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AssigneeAscendis Pharma Oncology Division A/S
InventorsDavid B. ROSEN, Luis ZUNIGA, Juha PUNNONEN, Lars HOLTEN-ANDERSEN, Kennett SPROGØE, Yang YANG-MALTEN, Torben LESSMANN, Nicola BISEK, Samuel WEISBROD, Sebastian STARK, Tobias VOIGT
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The present invention relates to a water-insoluble controlled-release pattern recognition receptor agonist (“PRRA”) for use in the treatment of a cell-proliferation disorder, wherein the water-insoluble controlled-release PRRA is administered by intra-tissue administration, and wherein the protein levels of at least one cytokine selected from the group consisting of IL-6, CCL2 and EL-10 in plasma has a more than 10-fold lower maximum protein level within 24 hours compared to an equivalent molar dose of the corresponding free PRRA upon intra/tissue administration; and to related aspects.
A water-insoluble controlled-release pattern recognition receptor agonist (“PRRA”) or its pharmaceutically acceptable salt or a pharmaceutical composition comprising such water-insoluble controlled-release PRRA or its pharmaceutically acceptable salt for use in the treatment of a cell-proliferation disorder, wherein the water-insoluble controlled-release PRRA is administered by intra-tissue administration, and wherein the protein level of at least one cytokine selected from the group consisting of IL-6, CCL2 and IL-10 in plasma has a more than 10-fold lower maximum protein level within 24 hours compared to an equivalent molar dose of the corresponding free PRRA upon intra-tissue administration.
A water-insoluble controlled-release PRRA, its pharmaceutically acceptable salt or a pharmaceutical composition comprising such water-insoluble controlled-release PRRA or its pharmaceutically acceptable salt for use in the treatment of a cell-proliferation disorder, wherein the water-insoluble controlled-release PRRA is administered by intra-tissue administration and wherein the maximum mRNA expression levels of at least 4 genes selected from the group consisting of TNF, IL1A, IL1B, IL10, IL6, IL12B, CCL2, CCL8, CCL3, CCL4, CXCL2, CCL20, CSF2, pan-IFNA subtype members, IFNB1, IL18, CCL5, CXCL10 and CXCL1 in peripheral blood mononuclear cells within 24 hours after such intra-tissue administration are more than 1.5-fold lower than after intra-tissue administration of an equivalent molar dose of the corresponding free PRRA.
A water-insoluble controlled-release PRRA or its pharmaceutically acceptable salt or a pharmaceutical composition comprising such water-insoluble controlled-release PRRA or its pharmaceutically acceptable salt for use in the treatment of a cell-proliferation disorder, wherein the water-insoluble controlled-release PRRA is administered by intra-tissue administration and wherein the maximum plasma level of free PRRA within 24 hours is at least 25-fold lower compared to the maximum plasma level within 24 hours after intra-tissue administration of an equivalent molar dose of the corresponding free PRRA.
A water-insoluble controlled-release PRRA or its pharmaceutically acceptable salt or a pharmaceutical composition comprising such water-insoluble controlled-release PRRA or its pharmaceutically acceptable salt for use in the treatment of a cell-proliferation disorder, wherein after intra-tissue administration of the water-insoluble controlled-release PRRA comprising 10 μg of free PRRA equivalents the maximum plasma concentration of free PRRA within 24 hours is less than 1.0 ng/ml.
Dependencies are inferred from the claim text.