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Protalix BioTherapeutics Receives FDA IND Clearance To Initiate A Phase I/II Study Of Fabry Disease Patients With PRX-102, A Modified Enzyme Replacement Therapy

CARMIEL, Israel, Aug. 13, 2012 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced today that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate clinical trials of PRX-102. The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.

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 two 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.

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