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|Protalix BioTherapeutics Presents Positive Results from the Phase I/II Open-Label Extension Trial for PRX-102 at the New Horizons for Fabry Disease Conference|
Continued to Demonstrate Improvement across all Key Fabry Disease Parameters at 24 Months
Low Incidence of Treatment Induced Anti-Drug Antibodies which Reversed Entirely Following 12 Months of Treatment without Recurrence
Sixteen male and female adult patients were enrolled in the phase I/II clinical trial across three dosing cohorts (0.2 mg/kg, 1mg/kg and 2mg/kg) and received intravenous infusions of PRX-102 every two weeks. The two-year data described in this press release includes data from 11 patients enrolled and treated in the long-term open-label extension trial. Patients who did not continue in the extension trial included female patients who became or planned to become pregnant, and therefore were unable to continue in accordance with the study protocol, and patients that relocated to a location where treatment was not available under the clinical study.
“The long-term results at 24 months indicate that PRX-102 continues to demonstrate a remarkable improvement and stability across all key Fabry disease parameters. PRX-102 was also well tolerated, with a very low incidence of treatment induced anti-drug antibodies that were reversible with only a transient and reversible effect on pharmacokinetics,” commented Prof.
Regarding efficacy, the following data was recorded at 24 months:
Regarding safety, the following data was recorded:
“PRX-102 is currently being evaluated globally in three phase III clinical trials,” said Mr.
A copy of Professor Schiffmann’s presentation will be posted in the Presentations page of the Investors tab of the Company’s corporate website.
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
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