The company’s Phase III clinical trial of prGCD is designed as a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in naive patients suffering from Gaucher disease.
In the trial, patients are selected randomly for one of two dosing arms and receive IV infusions every two weeks for nine months. The primary endpoint of the study is the change, calculated in percentages, in spleen volume from baseline, as measured by magnetic resonance imaging.
The company’s pivotal Phase III clinical trial of prGCD is being conducted under a special protocol assessment agreement with the FDA.
David Aviezer, president and CEO of Protalix, said: “The completion of enrollment signifies that we are one important step closer to our goal of commercializing prGCD. We expect to analyze the results of this key study and to report the results in the second half of 2009. We anticipate submitting a new drug application to the FDA and other comparable regulatory agencies in the fourth quarter of 2009.”