Protalix Expects Phase 1 Trial of PRX112 Complete in Q3

Protalix BioTherapeutics, Inc. PLX announced today 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.  "With Oral GCD, we are using the natural characteristics of plant cells to deliver active enzyme into the patient's blood stream," said Professor Ari Zimran, M.D., Director of the Gaucher Clinic in Shaare Zedek Medical Center, Jerusalem, Israel and lead clinical investigator. "We believe oral delivery of GCD has the potential to improve patients' quality of life without compromising the efficacy or safety of the treatment." 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 and accumulation of the active enzyme in target organs such as the spleen and liver. Dr Einat Brill Almon, the Company's Senior Vice President, Product Development, added: "We successfully demonstrated the ability of plant cells to act as an oral delivery mechanism for a number of therapeutic proteins in our animal studies. We believe that the results of our clinical trial of Oral GCD will provide additional support for our belief that this oral delivery mechanism can be developed for other proteins used to treat other indications."