US2012064079A1PendingUtilityA1

Compositions and Methods for Preventing Erythropoietin-Associated Hypertension

57
Assignee: LEE JONG YPriority: May 17, 2004Filed: Mar 10, 2011Published: Mar 15, 2012
Est. expiryMay 17, 2024(expired)· nominal 20-yr term from priority
Inventors:Jong Young LeeMary S. LeeJohn Lee
A61K 38/179A61K 2300/00A61K 39/39533C07K 2317/55A61K 2121/00A61K 38/1816A61P 9/12A61K 39/3955A61P 7/06C07K 16/2863A61K 2039/505
57
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Claims

Abstract

The inventors have discovered that both soluble erythropoietin-binding protein and antibodies against the erythropoietin-binding protein, when they are administered to a mammal along with erythropoietin (Epo), prevent or reduce the blood pressure increase normally caused by erythropoietin, while not affecting the hematocrit increase that is the purpose of Epo treatment. The invention provides a method of treating anemia in a mammal involving: administering erythropoietin (Epo) to the mammal; and administering to the mammal an agent selected from a soluble Epo-binding protein (Epo-bp), a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor, and a combination thereof. The invention also provides a method of reducing hypertension in a mammal receiving Epo, and pharmaceutical compositions containing a soluble Epo-bp and/or a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating anemia in a mammal comprising:
 administering erythropoietin (Epo) to the mammal; and   administering to the mammal an agent selected from a soluble Epo-binding protein (Epo-bp), a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor, and a combination thereof.   
     
     
         2 . The method of  claim 1  wherein the agent is a soluble Epo-bp. 
     
     
         3 . The method of  claim 2  wherein the soluble Epo-bp comprises a fragment of a soluble portion of a mammalian Epo receptor. 
     
     
         4 . The method of  claim 3  wherein the soluble Epo-bp comprises a fragment of at least 30 residues of SEQ ID NO:2. 
     
     
         5 . The method of  claim 4  wherein the soluble Epo-bp is a fragment of at least 30 residues of SEQ ID NO:2. 
     
     
         6 . The method of  claim 2  wherein the soluble Epo-bp comprises SEQ ID NO:2. 
     
     
         7 . The method of  claim 6  wherein the soluble Epo-bp is SEQ ID NO:2. 
     
     
         8 . The method of  claim 1  wherein the agent is a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor. 
     
     
         9 . The method of  claim 8  wherein the recognition protein binds SEQ ID NO:2. 
     
     
         10 . The method of  claim 8  wherein the recognition protein is an antibody. 
     
     
         11 . The method of  claim 10  wherein the antibody is an antibody fragment. 
     
     
         12 . The method of  claim 11  wherein the antibody fragment is Fab. 
     
     
         13 . The method of  claim 1  wherein Epo and the agent are administered together. 
     
     
         14 . The method of  claim 1  wherein Epo and the agent are administered separately. 
     
     
         15 . The method of  claim 1  wherein the amount of agent administered is at least equimolar with the amount of Epo administered. 
     
     
         16 . The method of  claim 1  wherein the amount of agent administered is about equimolar with the amount of Epo administered. 
     
     
         17 . The method of  claim 1  wherein the agent reduces an erythropoietin-induced blood pressure rise in the mammal. 
     
     
         18 . A method of reducing hypertension in a mammal receiving erythropoietin (Epo), the method comprising:
 administering to the mammal an effective amount of an agent selected from a soluble erythropoietin-binding protein (Epo-bp), a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor, and a combination thereof.   
     
     
         19 . Use of a recognition protein that binds erythropoietin (Epo) receptor on an extracellular soluble portion of the Epo receptor in medical therapy. 
     
     
         20 . The use of  claim 19  wherein the recognition protein is an antibody against SEQ ID NO:2. 
     
     
         21 . Use of a recognition protein that binds erythropoietin (Epo) receptor on an extracellular soluble portion of the Epo receptor to prepare a medicament effective to reduce erythropoietin-induced hypertension. 
     
     
         22 . The use of  claim 21  wherein the recognition protein is an antibody against SEQ ID NO:2. 
     
     
         23 . Use of a soluble erthropoietin-binding protein (Epo-bp) in medical therapy. 
     
     
         24 . The use of  claim 23  wherein the Epo-bp is SEQ ID NO:2. 
     
     
         25 . Use of a soluble erythropoietin-binding protein (Epo-bp) to prepare a medicament effective to reduce erythropoietin-induced hypertension. 
     
     
         26 . The use of  claim 25  wherein the Epo-bp is SEQ ID NO:2. 
     
     
         27 . A pharmaceutical composition comprising:
 erythropoietin (Epo); and   an agent selected from a soluble Epo-binding protein (Epo-bp), a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor, and a combination thereof.   
     
     
         28 . The pharmaceutical composition of  claim 27  wherein the recognition protein is an antibody against SEQ ID NO:2. 
     
     
         29 . The pharmaceutical composition of  claim 27  wherein the Epo-bp is SEQ ID NO:2. 
     
     
         30 . A pharmaceutical composition comprising:
 a recognition protein that binds erythropoietin (Epo) receptor on an extracellular soluble portion of the Epo receptor.   
     
     
         31 . The pharmaceutical composition of  claim 30  wherein the recognition protein is an antibody against SEQ ID NO:2. 
     
     
         32 . A pharmaceutical composition comprising:
 a soluble erythropoietin-binding protein (Epo-bp).   
     
     
         33 . The pharmaceutical composition of  claim 32  wherein the Epo-bp is SEQ ID NO:2. 
     
     
         34 . The pharmaceutical composition of  claim 32  wherein the Epo-bp is a product of a process comprising:
 expressing a fusion protein consisting of:
 (a) a first polypeptide segment having an amino terminus and a carboxyl terminus, said segment having SEQ ID NO:7 at its carboxyl terminus; and 
 (b) a second polypeptide segment consisting of SEQ ID NO:2, the second polypeptide segment covalently coupled to the carboxyl terminus of the first polypeptide segment; and 
 
 cleaving the fusion protein with thrombin.

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