HAIFA, Israel, Sept. 8, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, announced today that its licensee, United Therapeutics Corporation, has completed the dosing of the first cohort of patients in its Phase I study using Pluristem’s PLacental eXpanded (PLX-PAD) cells in patients diagnosed with pulmonary arterial hypertension (PAH). PAH, with a global market estimated at approximately $3 billion, is characterized by abnormally high blood pressure in the arteries of the lungs; it can disrupt lung and heart function, leading to debilitating conditions such as heart failure.
The Phase I study, being conducted in Australia, is an open-label, dose-escalation study designed to enroll 9 patients diagnosed with PAH. The first cohort of 3 patients has received 0.5 million PLX cells per kilogram body weight. An independent Data Safety Monitoring Board recommended advancement to the second cohort. The second cohort will receive 1 million cells per kilogram, while the third cohort is planned to be administered 2 million cells per kilogram. The primary endpoint of the study is the safety of PLX-PAD cells, which will be evaluated at 12 weeks and one year after dosing. Secondary efficacy endpoints are to be measured at six weeks post-treatment in order to assess changes in the ability to exercise, disease severity and cardio-respiratory function; measures include six-minute walk distance and cardio-pulmonary hemodynamic parameters evaluated via right heart catheterization and echocardiogram.
“We look forward to preliminary results for this trial in 2015, after completion of dosing in all three cohorts,” stated Pluristem Chairman and CEO Zami Aberman. “This Phase I study is important to the development of our PAH program in conjunction with United Therapeutics, and we are delighted to work with United Therapeutics in advancing the promise of cell therapy to treat pulmonary diseases.”
The Phase I study is being conducted as part of a 2011 licensing agreement between United Therapeutics and Pluristem. Pursuant to the agreement, United Therapeutics will develop, market and sell Pluristem’s PLX-PAD cells for PAH. Pluristem is eligible to receive up to $55 million based on successful achievement of clinical milestones and commercialization, and reimbursement of certain R&D costs. Following commercialization, United Therapeutics will purchase commercial supplies of PLX-PAD cells from Pluristem at a specified margin over Pluristem’s cost, and will pay royalties at a percentage of its gross profits.
