Therapeutic agents

Abstract

A method for treating an rheumatoid arthritis in a mammalian subject in need of same wherein the method comprises: administering to the mammalian subject an agent capable of modulating a ganglioside GM-1 associated activity in an amount effective to treat the disease.

1 . A method for treating rheumatoid arthritis in a mammalian subject in need of the same wherein the method comprises:
 administering to the mammalian subject an agent capable of modulating a ganglioside GM-1 (GM-1) associated activity in an amount effective to treat the disease; wherein the agent, when in vivo, has an effect on GM-1 mediated intracellular signaling events; and wherein if the agent is for co-administration with an antigen, then the agent and the antigen are not so linked to form a single active agent.   
   
   
       2 . The method according to  claim 1  wherein the effect on GM-1 mediated intracellular signaling events is due to an agent having GM-1 binding activity. 
   
   
       3 . The method according to  claim 1  wherein the agent is an immunomodulator. 
   
   
       4 . The method according to  claim 3  wherein the agent is selected from the group consisting of Ctx, Etx, the B subunit of Ctx and the B subunit of Etx and mutants and derivatives thereof. 
   
   
       5 . The method according  claim 1  wherein the agent is for co-administration with an antigen selected from the group consisting of self or cross-reacting antigen, alloantigen and xenoantigen. 
   
   
       6 . The method according to  claim 1  wherein the agent is for co-administration with an autoantigen. 
   
   
       7 . The method according to  claim 1  wherein the agent, when in vivo, is capable of modulating lymphocyte populations. 
   
   
       8 . Use of an agent in the preparation of a medicament to prevent and/or treat a rheumatoid arthritis condition; wherein the agent is capable of modulating a ganglioside GM-1 (GM-1) associated activity as determined by a reduction in the production of Th1 associated cytokines; wherein if the agent is for co-administration with an antigen, then the agent and the antigen are not so linked to form a single active agent; and wherein the modulation of the ganglioside associated activity affects the rheumatoid arthritis condition. 
   
   
       9 . The use according to  claim 8  wherein the Th1 associated cytokine is IFNγ. 
   
   
       10 . The use according to  claim 8  wherein the agent increases the production of Th2 associated cytokines. 
   
   
       11 . The use according to  claim 10  wherein the Th2 associated cytokine is selected from the group consisting of IL-4 and IL-10 cytokines. 
   
   
       12 . The use according to  claim 10  wherein the agent is capable of preventing the onset of rheumatoid arthritis. 
   
   
       13 . The use according to  claim 10  wherein the agent is co-administered with GAD, GAD65, IAA or insulin. 
   
   
       14 . The use according to  claim 13  wherein the agent is EtxB. 
   
   
       15 . A method for treating rheumatoid arthritis in a mammalian subject in need of same wherein the method comprises: co-administering EtxB having ganglioside GM-1 (GM-1) binding activity, in an amount effective to treat the disease, and an antigen selected from the group of GAD, GAD65, IAA and insulin, to the mammalian subject in an amount effective to treat the disease; said antigen and said EtxB being not so linked to form a single active agent. 
   
   
       16 . The method in accordance with  claim 1  wherein said step of administering to the mammalian subject is selected from the group consisting of: oral administration, parenteral administration and intranasal administration. 
   
   
       17 . The method in accordance with  claim 15  wherein said step of administering to the mammalian subject is selected from the group consisting of: oral administration, parenteral administration and intranasal administration.