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prGCD is currently being evaluated for the treatment of Gaucher disease in a Phase III clinical trial which is scheduled to end by September 2009. The company plans to announce topline results from the Phase III trial in October 2009, and to complete filing of a new drug application with the FDA before the end of 2009.
In addition, after the FDA's recent approval of the company's treatment protocol for prGCD, the company filed applications for medical Institutional Review Board approvals in hospitals worldwide and expects to start treating patients under the extended access treatment protocol.
David Aviezer, president and CEO of Protalix, said: "The FDA's orphan drug designation further strengthens our prGCD program for treating Gaucher disease by offering important clinical development and commercialization benefits."
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