LONG LASTING DRUG FORMULATIONS
First Claim
1. A long-lasting erythropoietin formulation comprising at least one genetically modified micro-organ that expresses and secretes erythropoietin, said micro-organ comprising a helper-dependent adenovirus vector, said vector comprising a nucleic acid sequence encoding erythropoietin operably linked to one or more regulatory sequences, wherein said nucleic acid comprises SEQ ID No. 11.
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Accused Products
Abstract
The present invention is directed to long-lasting erythropoietin therapeutic formulations and their methods of use wherein the formulation comprises a genetically modified micro-organ that comprises a vector which comprises a nucleic acid sequence operably linked to one or more regulatory sequences, wherein the nucleic acid sequence encodes erythropoietin.
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Citations
20 Claims
- 1. A long-lasting erythropoietin formulation comprising at least one genetically modified micro-organ that expresses and secretes erythropoietin, said micro-organ comprising a helper-dependent adenovirus vector, said vector comprising a nucleic acid sequence encoding erythropoietin operably linked to one or more regulatory sequences, wherein said nucleic acid comprises SEQ ID No. 11.
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3. A method of treating anemia in a human subject in need over a sustained time period comprising the steps of:
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a. providing at least one genetically modified micro-organ that expresses and secretes erythropoietin, said micro-organ comprising a helper-dependent adenovirus vector comprising a nucleic acid sequence encoding erythropoietin operably linked to one or more regulatory sequences; b. determining erythropoietin secretion levels of said at least one genetically modified micro-organ in vitro; c. implanting said at least one genetically modified micro-organ in said human subject at an effective dosage; and d. measuring hemoglobin levels in the blood of said subject; wherein the measured hemoglobin levels in said subject are maintained at 9-11 g/dl in at least 50% of the measurements for at least one month. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A method of increasing or maintaining physiological hemoglobin levels in a human subject over a sustained period of time comprising the steps of:
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a. providing at least one genetically modified micro-organ that expresses and secretes erythropoietin, said micro-organ comprising a helper-dependent adenovirus vector comprising a nucleic acid sequence encoding erythropoietin operably linked to one or more regulatory sequences; b. determining erythropoietin secretion levels of said at least one genetically modified micro-organ in vitro; c. implanting said at least one genetically modified micro-organ in said subject at an effective dosage; and d. measuring hemoglobin levels in the blood of said subject, wherein said increased or maintained physiological hemoglobin levels in said subject are maintained at 9-11 g/dl in at least 50% of the measurements for at least one month. - View Dependent Claims (19, 20)
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Specification