TxCell receives EU Orphan Drug Designation for Col-Treg in the treatment of non-infectious uveitis
TxCell SA announced that the European Commission (EC) has granted Orphan Drug Designation to TxCell's investigational medicinal product Col-Treg, a personalized T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of autoimmune uveitis.
"Obtaining orphan drug designation for Col-Treg in the European Union is a recognition of the therapeutic potential of Col-Treg in autoimmune uveitis. Whilst this is a rare disease, it is a leading cause of blindness in the developed world. TxCell estimates around 30,000 autoimmune uveitis patients per year in the US and EU alone, for whom existing treatments do not work, could benefit significantly from the development of Col-Treg," said Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs, TxCell. "We are moving rapidly to undertake a placebo-controlled, dose-ranging proof of principle clinical study in autoimmune uveitis. This is planned to start in the first half of 2015. The top line results of this study are expected mid-2016."
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