Protalix BioTherapeutics, Inc. (NYSE MKT: PLX) announced today positive interim data from the Company's phase I/II clinical trial of 1mg/kg of PRX-102 for the treatment of Fabry disease. PRX-102 is a recombinant plant cell expressed, chemically modified version of the human alpha-Galactosidase-A enzyme.
"We are very pleased with the positive results from the 1mg cohort for PRX-102," commented Mr. Moshe Manor, Protalix's President and Chief Executive Officer. "The efficacy results for the 1mg/kg cohort appear even more robust than those previously announced for the 0.2mg cohort, while maintaining a favorable safety profile with a very low level of antibody formation."
The phase I/II clinical trial of PRX-102 for the treatment of Fabry disease is an open-label, dose-ranging study treating up to 18 naïve male and female adult patients. The three dose cohorts include dosage groups of 0.2 mg/kg, 1mg/kg and 2mg/kg with intravenous infusions of PRX-102 every two weeks, with a six-month efficacy follow up period.
This interim analysis includes 6 patients enrolled in the 1mg/kg dose group at six
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