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Pluristem & United Therapeutics Progress with Phase I Study - Analyst Blog

Pluristem Therapeutics Inc . ( PSTI ) announced that its licensee, United Therapeutics Corporation ( UTHR ), completed dosing of the first of the three cohorts of patients in a phase I study.

Pluristem develops placenta-based cell therapies in collaboration with companies like United Therapeutics or through research and clinical institutions. The cells from the placenta, known as PLX cells, are derived using the company's proprietary PluriX therapy.

The open-label, dose-escalation phase I study is using Pluristem's PLacental eXpanded (PLX-PAD) cells in patients diagnosed with pulmonary arterial hypertension (PAH). The study is being conducted in Australia and will enroll nine patients.

Meanwhile, an independent Data Safety Monitoring Board recommended advancement to the second cohort.

The primary endpoint of the study is the safety of PLX-PAD cells. The safety of the cells will be evaluated at 12 weeks and one year after dosing. The preliminary results of the trial are expected in 2015 after dosing is complete in all three cohorts.

We note that United Therapeutics and Pluristem had entered into a licensing agreement in 2011 whereby United Therapeutics will develop, market and sell Pluristem's PLX-PAD cells for PAH. In exchange, Pluristem is entitled to receive up to $55 million of milestones payments along with the reimbursement of certain R&D costs. Upon 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.

We expect investor focus to remain on updates from the trial.

Meanwhile, Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene Corp. ( CELG ), is also researching stem cells derived from the human placenta as well as the umbilical cord for the treatment of different diseases.

Pluristem currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the broader health care sector might consider Gilead Sciences ( GILD ), carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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