United Therapeutics Receives Regulatory Approval to Commence Phase I Study of Pluristem's PLX-PAD Cells for Pulmonary Arterial Hypertension
Pluristem Therapeutics (NASDSQ: PSTI) announced today that following favorable preclinical studies, United Therapeutics Corporation received approval to perform a human Phase I study in Australia using Pluristem's PLacental eXpanded (PLX-PAD) cells in patients diagnosed with Pulmonary Arterial Hypertension (PAH). On June 20, 2011 United Therapeutics and Pluristem entered into a licensing agreement pursuant to which United Therapeutics will develop, market and sell Pluristem's PLX-PAD cells for PAH.
PAH is characterized by abnormally high blood pressure in the arteries of the lungs and leads to an increased workload on the right side of the heart.
United Therapeutics plans to conduct a single center, open-label, dose-escalation study in patients diagnosed with PAH. The study will enroll up to nine patients in three dosing levels with PLX-PAD cells administered intravenously (IV). The primary endpoint of the study is to evaluate the safety of PLX-PAD cells in a follow-up period of one year. Secondary efficacy endpoints at six weeks post-treatment are designed to assess cardio-respiratory function and include six-minute walk distance, cardiac hemodynamic parameters via a right heart catheterization and echocardiogram and pulmonary metabolism via a positron emission tomography