First product to enter market
We are initiating coverage on Pluristem Therapeutics, 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.Pluristem Therapeutics is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The company's product candidates include: PLX-PAD, which is in a multinational clinical trial in critical limb ischemia, and in a multinational clinical trial in recovery following surgery for hip fracture; PLX-R18, which is under development in the U.S. for acute radiation syndrome, as well as in a trial in the U.S. and Israel for incomplete hematopoietic recovery following hematopoietic cell transplantation; and PLX-Immune, which is under pre-clinical development for treatment of certain human cancer types.
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