Pluristem Therapeutics, Inc. (PSTI - Snapshot Report) recently announced that it will be initiating phase II studies that will evaluate the safety and efficacy of its placental expanded (PLX) cells in treating intermittent claudication (IC), a subset of peripheral artery disease (PAD). A study will be initiated in the US in the first week of September.
Notably, in April this year, the US Food and Drug Administration (FDA) had granted permission to Pluristem to initiate the IC phase II trial. The company already received approval from the Institutional Review Board (IRB) for its protocol. Trial protocol for 5 out of the 11 clinical sites in the US was approved by the IRB.
Pluristem plans to begin its site initiations with Duke University Medical Center on September 5 this year, which will be followed by other sites in the succeeding weeks. The company also plans site initiations in Europe and Israel besides the 11 sites in the US.
The phase II trial will be evaluating the safety and efficacy of two different doses of PLX-PAD cells in comparison with placebo. The study will consist of around 150 patients and the primary endpoint will be the change in maximum walking distance from baseline.
We note that earlier this month, Pluristem had extended its five-year old collaboration research agreement with the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charite - University Medicine Berlin. Pluristem and BCRT collaborated for several indications using the company’s patented PLX cells. The company targets a lucrative market worth up to $16.5 billion.
We currently have a Neutral recommendation on Pluristem. The stock carries a Zacks #3 Rank (Hold rating) in the short run.