We are initiating coverage on Pluristem (NASDAQ:PSTI), a company developing allogenic cell therapies derived from donated placental tissue. The company has two products, PLX-PAD for the treatment of vascular disorders and PLX-R18 for hematologic disorders. The lead program is for critical limb ischemia (CLI), with a Phase III expected to start in 2017. Based on feedback from both the FDA and EMA, a single pivotal 250-patient study will be required for approval. Our valuation is $182m.
The appeal of placenta
Pluristem isolates mesenchymal stromal cells from placenta that are partially undifferentiated. The cells are not immortal or pluripotent like stem cells, reducing the risk of neoplasms, but they do secrete a large number of biologic molecules associated with growth and development. Additionally, they are inherently resistant to immune detection and can be used off the shelf without tissue typing.
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