Protalix Concludes PRX-105 Phase I Clinical Trial

The trial established the pharmacokinetics of the protein and demonstrated that single dose, intravenous administration of PRX-105 is safe and well tolerated.

Protalix plans to perform additional safety studies in healthy volunteers and animals in collaboration with civil and military agencies in the US and Israel, for which discussions have been initiated. Given the nature of the biodefense indications for which the company is developing PRX-105, efficacy trials of PRX-105 in humans (Phase II and Phase III) are not required.

Protalix claimed that the Phase I clinical trial of PRX-105 is a first in human, open label, non-randomised, single-dose study. PRX-105 is administered intravenously by slow bolus injection to 10 healthy volunteers in the trial.

The trial is being conducted in collaboration with Hermona Soreq, from the Hebrew University in Jerusalem, Israel. The production of PRX-105 is based on patents that were licensed to Protalix by Yissum, the Technology Transfer company of the Hebrew University, Jerusalem.

Pre-clinical studies have indicated that PRX-105 protects animals exposed to organophosphate nerve gas agent analogs, in both the prophylactic and post-exposure settings.

David Aviezer, president and CEO of Protalix, said: “We are very pleased with the favorable safety and pharmacokinetic results from our Phase I clinical trial of PRX-105. The positive results also provide further validation of the safety and breadth of our ProCellEx plant cell based expression system.”