CARMIEL, Israel, Aug. 27 ProtalixBioTherapeutics, Inc. (Amex: PLX), today announced that it has treated thefirst patient in its phase III clinical trial of the Company's lead productcandidate, prGCD, a proprietary plant cell expressed recombinant form of humanGlucocerebrosidase (GCD) for the treatment of Gaucher disease, a lysosomalstorage disorder in humans.
The phase III clinical trial will take place in centers in the UnitedStates, Israel and other locations worldwide. Professor Ari Zimran, Directorof the Gaucher Clinic at Shaare Zedek Medical Center in Jerusalem, Israel,will serve as principal investigator for the trial. The trial design consistsof 30 male and female patients with Gaucher disease in a randomized, double-blind, dose ranging study, with two parallel groups.
Dr. David Aviezer, President and CEO of Protalix, stated, "Enrolling ourfirst patients in this phase III clinical trial represents a significantmilestone as we work toward our goal of commercializing prGCD, our proprietarytreatment for Gaucher disease. After extensive research from the committedmembers of our team, we believe that we have developed a treatment that willnot only be effective, but also safe and cost efficient when compared tocurrent treatment options. We look forward to monitoring the progress of ourtrial and the potential benefits for our participating patients."
Professor Ari Zimran added, "With the treatment of the first patient inthe phase III clinical trial, we are one step closer to providing anothertreatment option for those who suffer from Gaucher disease. Progress to datehas been very encouraging, and we expect to continue to see the benefits andadvantages of prGCD in this phase III clinical trial."
About Protalix BioTherapeutics, Inc.
Protalix is a clinical stage biopharmaceutical company. Its goal is tobecome a fully integrated biopharmaceutical company focused on focused on thedevelopment and commercialization of proprietary recombinant therapeuticproteins to be expressed through its proprietary plant cell based expressionsystem. Protalix's ProCellEx(TM) presents a proprietary method for theexpression of recombinant proteins that Protalix believes is safe and scalableand will allow for the cost-effective, industrial-scale production ofrecombinant therapeutic proteins. Protalix has reached an agreement with theUnited States Food and Drug Administration, through its Special ProtocolAssessment (SPA) process, on the final design of the pivotal phase IIIclinical trial in the United States of Protalix's lead product candidate,prGCD, for enzyme replacement therapy of Gaucher disease, a lysosomal storagedisorder in humans. Protalix is also advancing additional recombinantbiopharmaceutical drug development programs.
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To the extent that statements in this press release are not strictlyhistorical, all such statements are forward-looking, and are made pursuant tothe safe-harbor provisions of the Private Securities Litigation Reform Act of1995. These forward-looking statements are subject to known and unknown risksand uncertainties that may cause actual future experience and results todiffer materially from the statements made. These statements are based on ourcurrent beliefs and expectations as to such future outcomes. Drug discoveryand development involve a high degree of risk. Factors that might cause sucha material difference include, among others, uncertainties related to theability to attract and retain partners for our technologies and products underdevelopment, the identification of lead compounds, the successful preclinicaldevelopment of our products, the completion of clinical trials, the reviewprocess of the FDA, foreign regulatory bodies and other governmentalregulation, and other factors described in our filings with the Securities andExchange Commission. The statements are valid o