Long lasting drug formulations

摘要

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.

主权项

1. A method of treating anemia in a human subject in need over a sustained time period comprising the steps of:
(a) providing at least one genetically modified autologous dermal micro-organ that expresses and secretes erythropoietin, wherein said dermal micro-organ is an intact explant of living tissue that maintains the micro-architecture and the three dimensional structure of the dermal tissue from which it was derived and consists essentially of a plurality of dermal components and lacking a complete epidermal layer, wherein said genetic modification of said dermal micro-organ comprises using a helper-dependent adenovirus vector comprising a nucleic acid sequence encoding erythropoietin operably linked to one or more regulatory sequences, and wherein said dermal micro-organ or said genetically modified dermal micro-organ are maintained in vitro for at least between 1-7 days; (b) determining erythropoietin secretion levels of said at least one genetically modified micro-organ in vitro; and (c) implanting said at least one genetically modified autologous dermal micro-organ in said human subject at an effective dosage, wherein said method increases or maintains hemoglobin levels in said subject and said increased or maintained hemoglobin levels are maintained for at least three months.