Protalix Switch over Trial
Protalix BioTherapeutics Announces First Patient Enrolled in Open-Label, Switchover Trial of prGCD for the Treatment of Gaucher Disease
Protalix BioTherapeutics, Inc. (Amex: PLX), has announced enrollment of the first patient in a worldwide, multi-center, open-label, switchover trial to assess the safety and efficacy of prGCD. prGCD is the Company’s proprietary plant cell expressed recombinant form of human glucocerebrosidase (GCD) that is in development for the treatment of Gaucher disease, a rare and serious lysosomal storage disorder in humans. The trial is designed to include 15 patients with Gaucher disease that are currently undergoing enzyme replacement therapy with imiglucerase (Cerezyme®).
Patients that are eligible for the switchover trial will be evaluated to establish the stability of their disease. In the trial, patients with stable disease will be switched from intravenous imiglucerase treatment every two weeks to intravenous infusions of prGCD every two weeks for a nine-month period. The prGCD dose administered to each patient will be equal to the patient’s previous imiglucerase dose and the infusions will be administered at selected investigational sites. At the end of the nine-month treatment period, all eligible patients will be offered the opportunity to enroll in the Company’s on-going extension study.
Addenbrooke's Hospital, Cambridge, UK will soon open as a site for the Protalix switch over trial.