prGCD - plant cell expressed recombinant Glucocerebrosidase enzyme (GCD) may be used for treating Gaucher disease

Protalix Biotherapeutics proudly announced that prGCD, their lead proprietary product candidate,could be used for the treatment of Gaucher disease.

On their website they mention "We have reached an agreement with the United States Food and Drug Administration on the final design of the pivotal phase iii clinical trial for prGCD through the FDA's Special Protocol Assesment (SPA) process. We have completed enrollment for this study in December 2008 and expect to report results of the clinical trial in the second half of 2009. We anticipate submitting a New Drug Application (NDA) for prGCD to the FDA and other comparable regulatory agencies in other countries in the fourth quarter of 2009. We are treating patients in our pivotal phase III clinical trial in North America, South America, Israel, Europe and South Africa."

This may be a big breakthrough in the management of this otherwise fatal condition.