Oral administration of therapeutic agent coupled to transporting agent
First Claim
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1. A process for production of insulin in a diabetic mammal by provision of a transdifferentiating moiety including at least one homeogene operably linked to a promoter, which induces transdifferentiation of host cells in vivo to instigate the formation of insulin producing cells comprising:
- providing at least one transporting agent effective for enabling widespread distribution, systemic expression and sustained delivery of said transdifferentiating moiety via said natural gastrointestinal pathway;
forming a distributable moiety by coupling said transporting agent, at least one compound effective for protecting said transdifferentiating moiety within said natural gastrointestinal pathway, and said transdifferentiating moiety in a manner effective to enable widespread distribution, systemic delivery and sustained expression upon intracellular absorption via said natural gastrointestinal pathway;
orally administering said distributable moiety by way of a natural gastrointestinal pathway;
transporting said distributable moiety in vivo via said natural gastrointestinal pathway, whereby said transdifferentiating moiety is included within essentially all cells of said subject; and
transdifferentiating host cells to instigate the formation of insulin producing cells, whereby insulin is produced by said mammal in amounts effective to achieve controlled glycemia.
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Abstract
The present invention is directed toward a composition for widespread distribution, systemic expression and sustained delivery of a therapeutic or transdifferentiating agent and to a process for administration of said agent via a natural gastrointestinal pathway. More particularly, the invention discloses a composition for the administration of oral gene therapy and a process for its production and use.
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Citations
29 Claims
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1. A process for production of insulin in a diabetic mammal by provision of a transdifferentiating moiety including at least one homeogene operably linked to a promoter, which induces transdifferentiation of host cells in vivo to instigate the formation of insulin producing cells comprising:
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providing at least one transporting agent effective for enabling widespread distribution, systemic expression and sustained delivery of said transdifferentiating moiety via said natural gastrointestinal pathway;
forming a distributable moiety by coupling said transporting agent, at least one compound effective for protecting said transdifferentiating moiety within said natural gastrointestinal pathway, and said transdifferentiating moiety in a manner effective to enable widespread distribution, systemic delivery and sustained expression upon intracellular absorption via said natural gastrointestinal pathway;
orally administering said distributable moiety by way of a natural gastrointestinal pathway;
transporting said distributable moiety in vivo via said natural gastrointestinal pathway, whereby said transdifferentiating moiety is included within essentially all cells of said subject; and
transdifferentiating host cells to instigate the formation of insulin producing cells, whereby insulin is produced by said mammal in amounts effective to achieve controlled glycemia. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A process for production of insulin in a diabetic mammal by provision of an insulin producing moiety containing at least one insulin producing DNA linked to a promoter, which induces in vivo formation of insulin comprising:
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providing at least one transporting agent effective for enabling widespread distribution, systemic expression and sustained delivery of said insulin producing moiety via said natural gastrointestinal pathway;
forming a distributable moiety by coupling said transporting agent, at least one compound effective for protecting said insulin producing moiety within said natural gastrointestinal pathway, and said insulin producing moiety in a manner effective to enable widespread distribution, systemic delivery and sustained expression upon intracellular absorption via said natural gastrointestinal pathway;
orally administering said distributable moiety by way of a natural gastrointestinal pathway; and
transporting said distributable moiety in vivo via said natural gastrointestinal pathway, wherein said insulin producing moiety is included within essentially all cells of said subject;
whereby insulin is encoded by said mammal in amounts effective to achieve controlled glycemia. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15)
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16. A process for production of a therapeutic agent in a mammal in need thereof by provision of a therapeutic agent producing moiety containing at least one therapeutic agent producing DNA linked to a promoter, which induces in vivo formation of said therapeutic agent comprising:
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providing at least one transporting agent effective for enabling widespread distribution, systemic expression and sustained delivery of said therapeutic agent producing moiety via said natural gastrointestinal pathway;
forming a distributable moiety by coupling said transporting agent, at least one compound effective for protecting said therapeutic agent producing moiety within said natural gastrointestinal pathway, and said therapeutic agent producing moiety in a manner effective to enable widespread distribution, systemic delivery and sustained expression upon intracellular absorption via said natural gastrointestinal pathway;
orally administering said distributable moiety by way of a natural gastrointestinal pathway; and
transporting said distributable moiety in vivo via said natural gastrointestinal pathway, wherein said therapeutic agent producing moiety is included within essentially all cells of said subject;
whereby said therapeutic agent is encoded by said mammal in amounts effective to ameliorate a particular physiological condition. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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Specification