Method of therapy

Abstract

Numerous diseases have been linked to the production of regulator cells. The present invention relates to the observation that the immune system is cycling in these diseases. Based on these observations, the present invention provides methods for treating diseases such as cancer and a HIV infection. The present invention also relates to methods of determining when a therapy to treat a disease characterized by the production of regulator cells should be administered to a patient.

1 - 44 . (canceled) 
     
     
         45 . A method of treating a disease characterized by the production of regulator T cells, wherein a patient suffering from the disease has been analyzed for immune system cycling by monitoring the patient for a regular oscillation of at least one of:
 a) number and/or activity of regulator T cells,   b) number and/or activity of effector T cells,   c) a marker molecule associated with the disease, and/or   d) an immune system marker, and   comprising administering an agent to treat the disease at a time selected such that the agent exerts a proportionally greater effect against the regulator T cells than the effector T cells,   wherein the agent inhibits the production of, limits the function of, and/or destroys, regulator T cells, and   wherein the agent is selected from the group consisting of anti-proliferative drugs, radiation, dsRNA and antibodies which inhibit the production and/or activity of regulator T cells, and   wherein the disease is cancer or an infection.   
     
     
         46 . The method of  claim 45 , wherein the infection is a chronic persistent infection characterized by the patient's immune system not being able to eliminate the infection. 
     
     
         47 . The method of  claim 46 , wherein the patient is infected with HIV or Hepatitis C virus. 
     
     
         48 . The method of  claim 45 , wherein the immune system marker reflects the number and/or activity of regulator T cells, and/or the number and/or activity of effector T cells. 
     
     
         49 . The method of  claim 45 , wherein the immune system marker is an acute phase inflammatory marker. 
     
     
         50 . The method of  claim 49 , wherein the acute phase inflammatory marker is selected from the group consisting of serum amyloid A, serum amyloid P and c-reactive protein. 
     
     
         51 . The method of  claim 45 , wherein the regulator T cells are CD4+CD8− T cells. 
     
     
         52 . The method of  claim 45 , wherein the agent is administered about when CD4+CD8− T cells are detected. 
     
     
         53 . The method of  claim 45 , wherein the effector T cells are CD8+CD4− T cells. 
     
     
         54 . The method of  claim 45 , wherein the agent is administered approximately when CD8+CD4− T cell numbers have peaked. 
     
     
         55 . The method of  claim 45 , wherein the marker molecule associated with the cancer is an antigen produced by a cancer cell. 
     
     
         56 . The method of  claim 45 , wherein the marker molecule associated with the infection is an antigen produced by an infectious agent. 
     
     
         57 . The method of  claim 45 , wherein the agent is administered approximately when levels of the marker molecule associated with the cancer or infection begin to decrease. 
     
     
         58 . The method of  claim 45 , wherein the patient is monitored for an acute phase inflammatory marker, and a marker molecule associated with the cancer or infection. 
     
     
         59 . The method of  claim 45 , wherein the patient is monitored for a period of at least 21 days. 
     
     
         60 . The method of  claim 45 , the patient is monitored at least about every 3 days. 
     
     
         61 . The method of  claim 45 , wherein the anti-proliferative drug is selected from the group consisting of taxol, vincristine, vinblastine and anhydro vinblastine. 
     
     
         62 . The method of  claim 45 , wherein the antibody is selected from the group consisting of: anti-CD4+, anti-CTLA-4 (cytotoxic lymphocyteassociated antigen-4), anti-GITR (glucocorticoid-induced tumour necrosis factor receptor), anti-CD28 and anti-CD25. 
     
     
         63 . The method of  claim 45 , wherein the patient has not been exposed to a treatment for the cancer or infection for at least 21 days. 
     
     
         64 . The method of  claim 45 , wherein the patient is a human. 
     
     
         65 . A method of treating a disease characterized by the production of regulator T cells, wherein a patient suffering from the disease has been analyzed for immune system cycling by monitoring the patient for a regular oscillation of at least one of:
 a) number and/or activity of regulator T cells,   b) number and/or activity of effector T cells,   c) a marker molecule associated with the disease, and/or   d) an immune system marker, and   comprising administering a vaccine to treat the disease at a time selected such that the vaccine boosts the innate immune response, producing increased numbers and/or activity of effector T cells, before the emergence of regulator T cells, and   wherein the disease is cancer or an infection.   
     
     
         66 . The method of  claim 65 , wherein the vaccine is administered about when the levels of effector T cells are increasing. 
     
     
         67 . The method of  claim 65 , wherein the vaccine is administered about when the levels of a marker molecule associated with the disease begin to decrease.