Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) today announced that it has received approval from Israel's Ministry of Health to conduct a phase I clinical trial of Oral GCD (PRX-112), a Gaucher disease treatment product candidate. Oral GCD is a plant cell expressed form of the glucocerebrosidase enzyme (GCD) that is naturally encapsulated within carrot cells. The company expects to carry out the trial in two Israeli medical centers during the next month.
Protalix current Gaucher disease treatment Elelyso, which received US Food and Drug Administration (FDA) approval last year, is injectable.
Protalix president and CEO Dr. David Aviezer said, "The majority of currently diagnosed patients with Gaucher disease are treated with bi-weekly intravenous infusions of enzyme replacement therapy. Having a safe and effective orally available enzyme agent would potentially improve patients' quality of life without compromising on the benefits of enzyme therapy. Our clinical trial programs for IV administered plant cell-expressed GCD have already demonstrated that the enzyme is safe and effective in treating Gaucher disease. Now, in evaluating Oral GCD, our main goal is to achieve therapeutic levels of the enzyme in the bloodstream after oral consumption by patients."
The company expects the phase I trial to be completed during the second quarter of 2013.
Pre-clinical studies of oral GCD demonstrate the stability of the enzyme in the carrot cell and the capacity of the cell's cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, both rats and pigs fed with PRX 112, lyophilized carrot cells expressing GCD, have demonstrated enzyme levels in the plasma and accumulation of the active enzyme in target organs such as the spleen and liver.
Protalix executive VP R&D Dr. Yoseph Shaaltiel said, "Our animal studies have already demonstrated the capacity of plant cells to serve as a vehicle for oral administration of other therapeutic proteins. These proteins include for example, our plant cell-expressed antiTNF fusion protein, a plant cell version of etanercept (Enbrel). Given the results of our preclinical studies, we believe our Oral GCD clinical study will support our belief that we have developed a wider platform for oral protein delivery."
Published by Globes [online], Israel business news - www.globes-online.com - on March 7, 2013
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