Protalix (PLX) Gets FDA Okay for PRX-102 Phase I/II Study of Fabry Disease
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Protalix BioTherapeutics, Inc. (NYSE: PLX) received FDA clearance of its Investigational New Drug (IND) application to initiate clinical trials of PRX-102.
The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012. The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.
PRX-102 is a proprietary plant cell-expressed, chemically modified, recombinant alpha-galactosidase-A in development as a long-term enzyme replacement therapy (ERT) for the treatment of Fabry disease. The phase I/II clinical trial is designed as a multi-center, open label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics and efficacy of PRX-102 in adult Fabry patients.
The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012. The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.
PRX-102 is a proprietary plant cell-expressed, chemically modified, recombinant alpha-galactosidase-A in development as a long-term enzyme replacement therapy (ERT) for the treatment of Fabry disease. The phase I/II clinical trial is designed as a multi-center, open label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics and efficacy of PRX-102 in adult Fabry patients.
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