Protalix BioTherapeutics Receives Clearance to Initiate Study
Protalix BioTherapeutics, Inc. recently announced it has received clearance of its
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.
“We are very excited to begin the clinical development of PRX-102, which we believe may prove to present an important improvement to the well being of patients with Fabry disease, a rare, genetic lysosomal storage disorder affecting approximately 8,000 people globally,” said Dr. David Aviezer, Protalix’s President and Chief Executive Officer. “We have designed PRX-102 as a potentially improved version of the currently marketed enzyme replacement therapies for Fabry disease given its potential to be a more stable, potent, and specific enzyme. This enzyme is expressed through ProCellEx, our proprietary, plant cell-based protein expression system. We are also excited that another biotherapeutic protein evolving from our ProcellEx platform technology is anticipated to enter clinical development shortly.”
Eighteen adult Fabry patients will be enrolled in one of three dosing groups. Each patient will receive intravenous infusions of PRX-102 every 2 weeks for 12 weeks, and will be infused sequentially and stepwise in order to evaluate safety. Exploratory efficacy parameters will be evaluated as a preliminary assessment. Following the end of the trial, the company intends to offer patients the option to continue to receive PRX-102 in an open-label extension study.
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, ELELYSO (taliglucerase alfa), was approved for marketing by the US FDA on May 1, 2012, and is partnered with Pfizer Inc. for worldwide development and commercialization, excluding
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