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Pluristem Therapeutics

First product to enter market

Initiation | Pharmaceutical & healthcare | 23 Nov 2016

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

Grants and collaborations to support development

Update | Pharmaceutical & healthcare | 18 Oct 2017

Pluristem now has three ongoing clinical programs: critical limb ischemia (CLI, Phase III), intermittent claudication (IC, Phase II) and the acute radiation syndrome program (ARS, primates), which was recently expanded due to the participation of the US Department of Defense (DOD). Many of the costs of these programs have been offset, for instance due to NIH support of the ARS program as well as new grants of $16.6m to study PLX-PAD. The company recently received FDA and EMA sign-offs on a Phase III study in femoral neck fracture, which we expect to start shortly.

Pluristem Therapeutics

Positive trends in radiation treatment

Update | Pharmaceutical & healthcare | 20 Jun 2017

Pluristem reported data from its pilot study of PLX-R18 for the treatment of acute radiation syndrome (ARS). The study included 48 non-human primates (NHP) who were dosed with 4m, 10m, and 20m cells per kg and showed an improvement in survival to 83%, 86% and 67%, respectively, from 50% in the control arm, although the study was not powered to significance. The company will need to perform a pivotal primate study and a human safety study for approval, which we expect in 2019-20.

Pluristem Therapeutics

Ready for a big 2017

Update | Pharmaceutical & healthcare | 28 Feb 2017

2017 will be a significant year for Pluristem as the company expands its clinical program with a transnational Phase III clinical trial of PLX-PAD for critical limb ischemia (CLI). Pluristem recently put protocols in place in the US and Europe with plans to initiate in the first half of 2017. Additionally, it continues to make progress in its intermittent claudication (IC) Phase II clinical trial, which was fully enrolled as of January 2017, with data expected in early 2018.