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Pluristem (PSTI) Intermittent Claudication Study Enrolled


Pluristem Therapeutics Inc. PSTI announced that it has completed patient enrollment in a large multi-national phase II study on PLX-PAD cells for the treatment of intermittent claudication (IC), a subset of peripheral artery disease (PAD).

Shares of Pluristem have significantly outperformed the Zacks classified classified Medical-Biomedical and Genetics industry in the last one year with the stock surging 92.6% during this period, compared with the industry’s decline of 12.9%.

The study is being conducted to evaluate the safety and efficacy of PLX-PAD cells in comparison to placebo. While the primary efficacy endpoint is the change in maximal walking distance from baseline during an exercise treadmill test, secondary endpoints include hemodynamic and quality of life measurements.

Pluristem intends to report top-line data from the study in early 2018.

Early this week, Pluristem announced that the FDA has approved the company’s double-blinded, randomized, placebo-controlled phase III study (PACE) on PLX-PAD cells for the treatment of critical limb ischemia (CLI), another peripheral artery disease. Pluristem expects to begin enrolling patients in the study in both the U.S. and Europe during the first half of 2017.

Positive data would allow the company to file a regulatory application seeking approval for PLX-PAD in both the U.S. and the EU.

We are encouraged by the company’s progress with PLX-PAD. We note that the possibility of treating PADs like IC and CLI through intramuscular injections of PLX-PAD cells holds potential. Successful development could provide patients with an alternative treatment option to invasive procedures like angioplasty or vascular surgery, which may not even be an option for a considerable number of patients.

According to the press release issued by the company, IC affects as many as about 14 million patients in the U.S. alone.

Pluristem Therapeutics, Inc. Price and Consensus

Zacks Rank & Stocks to Consider

Pluristem currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in this industry include Anika Therapeutics, Inc. ANIK, Kite Pharma, Inc. KITE and Epizyme, Inc. EPZM. While Anika sports a Zacks Rank #1 (Strong Buy), Kite Pharma and Epizyme carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up approximately 33% in the past one year.

Kite Pharma’s loss estimates narrowed 2.1% and 0.2% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise twice in the four trailing quarters with an average beat of 7.89%.

Epizyme’s loss estimates narrowed 3% and 2.4% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise in each of the four trailing quarters, with an average beat of 14.03%. Its share price gained 8% in the past one year.

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