Pharmaceutical compositions and articles of manufacture useful in reversal of a clinical epiosode of an incurable disease and methods of use thereof

Abstract

A method of reversing a clinical episode of a disease which is generally considered incurable in a subject. The method includes providing an immune-globulin preparation containing a detectable titre of antibodies to the disease which is generally considered incurable and administering the immune-globulin preparation to the subject. Preferably, the immune globulin preparation is a pool of immune globulin fractions gathered from blood of donors living in an area where the disease is endemic. Further disclosed are pharmaceutical compositions and articles of manufacture suited for use in practice of the method.

What is claimed is:  
     
         1 . A method of reversing a clinical episode of a disease which is generally considered incurable in a subject, the method comprising: 
 (a) providing an immune-globulin preparation containing a detectable titre of antibodies to the disease which is generally considered incurable,    (b) administering said immune-globulin preparation to the subject.    
     
     
         2 . The method of  claim 1 , wherein said immune globulin preparation is selected from the group consisting of a pool of immunoglobulins from a plurality of donors, a monoclonal antibody preparation and immuno-globulins derived from a single donor.  
     
     
         3 . The method of  claim 1 , wherein said immune-globulin preparation includes at least one immuno-globulin selected from the group consisting of IgG, IgM, IgA, and IgY.  
     
     
         4 . The method of  claim 2 , further comprising recruiting said plurality of donors from a geographic area in which the disease which is generally considered incurable is endemic.  
     
     
         5 . The method of  claim 4 , wherein said geographic area includes at least a portion of an area selected from the group consisting of the state of Israel and territories administered thereby.  
     
     
         6 . The method of  claim 1 , wherein said disease which is generally considered incurable is a viral disease selected from the group consisting of West Nile Virus, Hepatitis A, Hepatitis B, Hepatitis C, HIV, RSV, CMV, HSV, ESV, VSV, Ebola and tick borne encephalitis.  
     
     
         7 . The method of  claim 1 , wherein said administering is performed via a route of administration selected from the group consisting of intravenously, intraperitoneally, subcutaneously, intramuscularly, orally, intraocularly, intranasally, vaginally and rectally.  
     
     
         8 . A pharmaceutical composition for reversing a clinical episode of a disease which is generally considered incurable in a subject, the composition comprising, as an active ingredient, a therapeutically effective amount of an immune-globulin preparation containing a detectable titre of antibodies to the disease which is generally considered incurable and a physiologically acceptable carrier and/or excipient.  
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein said immune globulin preparation is selected from the group consisting of a pool of immuno-globulins from a plurality of donors, a monoclonal antibody preparation and immuno-globulins derived from a single donor.  
     
     
         10 . The pharmaceutical composition of  claim 8 , wherein said immune-globulin preparation includes at least one immuno-globulin selected from the group consisting of IgG, TgM, IgA, and IgY.  
     
     
         11 . The pharmaceutical composition of  claim 9 , wherein said plurality of donors are recruited from a geographic area in which the disease which is generally considered incurable is endemic.  
     
     
         12 . The pharmaceutical composition of  claim 11 , wherein said geographic area includes at least a portion of an area selected from the group consisting of the state of Israel and territories administered thereby.  
     
     
         13 . The pharmaceutical composition of  claim 8 , wherein said disease which is generally considered incurable is a viral disease selected from the group consisting of West Nile Virus, Hepatitis A, Hepatitis B, Hepatitis C, HIV, RSV, CMV, HSV, ESV, VSV, Ebola and tick borne encephalitis.  
     
     
         14 . The pharmaceutical composition of  claim 8 , wherein said administering is performed via a route of administration selected from the group consisting of intravenously, intraperitoneally, subcutaneously, intramuscularly, orally, intraocularly, intranasally, vaginally and rectally.  
     
     
         15 . An article of manufacture comprising packaging material and a pharmaceutical composition identified for reversing a clinical episode of a disease which is generally considered incurable in a subject being contained within said packaging material, said pharmaceutical composition including, as an active ingredient, a therapeutically effective amount of an immune-globulin preparation containing a detectable titre of antibodies to the disease which is generally considered incurable and a pharmaceutically acceptable carrier.  
     
     
         16 . The article of manufacture of  claim 15 , wherein said immune globulin preparation is selected from the group consisting of a pool of immuno-globulins from a plurality of donors, a monoclonal antibody preparation and immuno-globulins derived from a single donor.  
     
     
         17 . The article of manufacture of  claim 15 , wherein said immune-globulin preparation includes at least one immuno-globulin selected from the group consisting of IgG, IgM, IgA, and IgY.  
     
     
         18 . The article of manufacture of  claim 9 , further comprising recruiting said plurality of donors from a geographic area in which the disease which is generally considered incurable is endemic.  
     
     
         19 . The article of manufacture of  claim 15 , wherein said disease which is generally considered incurable is a viral disease selected from the group consisting of West Nile Virus, Hepatitis A, Hepatitis B, Hepatitis C, HIV, RSV, CMV, HSV, ESV, VSV, Ebola and tick borne encephalitis.  
     
     
         20 . The article of manufacture of  claim 15 , wherein said administering is performed via a route of administration selected from the group consisting of intravenously, intraperitoneally, subcutaneously, intramuscularly, orally, intranasally, intraocularly, vaginally and rectally.