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The Phase III extension trial is a follow-on study to the company's on-going pivotal Phase III clinical trial, which is evaluating the safety and efficacy of prGCD in treatment-naive patients of Gaucher disease, a lysosomal storage disorder in humans.
The home care treatment program allows patients in the Phase III extension trial to receive intravenous treatments of prGCD in the comfort of their own home, at a physician's discretion and under the supervision of a registered nurse. Upon drug approval, the company intends to continue this program as part of a patient care program designed to assist, support and educate patients receiving prGCD therapy.
The Phase III clinical trial of prGCD is a multi-center, randomized, double-blind, parallel group, dose-ranging study to assess the safety and efficacy of prGCD in treatment-naive patients suffering from Gaucher disease. In the trial, patients are selected randomly for one of two dosing arms and receive intravenous infusions of prGCD every two weeks for nine months.
The primary endpoint of the study is a percent change from baseline of spleen volume after nine months, as measured by magnetic resonance imaging. Enrollment in this trial was completed in December 2008. The company plans to announce topline results of the trial and file a new drug application with the FDA in the fourth quarter of 2009.
Einat Brill-Almon, senior vice president of product development at Protalix, said: "We recently enrolled our first patient in the home care treatment program. We feel physician and patients' willingness to allow prGCD to be administered in the home setting underscores their comfort level with respect to our drug. As we continue to plan for the marketing and commercialization of prGCD, we look forward to rolling out our full patient care program."
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