CARMIEL, Israel, March 7, 2013 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that it has received approval from the Israeli Ministry of Health to initiate a phase I clinical trial of PRX-112, or Oral GCD, the Company's orally-administered product candidate for the treatment of Gaucher disease. Oral GCD is a plant cell expressed form of the glucocerebrosidase enzyme (GCD) that is naturally encapsulated within carrot cells and administered orally. The Company anticipates initiating this trial in two Israeli medical centers during the next month.
"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," commented Dr. David Aviezer, Protalix BioTherapeutics' President and Chief Executive Officer. "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 phase I clinical trial is an open label safety and pharmacokinetic study designed to assess the delivery of prGCD after oral administration of Oral GCD in 12 Gaucher patients. Subjects will receive 250mL of re-suspended carrot cells in a single oral administration during the first cohort of the trial and three consecutive daily administrations during the second cohort of the trial. 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.