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news.Biopharmaceutical company Protalix BioTherapeutics has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical trials of PRX-102.
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The Company is planning to enrol 18 Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.
As part of the trial, the enrolled patients will receive intravenous infusions of PRX-102 every two weeks for 12 weeks and the safety of the drug will be evaluated simultaneously.
PRX-102 is a proprietary plant cell-expressed, chemically modified, recombinant alpha-galactosidase-A in development as a long-term enzyme replacement therapy (ERT) to treat Fabry disease.
Protalix president and CEO David Aviezer said the company is very excited to begin the clinical development of PRX-102, which Protalix believes may prove to present an improvement to the well being of patients with Fabry disease, a rare, genetic lysosomal storage disorder affecting approximately 8,000 people globally.
"This enzyme is expressed through ProCellEx(R), our proprietary, plant cell-based protein expression system,” Aviezer added.