Formulations of pegylated arginine deiminase
AssigneePolaris Group
InventorsBor-Wen WU, James THOMSON, Wen-Chin TSAI
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Abstract
The present disclosure relates to lyophilized formulations comprising pegylated arginine deiminase (ADI-PEG) and related reconstituted liquid compositions and methods of using the compositions for arginine depletion therapies, including for treatment of various cancers.
Claims20
A lyophilized formulation, comprising arginine deiminase-polyethylene glycol 20K (ADI-PEG 20), wherein the lyophilized formulation is at a pharmaceutically-acceptable pH, a histidine buffer at a concentration of about 1 to about 50 mM, sodium chloride, and sucrose at about 1 wt % to about 20 wt %, and wherein the ADI-PEG 20 retains at least 85%, 90% or 95% arginine deiminase (ADI) activity relative to a corresponding ADI-PEG 20 in a non-lyophilized liquid control composition after being stored as a lyophilized formulation over 3 months at a temperature of 2-8° C.
Dependencies are inferred from the claim text.