Methods and compositions for interferon therapy
First Claim
1. A pharmaceutical composition comprising 1) a delivery enhancing agent selected from the group consisting of SYN3 and SYN3 homologs and 2) an interferon protein or an interferon gene delivery system, wherein the gene delivery system contains a gene for the interferon and wherein the gene for the interferon is operably linked to a genetic regulatory element which modulates expression of the gene.
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Abstract
Methods and pharmaceutical compositions for administering protein or gene therapy to tissues or organs having an epithelial cell layer are provided. A protein or nucleic acid encoding the protein is administered to the target tissue or organ in combination with treatment with a delivery enhancing agent which increases the delivery of the interferon or nucleic acid to the cells of the target tissues or organs. The methods and combinations are particularly useful in the treatment of cancers and other conditions responsive to interferon therapy. An exemplary method comprises the transurethral intravesical administration to the bladder of a therapeutically effective amount of a pharmaceutical composition comprising an alpha-interferon or a gene delivery system encoding the interferon and SYN3 or a SYN3 homolog or analog. In the urinary bladder, as much as a 10 to 1000 fold increased in interferon levels and activity may be observed with the use of a SYN3 formulation as opposed to a PBS formulation of the same interferon protein or interferon gene delivery system.
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Citations
58 Claims
- 1. A pharmaceutical composition comprising 1) a delivery enhancing agent selected from the group consisting of SYN3 and SYN3 homologs and 2) an interferon protein or an interferon gene delivery system, wherein the gene delivery system contains a gene for the interferon and wherein the gene for the interferon is operably linked to a genetic regulatory element which modulates expression of the gene.
- 12. The composition of 10, wherein m and n are each 1.
- 20. A method for delivering interferon to a mammalian subject, said method comprising administering to the epithelial tissue or organ of the subject a therapeutically effective amount of a pharmaceutical composition comprising a delivery enhancing agent selected from the group consisting of SYN3 and SYN3 homologues and administering interferon or an interferon gene delivery system, wherein the gene delivery system contains a gene for the interferon and wherein the gene for the interferon is operably linked to a genetic regulatory element which modulates expression of the gene.
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46. A kit comprising:
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a first container containing SYN3 or a SYN3 homologue capable of enhancing the delivery of an interferon; and
a second container containing the interferon or a gene delivery system, wherein the gene delivery system contains a gene for the interferon and wherein the gene for the interferon is operably linked to a genetic regulatory element which modulates expression of the gene. - View Dependent Claims (47, 48, 49, 50)
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51. A pharmaceutical composition comprising a gene delivery enhancing agent selected from the group consisting of SYN3 and a SYN3 homolog;
- and a gene delivery system, wherein the gene delivery system contains a gene for interferon and wherein the gene for interferon is operably linked to a genetic regulatory element which modulates expression of the gene.
- View Dependent Claims (52, 53, 54, 55, 57, 58)
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56. A method for delivering an interferon to a mammalian subject, said method comprising administering to the epithelial tissue or organ of the subject a therapeutically effective amount of a pharmaceutical composition comprising a delivery enhancing agent selected from the group consisting of SYN3 and SYN3 homologues and a gene delivery system, wherein the gene delivery system contains a gene for the interferon and wherein the gene for the interferon is operably linked to a genetic regulatory element which modulates expression of the gene.
Specification