US2003225037A1PendingUtilityA1

Method for the treatment or prevention of Flaviviridea viral infection using nucleoside analogues

58
Assignee: IAF BIOCHEM INTPriority: Nov 4, 1999Filed: Mar 27, 2003Published: Dec 4, 2003
Est. expiryNov 4, 2019(expired)· nominal 20-yr term from priority
Inventors:Richard Storer
A61K 38/21A61K 31/505A61K 31/52A61P 31/14A61K 31/53A61K 31/415A61K 45/06A61K 38/208
58
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Claims

Abstract

In accordance with the present invention there is provided a method for treating or preventing a Flaviviridea viral infection in a host comprising administering a therapeutically effective amount of at least one compound of formula (I) or (II) or or a pharmaceutically acceptable salts thereof, wherein Ra, R, Z and Y are defined in the application.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A method for treating or preventing a  Flaviviridae  viral infection in a host comprising administering a therapeutically effective amount of at least one compound having the formula I or a pharmaceutically acceptable salt thereof:  
       
         
           
           
               
               
           
         
       
       wherein: 
 R is H, —NR 2 R 3  or OR 4  wherein 
 R 2  is H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 3-8 cycloalkyl;  
 R 3  is H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl;  
 R 4  is H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl; and  
 
 Ra is chosen from H, monophosphate, diphosphate, triphosphate, carbonyl substituted with a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 6-10  aryl and  
                     
 wherein each Rc is independently chosen from H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl and an hydroxy protecting group;  
 wherein said nucleoside is present in the form of the (−) enantiomer, (+) enantiomer and mixtures thereof, including racemic mixtures.  
 
     
     
         2 . The method of  claim 1  wherein R is NH 2 , H or OH.  
     
     
         3 . The method of  claim 1  wherein R is NH 2  or OH.  
     
     
         4 . The method of  claim 1  wherein R is OH.  
     
     
         5 . The method of  claim 1  wherein R is —NR 2 R 3  wherein R 2  is cycloropyl and R 3  is H.  
     
     
         6 . The method of  claim 1  wherein Ra is chosen from H, monophosphate, diphosphate, and triphosphate.  
     
     
         7 . The method of  claim 1  wherein Ra is chosen from monophosphate, diphosphate, and triphosphate.  
     
     
         8 . The method of  claim 1  wherein Ra is triphosphate.  
     
     
         9 . The method of  claim 1  wherein Ra is H.  
     
     
         10 . The method as defined in  claim 1  wherein said compound of formula I of the present invention is substantially in the form of the (−) enantiomer.  
     
     
         11 . The method of  claim 1  which comprises administering at least one compound chosen from: 
 Compound 1 cis-2-hydroxymethyl-4-(2′-amino-6′-cyclopropylamino-purine-9′-yl)-1,3-dioxolane;  
 Compound 2 cis-2-hydroxymethyl-4-(2′-amino-6′-cyclobutylamino-purine-9′-yl)-1,3-dioxolane;  
 Compound 3 cis-2-hydroxymethyl-4-(2′-amino-6′-cyclopentylamino-purine-9′-yl)-1,3-dioxolane;  
 Compound 4 -cis-2-hydroxymethyl-4-(2′-6′-diamino-purin-9′-yl)-1,3-dioxolane;  
 Compound 5 cis-2-hydroxymethyl-4-(guanin-9′-yl)-1,3-dioxolane;  
 Compound 6 cis-2-hydroxymethyl-4-(adenin-9′-yl)-1,3-dioxolane;  
 Compound 7 cis-2-hydroxymethyl-4-(2′amino-6′-chloro-purin-9′-yl)-1,3-dioxolane; or  
 Compound 8 cis-2-hydroxymethyl-4-(2′amino-purin-9′-yl)-1,3-dioxolane.  
 
