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Pluristem Therapeutics

Progress continues

Outlook | Pharmaceuticals & healthcare | 05 Feb 2018

Pluristem Therapeutics has had a productive FY18 to date. The company is advancing PLX-PAD in its Phase III study of critical limb ischemia (CLI) and Phase II study of intermittent claudication (IC), with the latter expecting results in early 2018. Additionally, the company received an orphan designation for PLX-R18 for acute radiation syndrome (ARS) currently in non-human primate studies and expanded its Phase I study for support of stem cell transplant to additional sites. We value Pluristem at $202m.

Pluristem Therapeutics

Termination of coverage

Termination | Pharmaceuticals & healthcare | 10 Jan 2019

Edison Investment Research is terminating coverage on Pluristem Therapeutics (PSTI). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

Pluristem Therapeutics

FY18 results and top-line claudication data

Update | Pharmaceuticals & healthcare | 07 Nov 2018

Pluristem ended FY18 with an operating loss of $33.7m mostly attributed to R&D expenditure ($22.6m) and as of 30 June 2018 had $30.6m in net cash. The company recently announced its plans to present at several November conferences, including top-line data from its Phase II intermittent claudication (IC) study at the American Heart Association (AHA) Scientific Sessions, as well as an overview of its cell therapy products in clinical development at BioEurope.

Pluristem Therapeutics

FDA gives two programs the green light with IND

Update | Pharmaceuticals & healthcare | 29 May 2018

In April 2018, Pluristem announced that the FDA had given two pipeline programs IND clearance: PLX-PAD for femoral neck fracture (FNF) healing and PLX-R18 for acute radiation syndrome (ARS). The company plans to initiate the Phase III trial investigating PLX-PAD for FNF healing later this year. IND approval of the PLX-R18 program allows for potential use of the product in the event of radiological emergencies for investigational purposes, which could provide in-human data.

Pluristem Therapeutics

New avenues of study

Update | Pharmaceuticals & healthcare | 28 Feb 2018

Pluristem continues to advance its PLX technology platform. In a recent paper it investigated the application of these cells for their ability to inhibit tumor growth; it was found that the cells inhibit growth of a mouse xenograft of a triple-negative breast cancer cell line and induced complete remissions in three out of 10 mice. Additionally, PLX-PAD received approval for an expanded access program from the FDA, allowing it to be used to treat critical limb ischemia (CLI) outside the ongoing Phase III clinical study.

Pluristem Therapeutics

Grants and collaborations to support development

Update | Pharmaceuticals & 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 | Pharmaceuticals & 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 | Pharmaceuticals & 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.

Pluristem Therapeutics

First product to enter market

Initiation | Pharmaceuticals & 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.