Protalix Biotherapeutics, Inc.
Protalix Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease
Published in Medical Letter on the CDC and FDA, October 4th, 2009
Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX), announced the completion of its pivotal Phase III trial for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. The trial enrolled a total of 31 patients across Europe, North America, South America, Israel and South Africa. No serious adverse events were reported in this trial. The Company plans to announce top-line results from this study in October 2009 and expects to complete its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) before the end of the year.
The pivotal Phase III clinical trial of prGCD...
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