Morphosys gets Dutch ok for Ph I MOR103 trial
German synthetic antibody specialist MorphoSys AG says that Dutch regulatory authorities have granted approval for Phase I studies of the HuCAL-derived antibody MOR103 in inflammatory disorders. In addition, the firm said that it has received a manufacturing license from the Bavarian government to release clinical trial material for MOR103.
MorphoSys explained that MOR103 is a fully-human antibody directed against granulocyte macrophage-colony-stimulating factor. GM-CSF has been implicated in the auto-immune inflammation associated with disorders such as rheumatoid arthritis and, as such, is believed to represent a suitable therapeutic target. The firm added that the approved Phase I will be a randomized, double-blind, placebo-controlled, single-ascending-dose trial in healthy volunteers and is intended to establish MOR103's safety and pharmacokinetic characteristics.
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