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  • Pluristem Therapeutics, Inc. (PSTI) Licensee Gets Regulatory Approval To Begin Phase I Study Of PLX-PAD Cells 0 comments
    Apr 11, 2013 5:44 PM | about stocks: PSTI

    Pluristem Therapeutics is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ishemic diseases. The cells are grown using the company's proprietary 3D micro-environmental technology.

    The company today announced that following favorable pre-clinical studies, biotechnology firm United Therapeutics Corp. received approval to perform a human Phase 1 study in Australia using Pluristem's PLX-PAD cells in patients that have been diagnosed with pulmonary arterial hypertension (NYSE:PAH). This disease is characterized by abnormally high blood pressure in the arteries of the lungs and leads to a greater workload for the right side of the heart.

    United Therapeutics plans to conduct a single center, open-label, dose-escalation study in PAH patients. It plans to enroll up to 9 patients in three dosing levels with PLX-PAD cells administered intravenously. The main endpoint of the study is to evaluate the safety of PLX-PAD cells over the period of a year. There are also secondary efficacy endpoints at six week intervals.

    In 2011, Pluristem and United Therapeutics entered into a licensing agreement where United Therapeutics will develop, market, and sell Pluristem's PLX-PAD cells for PAH. Under terms of the agreement, United made an upfront payment of $7 million to Pluristem. Pluristem is also eligible to receive regulatory milestone and other payments that may total up to an additional $48 million. United bears all the costs of conducting the clinical trials.

    The licensing agreement also provides that, following commercialization, United Therapeutics will buy the PLX-PAD product at a specified margin over Pluristem's cost. In addition, United will pay Pluristem specified royalties as a percentage of its gross profits generated from the sale of the PLX-PAD cell products.

    For further information about Pluristem Therapeutics and its PLX-PAD products, visit pluristem.com

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net

    Stocks: PSTI
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