Protalix BioTherapeutics (PLX) to Present Data on PRX-102 in Fabry Disease; Continues Phase 3 Enrollment

September 7, 2016 7:06 AM EDT

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Protalix BioTherapeutics, Inc. (NYSE: PLX) announced an oral presentation highlighting the results of the phase I/II clinical trial of PRX-102 for the treatment of Fabry disease will be given at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium being held September 6-9, 2016 in Rome, Italy.

The oral presentation titled, “A novel treatment for Fabry disease – IV administration of plant derived alpha-gal-a enzyme safety and efficacy, 1 year experience,” will be given by Raphael Schiffmann, M.D., Lead Investigator at the Metabolic Neurology Branch of the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health, and a principal investigator of the phase I/II clinical trial of PRX-102, on Thursday, September 8, 2016 between 10:30am – 12:00pm GMT. A copy of the presentation will be available following the conference on the Company’s website under the presentations tab of the investor page.

PRX-102 is a recombinant, plant cell expressed, pegylated, modified version of the human alpha-Galactosidase-A enzyme. The phase I/II clinical trial is an open-label, dose-ranging study designed to treat up to 18 naïve male and female adult patients across three dosing cohorts (0.2 mg/kg, 1mg/kg and 2mg/kg), with intravenous infusions of PRX-102 every two weeks. The clinical results indicate that PRX-102 demonstrated improvements or stabilization across all disease parameters including, plasma Lyso-Gb3, kidney function, cardiac function and pain. Additionally, PRX-102 was well tolerated, with the majority of adverse events being mild and moderate.

Currently, all 16 patients enrolled in the phase I/II trial continue to receive 1 mg/kg of PRX-102 in an open label extension trial. The Company is recruiting patients for a phase III pivotal trial of PRX-102 for the treatment of Fabry disease in centers in the United States.



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