The company’s molecule is a proprietary plant cell recombinant form of a human gene.
Protalix Biotherapeutics Inc. (AMEX:PLX) has obtained US Food and Drug Administration (FDA) approval for the final design of its Phase III clinical trial for prGCD for the treatment of Gaucher disease, a lysosomal storage disorder in humans. The FDA approved the trial under its Special Protocol Assessment (SPA) process./ The company plans to start the trial during the third quarter of 2007.
prGCD is a proprietary plant cell expressed recombinant form of human gene Glucocerebrosidase (GCD). It is a biosimilar product to an existing drug, developed by Genzyme Corp. (Nasdaq:GENZ); Protalix was therefore able to leapfrog Phase II clinical trials.
The trial will be Protalix’s large-scale effectiveness human trial of prGCD. The chances of success are much greater than usual for Phase III trials because of the molecule’s similarity to Genzyme’s molecule, whose effective has already been demonstrated.
Published by Globes [online], Israel business news - www.globes.co.il - on July 15, 2007
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