-07-16 1987-02-04 Erba Farmitalia Poly-4-aminopyrrole-2-carboxamido derivatives and process for their preparation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1061639A (en) * 1963-07-26 1967-03-15 Farmaceutici Italia Pyrrole derivatives
GB2178036A (en) * 1985-07-16 1987-02-04 Erba Farmitalia Poly-4-aminopyrrole-2-carboxamido derivatives and process for their preparation

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2310207A (en) * 1996-02-15 1997-08-20 Pharmacia Spa Antiviral ureido derivatives of substituted heterocyclic compounds
WO1998003573A1 (en) * 1996-07-17 1998-01-29 Biomolecular Research Institute Ltd. Angiogenic inhibitory compounds
US6426067B1 (en) 1996-07-17 2002-07-30 Biomolecular Research Institute, Ltd. Angiogenic inhibitory compounds
EP3381897A1 (en) 2017-03-27 2018-10-03 Leadiant Biosciences SA Derivatives of the disodium 2,2'-{carbonylbis[imino-3,1-phenylenecarbonylimino(1-methyl-1h-pyrrole-4,2-diyl)carbonylimino]}dinaphthalene-1,5-disulfonate salt and related compounds as heparanase inhibitors for the treatment of cancer
WO2018177863A1 (en) 2017-03-27 2018-10-04 Leadiant Biosciences Sa In Liquidazione Derivatives of the disodium 2,2'-{carbonylbis[imino-3,1-phenylenecarbonylimino(1-methyl-1h-pyrrole-4,2-diyl) carbonylimino]}dinaphthalene-1,5-disulfonate salt and related compounds as heparanase inhibitors for the treatment of cancer

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