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 determining the dynamics of immune system cycling in a patient having a cancer, comprising:
 a. assaying multiple samples from the patient for the level of one or more immune system marker(s) in each of the samples; and   b. analyzing the results from step (a) to determine the length of the cycle of the one or more immune system marker(s) and the levels of the one or more immune system marker(s) during the cycle.   
     
     
         46 . The method of  claim 45 , further comprising predicting subsequent cycling of the one or more immune system marker(s) based on the analysis of step (b). 
     
     
         47 . The method of  claim 46 , comprising determining or predicting a peak in the cycling of the one or more immune system marker(s). 
     
     
         48 . The method of  claim 45 , wherein the sample is selected from the group consisting of blood, serum, plasma, saliva, sputum, ocular lens fluid, sweat, faeces, urine, mucous, transdermal exudates, and pharyngeal exudates. 
     
     
         49 . The method of  claim 45 , wherein the sample is blood or a fraction thereof. 
     
     
         50 . The method of  claim 45 , wherein the step of assaying comprises assaying at least one sample every three days. 
     
     
         51 . The method of  claim 45 , wherein the step of assaying comprises assaying at least one sample every two days. 
     
     
         52 . The method of  claim 45 , wherein the step of assaying comprises assaying at least one sample every day. 
     
     
         53 . The method of  claim 45 , wherein the step of assaying comprises assaying at least one sample every twelve hours. 
     
     
         54 . The method of  claim 45 , wherein the immune system marker is an acute phase inflammatory marker. 
     
     
         55 . The method of  claim 54 , wherein the acute phase inflammatory marker is selected from the group consisting of c-reactive protein (CRP), serum amyloid A (SAA), serum amyloid P component, complement proteins C2, C3, C4, C5, C9, B, C1 inhibitor, C4 binding protein, fibrinogen, von Willebrand factor, α1-antitrypsin, α1-antichymotrypsin, α2-antiplasmin, heparin cofactor II, plasminogen activator inhibitor I, haptoglobin, haemopexin, ceruloplasmin, manganese superoxide dismutase, α1-acid glycoprotein, haeme oxygenase, mannose-binding protein, leukocyte protein I, lipoporotein (a), lipopolysaccharide-binding protein, interleukins IL-1, IL-2, IL-6, IL-10 and receptors thereof. 
     
     
         56 . The method of  claim 54 , wherein the acute phase inflammatory marker is selected from the group consisting of albumin, pre-albumin, transferrin, apoAI, apoAII, α2 HS glycoprotein, inter-α-trypsin inhibitor and histidine-rich glycoprotein. 
     
     
         57 . The method of  claim 54 , wherein the acute phase inflammatory marker is selected from the group consisting of c-reactive protein (CRP), serum amyloid A (SAA), complement protein C4, complement protein C3, and Interleukin-2. 
     
     
         58 . The method of  claim 45 , wherein the cancer is selected from the group consisting of ovarian cancer, melanoma, urothelial cancer, breast cancer prostate cancer, colorectal cancer, lung cancer, mesothelioma, glioblastoma and myeloma.