Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced that the first patient has been treated in the Company’s phase I clinical trial of PRX-112, or Oral GCD, the Company’s orally-administered enzyme 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. Protalix expects the phase I trial to be completed during the third quarter of 2013.
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 receive 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.
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