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United Therapeutics Receives Regulatory Approval To Commence Phase I Study Of Pluristem's PLX-PAD Cells For Pulmonary Arterial Hypertension

HAIFA, Israel, April 11, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, 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 (PET) scan.  

Zami Aberman, Chairman and Chief Executive Officer of Pluristem Therapeutics stated, "We are very pleased with the progress of the project, moving our partnership with United Therapeutics to the next step. The in-vitro and pre-clinical development studies demonstrated that the administration of PLX-PAD cells appears to be safe and potentially effective in animal models of PAH. We are now looking forward to receiving clinical data from this trial in evaluating the safety of our PLX-PAD cell in treating PAH patients."

Under the terms of Pluristem's licensing agreement with United Therapeutics Corporation, United Therapeutics made an upfront payment of $7 million to Pluristem. Pluristem is also eligible to receive regulatory milestone and other payments totaling up to an additional $48 million with United Therapeutics bearing all the costs of conducting all of the clinical trials for the indication of PAH. The licensing agreement also provides that, following commercialization, United Therapeutics will purchase the PLX-PAD cell product from Pluristem at a specified margin over Pluristem's cost. In addition, United Therapeutics will pay Pluristem specified royalties as a percentage of its gross profits generated from the sale of the PLX-PAD cell developed product.

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