     
     
         12 . The method of  claim 1  which comprises administering at least one compound chosen from 
 Compound 1(−) cis-2-hydroxymethyl-4-(2′-amino-6′-cyclopropylamino-purine-9′-yl)-1,3-dioxolane;  
 Compound 2(−) cis-2-hydroxymethyl-4-(2′-amino-6′-cyclobutylamino-purine-9′-yl)-1,3-dioxolane;  
 Compound 3(−) cis-2-hydroxymethyl-4-(2′-amino-6′-cyclopentylamino-purine-9′-yl)-1,3-dioxolane;  
 Compound 4(−) -cis-2-hydroxymethyl-4-(2′-6′-diamino-purin-9′-yl)-1,3-dioxolane;  
 Compound 5(−) cis-2-hydroxymethyl-4-(guanin-9′-yl)-1,3-dioxolane;  
 Compound 6) (−) cis-2-hydroxymethyl-4-(adenin-9′-yl)-1,3-dioxolane;  
 Compound 7(−) cis-2-hydroxymethyl-4-(2′amino-6′-chloro-purin-9′-yl)-1,3-dioxolane; or  
 Compound 8(−) cis-2-hydroxymethyl-4-(2′amino-purin-9′-yl)-1,3-dioxolane.  
 
     
     
         13 . The method as defined in  claim 1  wherein said  Flaviviridae  viral infection is hepatitis C (HCV).  
     
     
         14 . The method as defined in  claim 10  wherein said  Flaviviridae  viral infection is hepatitis C (HCV).  
     
     
         15 . The method as defined in  claim 11  wherein said  Flaviviridae  viral infection is hepatitis C (HCV).  
     
     
         16 . The method as defined in  claim 12  wherein said  Flaviviridae  viral infection is hepatitis C (HCV).  
     
     
         17 . A method for treating or preventing a hepatitis C viral infection in a host comprising administering to the host a therapeutically effective amount of at least one compound according to formula I as defined in  claim 1  and at least one further antiviral agent.  
     
     
         18 . The method according to  claim 17  wherein the antiviral agent is chosen from viral serine protease inhibitor, viral polymerase inhibitor and viral helicase inhibitor.  
     
     
         19 . The method according to  claim 17  wherein the antiviral agent chosen from interferon (IFN), interferon α-2a, interferon α-2b, consensus interferon (CIFN), ribavirin, amantadine, rimantadine, interleukine-12, ursodeoxycholic acid (UDCA), glycyrrhizin and silybum marianum.  
     
     
         20 . The method according to  claim 17  wherein the antiviral agent chosen from interferon α and ribavirin.  
     
     
         21 . A pharmaceutical composition for treating or preventing a hepatitis viral C infection comprising administering at least one compound according to formula I as defined in  claim 1  together with at least one pharmaceutically acceptable carrier or excipient.  
     
     
         22 . A method for inhibiting or reducing the activity of viral polymerase in a host comprising administering a therapeutically effective amount of at least one compound having the formula I:  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salts thereof, wherein: 
 R is H, —NR 2 R 3  or OR 4  wherein  
 R 2  is H, C 1-6  alkyl, C 2-6  alkenyl,or C 2-6  alkynyl;  
 R 3  is H or a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl;  
 R 4  is H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl; and  
 Ra is chosen from H, monophosphate, diphosphate, triphosphate, carbonyl substituted with a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 6-10  aryl and  
                     
 wherein each Rc is independently chosen from H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl and an hydroxy protecting group;  
 wherein said nucleoside is present in the form of the (−) enantiomer,(+) enantiomer and mixtures thereof, including racemic mixtures.  
 
     
     
         23 . The method of  claim 22  wherein said viral polymerase is a HCV polymerase.  
     
     
         24 . A method for treating or preventing a  Flaviviridea  viral infection in a host comprising administering a therapeutically effective amount of at least one compound having the formula II or a pharmaceutically acceptable salt thereof:  
       
         
           
           
               
               
           
         
         wherein  
         Z is H, —NR′ 2 R 3′  or OR 4′  wherein  
         R 2′  is H, C 1-6  alkyl, C 2-6  alkenyl,or C 2-6  alkynyl;  
         R 3′  is H or a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl;  
         R 4′ is H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl; and  
         Y is N or C—X;  
         X is chosen from of H, halogen, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, CN, CF 3 , N 3 , NO 2 , C 6-10  aryl, C 6-10  heteroaryl and CORb wherein Rb is chosen from of H, OH, SH, C 1-6  alkyl, C 1-6  aminoalkyl, C 1-6  alkoxy and C 1-6  thioalkyl;  
         and Ra is chosen from of H, monophosphate, diphosphate, triphosphate, carbonyl substituted with a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 6-10  aryl, and  
         
           
             
             
                 
                 
             
           
         
         wherein each Rc are independently chosen from H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl and an hydroxy protecting group, wherein said compound is in the form of a single enantiomer or a mixture thereof including racemic mixtures.  
       
