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news.Protalix BioTherapeutics has treated the first patient in its Phase III clinical trial of the company's lead candidate for the treatment of Gaucher disease, a lysosomal storage disorder in humans.
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The product, prGCD, is a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD).
The Phase III clinical trial will take place in centers in the US, Israel and other locations worldwide. Professor Ari Zimran, director of the Gaucher Clinic at Shaare Zedek Medical Center in Jerusalem, Israel, will serve as principal investigator for the trial. The trial design consists of 30 male and female patients with Gaucher disease in a randomized, double- blind, dose ranging study, with two parallel groups.
Dr David Aviezer, president and CEO of Protalix, stated: “Enrolling our first patients in this phase III clinical trial represents a significant milestone as we work toward our goal of commercializing prGCD, our proprietary treatment for Gaucher disease. After extensive research from the committed members of our team, we believe that we have developed a treatment that will not only be effective, but also safe and cost efficient when compared to current treatment options.”