CARMIEL, Israel, Sept. 07, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today 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.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration(FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights. Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others.
Forward-Looking Statements
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