Pluristem Therapeutics, Inc. (PSTI) Licensee Gets Regulatory Approval to Begin Phase I Study of PLX-PAD Cells

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 (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 www.pluristem.com

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