Anti-Cancer Combination Treatment and Kit-of-Parts

Abstract

In one aspect the present invention relates to pharmaceutical kits of parts suitable for treating neoplastic diseases such as cancer comprising an anti-cancer medicament, a Basidiomycete bioactive agent in solid or liquid form, and, optionally instructions for a dosing regime.

1 .- 195 . (canceled) 
     
     
         196 . A pharmaceutical kit of parts comprising
 a) an anti-cancer medicament;   b) immune stimulating, heteropolymeric polysaccharides isolated from a liquid growth medium of a liquid culture of  Lentinus edodes  by ultracentrifugation, and   c) instructions for a dosing regime;   wherein the heteropolymeric polysaccharides have a backbone with side chains;   wherein the heteropolymeric polysaccharides comprise glucose, galactose and mannose monosaccharide units linked by (1-3)-beta bonds or (1-6)-beta bonds;   wherein the heteropolymeric polysaccharides are obtained by cultivating  Lentinus edodes  at a temperature of from 23° C. to 32° C. in an agitated, liquid growth medium supplied with an oxygen source;   wherein heteropolymeric polysaccharides present in said liquid growth medium are not subjected to alcohol precipitation during the isolation thereof by ultracentrifugation.   
     
     
         197 . The kit according to  claim 196 , wherein said anticancer medicament is suitable for administration simultaneously with the administration of the heteropolymeric polysaccharides. 
     
     
         198 . A method of treatment of an immunocompromised individual suffering from a cancer, said method comprising the step of administering according to a set dosage regime the pharmaceutical kit of parts according to  claim 196  to said immunocompromised individual suffering from a cancer. 
     
     
         199 . The method of  claim 198 , wherein the anti-cancer medicament and the heteropolymeric polysaccharides are administered simultaneously. 
     
     
         200 . The method of  claim 198 , wherein the anti-cancer medicament and the heteropolymeric polysaccharides are administered simultaneously as a co-formulation. 
     
     
         201 . The method of  claim 198 , wherein the anti-cancer medicament and the heteropolymeric polysaccharides are administered sequentially. 
     
     
         202 . The method of  claim 198 , wherein the individual is a human being. 
     
     
         203 . A method of treatment or prevention of undesirable side-effects in an individual suffering from a cancer, wherein said undesirable side-effects are caused in whole or in part by an anti-cancer treatment comprising the step of administering an anti-cancer medicament to said individual,
 wherein the treatment or prevention of said undesirable side-effects in said individual suffering from a cancer comprises the step of co-administering to said individual a composition comprising immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes;      wherein said heteropolymeric polysaccharides have a backbone with side chains,   wherein the heteropolymeric polysaccharides comprise glucose, galactose and mannose monosaccharide units linked by (1-3)-beta bonds or (1-6)-beta bonds,   wherein the heteropolymeric polysaccharides are obtained by cultivating  Lentinus edodes  at a temperature of from 23° C. to 32° C. in an agitated, liquid growth medium supplied with an oxygen source, and   wherein said heteropolymeric polysaccharides present in said liquid growth medium are obtained by ultracentrifugation and not subjected to alcohol precipitation during the isolation thereof by ultracentrifugation.   
     
     
         204 . The method of treatment or prevention of  claim 203 , wherein said anti-cancer treatment comprises chemotherapy or radiotherapy, or a combination thereof. 
     
     
         205 . The method of treatment or prevention of  claim 203 , wherein the immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes  are administered prophylactically to said individual suffering from a cancer prior to the administration to said individual of the anti-cancer medicament as part of an anti-cancer treatment. 
     
     
         206 . The method of treatment or prevention of  claim 205 , wherein the treatment involving administration of the immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes  is initiated prior to the initiation of any anti-cancer treatment. 
     
     
         207 . The method of treatment or prevention of  claim 206 , wherein the treatment involving administration of the immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes  continues during the anti-cancer treatment. 
     
     
         208 . The method of treatment or prevention of  claim 206 , wherein the immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes  are administered at intervals during the anti-cancer treatment. 
     
     
         209 . The method of treatment or prevention of  claim 208 , wherein the immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes  are administered at intervals during periods in which the anti-cancer medicament is not being administered to the individual suffering from a cancer. 
     
     
         210 . The method of treatment or prevention of  claim 209 , wherein the administration to the individual suffering from a cancer of the immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes  at intervals between the periods of anti-cancer therapy in which the anti-cancer medicament is being administered, reduces the risk that the treated individual acquires an infection. 
     
     
         211 . The method of  claim 203 , wherein the individual is a human being. 
     
     
         212 . The method of  claim 211 , wherein the human being is an immunocompromised human being. 
     
     
         213 . A method of treating a cancer in a subject comprising co-administering a therapeutically effective amount of a monoclonal antibody and a therapeutically effective amount of a composition comprising immune stimulating, heteropolymeric polysaccharides isolated from the liquid growth medium of a liquid culture of  Lentinus edodes;    wherein said heteropolymeric polysaccharides have a backbone with side chains,   wherein the heteropolymeric polysaccharides comprise glucose, galactose and mannose monosaccharide units linked by (1-3)-beta bonds or (1-6)-beta bonds,   wherein the heteropolymeric polysaccharides are obtained by cultivating  Lentinus edodes  at a temperature of from 23° C. to 32° C. in an agitated, liquid growth medium supplied with an oxygen source, and   wherein said heteropolymeric polysaccharides present in said liquid growth medium are obtained by ultracentrifugation and not subjected to alcohol precipitation during the isolation thereof by ultracentrifugation.   
     
     
         214 . The method of  claim 212 , wherein the monoclonal antibody is an anti-CD20 monoclonal antibody, a monoclonal antibody that binds to a Her-2/neu receptor, or a monoclonal antibody that binds to a cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). 
     
     
         215 . The method of  claim 212 , wherein the subject is a human subject. 
     
     
         216 . The method of  claim 212 , wherein the human subject is an immunocompromised human subject.