Preparation of biologically active complexes

Abstract

The invention provides a method for preparing a biologically active complex, said method comprising dissolving a mixture of a polypeptide element, such as alphalactalbumin or fragments thereof, in powder form and oleic acid or a pharmaceutically acceptable salt thereof also in solid form, in an aqueous solvent comprising a mixture of at least two and preferably three salts, wherein the method is carried out at moderate temperatures. The preparation does not require extensive heating and so is simple and efficient to carry out.

1 . A method for preparing a biologically active complex, said method comprising dissolving a mixture of a polypeptide element in powder form and oleic acid or a pharmaceutically acceptable salt thereof also in solid form, in an aqueous solvent comprising at least two salts, the first of which is sodium or potassium chloride and the second of which is disodium phosphate or mono-potassium phosphate, wherein the process is carried out at moderate temperature of up to 50° C. 
     
     
         2 . A method according to  claim 1  wherein the aqueous solvent further comprises a third salt which is mono-sodium or mono-potassium phosphate. 
     
     
         3 . (canceled) 
     
     
         4 . A method according to  claim 1  which is carried out at ambient temperature. 
     
     
         5 . A method according to  claim 1  which further comprises filtering a solution formed. 
     
     
         6 . A method according to  claim 1  which further comprises removing the aqueous solvent and obtaining the biologically active complex in solid form. 
     
     
         7 . A method according to  claim 6  wherein the aqueous solvent is removed by lyophilisation. 
     
     
         8 . A method according to  claim 1  wherein the polypeptide element is a naturally-occurring protein selected from alpha-lactalbumin, lysozyme or other proteins having a membrane perturbing activity, or variants thereof which lack intra-molecular bonds, or in particular, fragments of any of these proteins. 
     
     
         9 . A method according to  claim 8  wherein the polypeptide element is a peptide fragment of up to 50 amino acids. 
     
     
         10 . (canceled) 
     
     
         11 . A method according to  claim 9  wherein the peptide fragment is of SEQ ID NO 1, SEQ ID NO 2, SEQ ID NO 5, SEQ ID NO 6, or SEQ ID NO 7. 
     
     
         12 . (canceled) 
     
     
         13 . A method according to  claim 8  wherein the polypeptide is an alpha-lactalbumin. 
     
     
         14 . A method according to  claim 13  wherein the polypeptide is bovine alpha-lactalbumin. 
     
     
         15 . A method according to  claim 1  wherein the first salt is sodium chloride and the second salt is disodium monophosphate. 
     
     
         16 . (canceled) 
     
     
         17 . A method according to  claim 2  wherein the third salt is mono-potassium phosphate. 
     
     
         18 . (canceled) 
     
     
         19 . A biologically active complex obtainable by a method according to  claim 1 . 
     
     
         20 . A pharmaceutical composition comprising the biologically active complex according to  claim 19 . 
     
     
         21 . (canceled) 
     
     
         22 . A method for treating or preventing cancer or a viral infection, said method comprising administering to a patient in need thereof, an effective amount of the composition according to  claim 20 . 
     
     
         23 . A biologically active complex comprising a peptide of SEQ ID NO 6 and oleic acid or a salt thereof. 
     
     
         24 . A biologically active complex according to  claim 23  wherein the peptide is of SEQ ID NO 7. 
     
     
         25 . A peptide of SEQ ID NO 6. 
     
     
         26 . A peptide according to  claim 25  which is of SEQ ID NO 7.