PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[genisi]

Protalix BioTherapeutics, Inc. Receives Special Protocol Assessment Approval from FDA for its Phase III Clinical Study of prGCD
Friday July 13, 3:23 pm ET

http://biz.yahoo.com/prnews/070713/clf059.html?.v=67&printer=1

Company Expects to Begin Enrolling Gaucher Disease Patients for Phase III Clinical Trials of prGCD in Third Quarter of 2007

CARMIEL, Israel, July 13 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (Amex: PLX - News) today announced that it has reached an agreement with the United States Food and Drug Administration on the final design of its pivotal phase III clinical trial for its lead product candidate, prGCD, through the FDA's Special Protocol Assessment (SPA) process. The Company expects to initiate enrollment of patients for its phase III clinical trials during the third quarter of 2007.

prGCD is a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment of Gaucher disease, a lysosomal storage disorder in humans.

The phase III clinical trial will take place in leading medical centers in the United States, Israel, where approval from the Israeli Ministry of Health has been received, and other locations worldwide. The clinical trial will initially consist of male and female adult patients with Gaucher disease.

About Protalix BioTherapeutics, Inc.
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