US2022313785A1PendingUtilityA1

Methods for the treatment of inflammatory joint disease

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Assignee: XALUD THERAPEUTICS INCPriority: Jul 18, 2013Filed: Jun 21, 2022Published: Oct 6, 2022
Est. expiryJul 18, 2033(~7 yrs left)· nominal 20-yr term from priority
Inventors:Raymond A. ChavezLinda May Rothblum WatkinsRobert Landry
A61K 48/005A61K 48/0091C07K 14/5428A61P 37/02A61K 48/0075A61K 38/2066A61P 29/00A61P 19/06A61P 19/02
67
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Claims

Abstract

This invention provides compositions and methods for preventing inflammatory diseases of the joints, including rheumatoid and osteoarthritis, tendonitis, bursitis, inflammation of the ligament, synovitis, gout, and systemic lupus erythematosus, wherein the methods include injecting into the inflamed joint a therapeutic anti-inflammatory composition comprising a bacterial or viral IL-10 expression construct, wherein the IL-10 expression construct comprises a bacterial or viral backbone and a nucleic acid sequence encoding interleukin-10.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A method for treating inflammatory joint disease in a subject, said method comprising injecting into the inflamed joint a therapeutic anti-inflammatory composition comprising a therapeutically effective amount of a bacterial or viral IL-10 expression construct, wherein the IL-10 expression construct comprises a bacterial or viral backbone and a nucleic acid sequence encoding interleukin-10. 
     
     
         2 . The method of  claim 1 , wherein the IL-10 expression construct is administered with an adjuvant. 
     
     
         3 . The method of  claim 2 , wherein the adjuvant is selected from D-mannose, sucrose, glucose, calcium phosphate, dendrimers, oligonucleotides, high molecular weight hyaluronic acid, or liposomes. 
     
     
         4 . The method of  claim 1 , wherein the nucleic acid sequence encoding interleukin-10 has an amino acid substitution for wildtype phenylalanine at amino acid position 129. 
     
     
         5 . The method of  claim 4 , wherein the amino acid substitution is selected from the group of serine, alanine, threonine or cysteine. 
     
     
         6 . The method of  claim 5 , wherein the nucleic acid sequence encoding interleukin-10 encodes IL-10 F129S . 
     
     
         7 . The method of  claim 1 , wherein the plasmid DNA comprises at least one nuclear targeting sequence 5′ to the IL-10 coding sequence. 
     
     
         8 . The method of  claim 1 , wherein the plasmid DNA comprises at least one nuclear targeting sequence 3′ to the IL-10 coding sequence. 
     
     
         9 . The method of  claim 1 , further comprising a diluent. 
     
     
         10 . The method of  claim 1 , wherein the joint is a knee, elbow, wrist, ankle, hip, shoulder, or spine. 
     
     
         11 . The method of  claim 1 , wherein the inflammatory joint disease is arthritis, tendonitis, bursitis, inflammation of the ligament, synovitis, gout, and systemic lupus erythematosus. 
     
     
         12 . A method for treating inflammatory joint disease in a subject, said method comprising injecting into the inflamed joint a therapeutic anti-inflammatory composition comprising a therapeutically effective amount of a bacterial or viral IL-10 expression construct, wherein the IL-10 expression construct comprises a bacterial or viral backbone and a nucleic acid sequence encoding interleukin-10; and microparticles encapsulating the expression construct. 
     
     
         13 . The method of  claim 12 , wherein the nucleic acid sequence encoding interleukin-10 has an amino acid substitution for wildtype phenylalanine at amino acid position 129. 
     
     
         14 . The method of  claim 13 , wherein the amino acid substitution is selected from the group of serine, alanine, threonine or cysteine. 
     
     
         15 . The method of  claim 14 , wherein the nucleic acid sequence encoding interleukin-10 encodes IL-10 F129S . 
     
     
         16 . The method of  claim 10 , wherein the polymer comprises poly(lactic-co-glycolic acid). 
     
     
         17 . The method of  claim 16 , wherein the polymer comprises 50:50 poly(lactic-co-glycolic acid). 
     
     
         18 . The method of  claim 10 , wherein the plasmid DNA comprises at least one nuclear targeting sequence 5′ to the IL-10 coding sequence. 
     
     
         17 . The method of  claim 10 , further comprising a diluent. 
     
     
         18 . The method of  claim 10 , wherein the joint is a knee, elbow, wrist, ankle, hip, shoulder, or spine. 
     
     
         19 . The method of  claim 10 , wherein the inflammatory joint disease is arthritis, tendonitis, bursitis, inflammation of the ligament, synovitis, gout, and systemic lupus erythematosus. 
     
     
         20 . The method of  claim 19 , wherein the inflammatory joint disease is osteoarthritis. 
     
     
         21 . A method for treating inflammatory joint disease in a subject, said method comprising injecting into the inflamed joint a therapeutic anti-inflammatory composition comprising 1-500 μg of a bacterial or viral IL-10 expression construct, wherein the IL-10 expression construct comprises a bacterial or viral backbone and a nucleic acid sequence encoding interleukin-10; and 5-1000 μg D-mannose. 
     
     
         22 . The method of  claim 21 , wherein the D-mannose is administered concurrently with the IL-10 expression construct. 
     
     
         23 . The method of  claim 21 , wherein the De-mannose is administered up to ten days prior to administration of the IL-10 expression construct. 
     
     
         24 . The method of  claim 22 , wherein the nucleic acid sequence encoding interleukin-10 has an amino acid substitution for wildtype phenylalanine at amino acid position 129. 
     
     
         25 . The method of  claim 24 , wherein the amino acid substitution is selected from the group of serine, alanine, threonine or cysteine. 
     
     
         26 . The method of  claim 25 , wherein the nucleic acid sequence encoding interleukin-10 encodes IL-10 F129S . 
     
     
         27 . The method of  claim 22 , wherein the plasmid DNA comprises at least one nuclear targeting sequence 5′ to the IL-10 coding sequence. 
     
     
         28 . The method of  claim 22 , wherein the plasmid DNA comprises at least one nuclear targeting sequence 3′ to the IL-10 coding sequence. 
     
     
         29 . The method of  claim 22 , wherein the plasmid DNA comprises at least one nuclear targeting sequence both 5′ and 3′ to the IL-10 coding sequence. 
     
     
         30 . A method for treating inflammatory joint disease in a subject, said method comprising injecting into the inflamed joint a therapeutic anti-inflammatory composition comprising 1-500 μg of a bacterial or viral IL-10 expression construct, wherein the IL-10 expression construct comprises a bacterial or viral backbone, a nucleic acid sequence encoding IL-10 F129S , at least one nuclear targeting sequence either 5′ or 3′ or both to the IL-10 coding sequence; and 5-1000 μg D-mannose.

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