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news.Protalix BioTherapeutics has reached an agreement with the FDA on the final design of its pivotal phase III clinical trial for its lead product candidate, prGCD. The company expects to initiate enrollment of patients for its phase III clinical trials during the third quarter of 2007.
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prGCD is a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment of Gaucher disease, a lysosomal storage disorder in humans.
The phase III clinical trial will take place in leading medical centers in the US, Israel, where approval from the Israeli Ministry of Health has been received, and other locations worldwide. The clinical trial will initially consist of male and female adult patients with Gaucher disease.