US2004029817A1PendingUtilityA1

Derivatives of polyene macrolides and preparation and use thereof

Assignee: MICROLOGIX BIOTECH INCPriority: Jan 14, 2000Filed: Apr 25, 2003Published: Feb 12, 2004
Est. expiryJan 14, 2020(expired)· nominal 20-yr term from priority
C07H 17/08A61P 31/10
46
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Claims

Abstract

The present invention provides a new class of polyene macrolide derivatives useful for treating or preventing fungal infections. The new polyene macrolide derivatives exhibit surprisingly superior antifungal activity and water solubility compared to amphotericin B methyl ester (AME). In addition, the new polyene macrolide derivatives have improved water solubility and lower toxicity than both amphotericin B (AmB) and AME.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . An polyene macrolide of formula I:  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein: 
 R 1  is a polyene backbone;  
 CH 2 —R 2  is a carbohydrate residue, where the illustrated CH 2  comprises the anomeric carbon of a terminal carbohydrate saccharide;  
 R 3  is alkyl or arylalkyl; and  
 X is O, S or NH,  
 with the proviso that when R 1  is a polyene backbone derived from amphotericin B, X is O, and R 3  is methyl, then R 2  is other than fructosyl.  
 
     
     
         2 . The polyene macrolide of  claim 1 , wherein R 1  is a polyene backbone derived from amphotericin B aureofacin, candicidin, candidin, levorin, mycoheptin, nystatin, partricin, perimycin, pimaricin, polyfungin, rimocidin or trichomycin.  
     
     
         3 . The polyene macrolide of  claim 2 , wherein R 1  is a polyene backbone derived from amphotericin B or nystatin.  
     
     
         4 . The polyene macrolide of  claim 1 , wherein X is O.  
     
     
         5 . The polyene macrolide of  claim 1 , wherein X is NH.  
     
     
         6 . The polyene macrolide of  claim 1 , wherein CH 2 —R 2  is an Amadori rearrangement product of a reducing carbohydrate selected from Table 1.  
     
     
         7 . The polyene macrolide of  claim 1 , wherein CH 2 —R 2  is a monosaccharide.  
     
     
         8 . The polyene macrolide of  claim 7 , wherein CH 2 —R 2  is selected from the group consisting of glucopyranose, mannopyranose, galactopyranose, fructopyranose and tagatopyranose.  
     
     
         9 . The polyene macrolide of  claim 1 , wherein CH 2 —R 2  is an oligosaccharide or a polysaccharide.  
     
     
         10 . The polyene macrolide of  claim 9 , wherein CH 2 —R 2  is selected from the group consisting of 4-O-(β-D-galactopyranosyl)-D-fructopyranose, 4-O-(β-D-glucopyranosyl)-D-fructopyranose, 4-O-(β-D-galactopyranosyl)-D-fructopyranose, 1-O-(α-D-glucopyranosyl)-D-fructopyranose, sucrose, maltose, lactose, cellobiose, L-rhinnose and D-ribose.  
     
     
         11 . The polyene macrolide of  claim 1 , wherein R 3  is lower alkyl, methyl, allyl or benzyl.  
     
     
         12 . The polyene macrolide of  claim 11 , wherein R 1  is a polyene backbone derived from amphotericin B.  
     
     
         13 . The polyene macrolide of  claim 11 , wherein CH 2 —R 2  is selected from the group consisting of 4-O-(β-D-galactopyranosyl)-D-fructopyranose, 4-O-(β-D-glucopyranosyl)-D-fructopyranose, 4-O-(β-D-galactopyranosyl)-D-fructopyranose and 4-O-(α-D-glucopyranosyl)-D-fructopyranose.  
     
     
         14 . The polyene macrolide of  claim 1 , which has the formula:  
       
         
           
           
               
               
           
         
       
     
     
         15 . The polyene macrolide of  claim 1 , which has the formula:  
       
         
           
           
               
               
           
         
       
     
     
         16 . The polyene macrolide of  claim 1 , which has the formula:  
       
         
           
           
               
               
           
         
       
     
     
         17 . The polyene macrolide of  claim 1 , which has the formula:  
       
         
           
           
               
               
           
         
       
     
     
         18 . A method of making a polyene macrolide derivative according to  claim 1 , comprising reacting an ester, thioester or amide polyene macrolide derivative according to structural formula (II):  
       
         
           
           
               
               
           
         
         wherein R 1 , X and R 3  are as previously defined in  claim 1 , with a reducing carbohydrate under Amadori rearrangement conditions.  
       
     
     
         19 . The method of  claim 16 , in which the molar ratio of reducing carbohydrate to ester, thioester or amide polyene macrolide derivative is about 2:1.  
     
     
         20 . The method of  claim 16  in which the reaction is carried out under non-anhydrous conditions.  
     
     
         21 . The compound produced by the method of  claim 16 , wherein when R 1  is derived from amphotericin B, X is O and R 3  is methyl, lower alkanyl or lower alkyl, then the reducing carbohydrate is not D-mannose or α-D-glucose.  
     
     
         22 . A pharmaceutical composition comprising a polyene macrolide derivative according to  claim 1  and a pharmaceutically acceptable carrier, diluent, or excipient.  
     
     
         23 . A method for treating a fungal infection, comprising the step of administering to a host having a fungal infection a therapeutically effective amount of a polyene macrolide of formula (III):  
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
 Y is O, S or NH;  
 R 4  is a polyene backbone;  
 CH 2 —R 5  is a carbohydrate residue, where the illustrated CH 2  comprises the anomeric carbon of a terminal carbohydrate saccharide; and  
 R 6  is alkyl or arylalkyl.  
 
       
     
     
         24 . The method of  claim 23  wherein said polyene macrolide is administered by topical application.  
     
     
         25 . The method of  claim 23  wherein said polyene macrolide is the polyene macrolide according to  claim 1 .  
     
     
         26 . The method of  claim 23  wherein said polyene macrolide is the polyene macrolide according to  claim 13 .  
     
     
         27 . The method of  claim 23  wherein said polyene macrolide is the polyene macrolide according to  claim 14 .  
     
     
         28 . The method of  claim 23  wherein said polyene macrolide is the polyene macrolide according to  claim 15 .  
     
     
         29 . The method of  claim 23  wherein said polyene macrolide is the polyene macrolide according to  claim 16 .  
     
     
         30 . The method of  claim 23  wherein said polyene macrolide is the polyene macrolide according to  claim 17 .  
     
     
         31 . A method of preventing a fungal infection, comprising the step of administrating to a subject an amount of a polyene macrolide derivative effective to prevent the fungal infection, wherein the polyene macrolide derivative has the formula (III).  
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
 Y is O, S or NH;  
 R 4  is a polyene backbone;  
 CH 2 —R 5  is a carbohydrate residue, where the illustrated CH 2  comprises the anomeric carbon of a terminal carbohydrate saccharide; and  
 R 6  is alkyl or arylalkyl.

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