Protalix announces Phase 1 trial of PRX112

Protalix Biotherapeutics has announced that the first patient has been treated as part of the company's phase I clinical trial of PRX-112 or Oral GCD.

The product is the business' orally-administered enzyme product candidate for the treatment of Gaucher disease and is a plant cell expressed form of GCD that is naturally enclosed within carrot cells.

Protalix believes that the phase I trial will be completed during 2013's third quarter, with the phase I clinical trial existing as an open label safety and pharmacokinetic study that aims to analyse 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, along with three consecutive daily administrations in the second cohort.

Pre-clinical studies of oral GCD show 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.

Professor Ari Zimran, director of the Gaucher Clinic in Shaare Zedek Medical Center, Jerusalem, Israel and lead clinical investigator, said: "With Oral GCD, we are using the natural characteristics of plant cells to deliver active enzyme into the patient's blood stream.

"We believe oral delivery of GCD has the potential to improve patients' quality of life without compromising the efficacy or safety of the treatment."

Dr Einat Brill Almon, the company's senior vice president, product development, said: "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."

Posted by Ben Evans