     
     
         25 . The method of  claim 24  wherein said compound of formula II of the present invention is substantially in the form of the (+) enantiomer.  
     
     
         26 . The method of  claim 24  wherein sais-compound of formula II of the present invention is substantially in the form of the (−) enatiomer.  
     
     
         27 . The method of  claim 24  wherein Ra is chosen from H, monophosphate, diphosphate, and triphosphate.  
     
     
         28 . The method of  claim 24  wherein Ra is chosen from monophosphate, diphosphate, and triphosphate.  
     
     
         29 . The method of  claim 24  wherein Ra is triphosphate.  
     
     
         30 . The method of  claim 24  wherein Ra is H.  
     
     
         31 . The method of  claim 24  wherein Y is C—X.  
     
     
         32 . The method of  claim 24  wherein Y is C—X and X is H, methyl, or Halogen.  
     
     
         33 . The method of  claim 24  wherein Y is C—X and X is H, methyl or halogen.  
     
     
         34 . The method of  claim 24  wherein Y is C—X and X is H, methyl or F.  
     
     
         35 . The method of  claim 24  wherein Y is C—X and X is H or F.  
     
     
         36 . The method of  claim 24  wherein Y is C—X and X is H.  
     
     
         37 . The method of  claim 24  wherein Y is C—X and X is F.  
     
     
         38 . The method of  claim 24  wherein Z is OH.  
     
     
         39 . The method of  claim 24  wherein Z is NH 2 .  
     
     
         40 . The method of  claim 25  wherein Ra is chosen from H, monophosphate, diphosphate, and triphosphate.  
     
     
         41 . The method of  claim 25  wherein Ra is chosen from monophosphate, diphosphate, and triphosphate.  
     
     
         42 . The method of  claim 25  wherein Ra is triphosphate.  
     
     
         43 . The method of  claim 25  wherein Ra is H.  
     
     
         44 . The method of  claim 25  wherein Y is C—X.  
     
     
         45 . The method of  claim 25  wherein Y is C—X and X is H, methyl, or Halogen.  
     
     
         46 . The method of  claim 25  wherein Y is C—X and X is H, methyl or halogen.  
     
     
         47 . The method of  claim 25  wherein Y is C—X and X is H, methyl or F.  
     
     
         48 . The method of  claim 25  wherein Y is C—X and X is H or F.  
     
     
         49 . The method of  claim 25  wherein Y is C—X and X is H.  
     
     
         50 . The method of  claim 25  wherein Y is C—X and X is F.  
     
     
         51 . The method of  claim 25  wherein Z is OH.  
     
     
         52 . The method of  claim 25  wherein Z is NH 2 .  
     
     
         53 . The method of  claim 26  wherein Ra is chosen from H, monophosphate, diphosphate, and triphosphate.  
     
     
         54 . The method of  claim 26  wherein Ra is chosen from monophosphate, diphosphate, and triphosphate.  
     
     
         55 . The method of  claim 26  wherein Ra is triphosphate.  
     
     
         56 . The method of  claim 26  wherein Ra is H.  
     
     
         57 . The method of  claim 26  wherein Y is C—X.  
     
     
         58 . The method of  claim 26  wherein Y is C—X and X is H, methyl, or Halogen.  
     
     
         59 . The method of  claim 26  wherein Y is C—X and X is H, methyl or halogen.  
     
     
         60 . The method of  claim 26  wherein Y is C—X and X is H, methyl or F.  
     
     
         61 . The method of  claim 26  wherein Y is C—X and X is H or F.  
     
     
         62 . The method of  claim 26  wherein Y is C—X and X is H.  
     
