Immunoglobulin-replacement drug undergoes 2nd trials
A drug that could remove the need for donor immunoglobulin in the treatment of hemolytic diseases is to enter a second phase of trials, joint-developers, Sweden's Biovitrum and Denmark's Symphogen have announced.
The study will be dose-adjusting, partly double-blind and randomized, and will compare the drug, Sym001, with an active control. The primary objective is to test Sym001's ability to clean out RhD-positive cells from the circulation of RhD-negative volunteers.
The drug is indicated for the prevention of hemolytic disease in RhD-positive newborns with RhD-negative mothers by anti-D prophylaxis, as well as the treatment of idiopathic thrombocytopenic perpura.
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