The present invention relates to the field of
biotechnology,
medicine, in particular,
oncology and pharmaceuticals, and is directed to ready-to-use dosage forms of a medicinal product for combination
gene-directed
enzyme prodrug therapy—
immune therapy of human
solid malignant neoplasms.Two variants of two-component dosage forms of the medicinal product are proposed. In the first variant, the composition of the medicinal product includes the first and second containers, the first container containing the first component containing the pCMV-HSVtk-hGM-CSF therapeutic
plasmid DNA in a therapeutically effective amount in the form of a frozen
aqueous solution, and the second container containing the second component containing the polyethyleneimine-
polyethylene glycol-TAT
peptide block
copolymer in a therapeutically effective amount in the form of a frozen
aqueous solution. A ready-to-use solution for injection, intended for administration to a patient, is prepared ex tempore by thawing the referenced two components and mixing them.In the second variant, the composition of the medicinal product includes the first and second containers, the first container containing the first component containing the pCMV-HSVtk-hGM-CSF therapeutic
plasmid DNA in a therapeutically effective amount in the form of a lyophilisate, and the second container containing the second component containing the polyethyleneimine-
polyethylene glycol-TAT
peptide block
copolymer in a therapeutically effective amount in the form of a frozen
aqueous solution. A ready-to-use solution for injection intended for administration to a patient is prepared ex tempore by reconstituting the first component by adding water, thawing the second component and mixing them.The proposed dosage forms can be used for the treatment of human
solid malignant neoplasms. The two proposed dosage forms demonstrate high stability and retain their therapeutic
efficacy for at least 18 months.