     
         63 . The method of  claim 26  wherein Y is C—X and X is F.  
     
     
         64 . The-method of  claim 26  wherein Z is OH.  
     
     
         65 . The method of  claim 26  wherein Z is NH 2 .  
     
     
         66 . The method of  claim 24  wherein the compound of formula II is (+)Cis-2-hydroxymethyl-4-(cytosin-1′-yl)-1,3-Dioxolane (Compound #17 (+)).  
     
     
         67 . The method of  claim 24  wherein the compound of formula II is (+)Cis-2-hydroxymethyl-4-(5′-fluorocytosin-1′-yl)-1,3-Dioxolane (Compound #18 (+)).  
     
     
         68 . The method of  claim 24  wherein the compound of formula II is (−)Cis-2-hydroxymethyl-4-(5′-fluorocytosin-1′-yl)-1,3-Dioxolane (Compound #18 (−)).  
     
     
         69 . The method of  claim 24  wherein the compound of formula II is (+)Cis-2-hydroxymethyl-4-(5′-azacytosin-1′-yl)-1,3-Dioxolane (Compound #19 (+)).  
     
     
         70 . The method of  claim 24  wherein the compound of formula II is (+)-cis-2-hydroxymethyl-4-(5′-methylcytosin-1′-yl)-1,3-dioxolane(β-D-) (compound#20) (+)  
     
     
         71 . The method of  claim 24  wherein the compound of formula II is (+)-cis-2-hydroxymethyl-4-(N-1′-thiminyl)-1,3-dioxolane (-D-) (compound#21) (+)  
     
     
         72 . The method of  claim 24  wherein said  Flaviviridea  viral infection is hepatitis C.  
     
     
         73 . A method for treating or preventing a hepatitis C viral infection in a host comprising administering to the host a therapeutically effective amount of at least one compound according to formula II as defined in  claim 24  and at least one further antiviral agent.  
     
     
         74 . The method according to  claim 73  wherein the further antiviral agent is chosen from of viral serine protease inhibitor, viral polymerase inhibitor and viral helicase inhibitor.  
     
     
         75 . The method according to  claim 73  wherein the antiviral agent is chosen from interferon (IFN), interferon αx-2a, interferon α-2b, consensus interferon (CIFN), ribavirin, amantadine, rimantadine, interleukine-12, ursodeoxycholic acid (UDCA), glycyrrhizin and silybum marianum.  
     
     
         76 . The method according to  claim 73  wherein the antiviral agent chosen from interferon α and ribavirin.  
     
     
         77 . A pharmaceutical composition for treating or preventing a hepatitis viral C infection comprising administering at least one compound according to formula II as defined in  claim 73  together with at least one pharmaceutically acceptable carrier or excipient.  
     
     
         78 . A method for inhibiting or reducing the activity of viral polymerase in a host comprising administering a therapeutically effective amount of at least one compound having the formula II or a pharmaceutically acceptable salt thereof:  
       
         
           
           
               
               
           
         
         wherein  
         Z is H, —NR 2′ R 3′  or OR 4′  wherein  
         R 2′  is H, C 1-6  alkyl, C 2-6  alkenyl, or C 2-6  alkynyl;  
         R 3′  is H or a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl;  
         R 4′ is H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl; and  
         Y is N or C—X;  
         X is chosen from of H, halogen, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, CN, CF 3 , N 3 , NO 2 , C 6-10  aryl, C 6-10  heteroaryl and CORb wherein Rb is chosen from of H, OH, SH, C 1-6  alkyl, C 1-6  aminoalkyl, C 1-6  alkoxy and C 1-6  thioalkyl;  
         and Ra is chosen from of H, monophosphate, diphosphate, triphosphate, carbonyl substituted with a C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 6-10  aryl, and  
         
           
             
             
                 
                 
             
           
         
         wherein each Rc are independently chosen from H, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl and an hydroxy protecting group, wherein said compound is in the form of a single enantiomer or a mixture thereof including racemic mixtures.  
       
     
     
         79 . The method of  claim 78  wherein said viral polymerase is a HCV polymerase.

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