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Last $1.98 USD
Change Today +0.03 / 1.54%
Volume 63.1K
PSTI On Other Exchanges
Tel Aviv
As of 8:10 PM 08/28/15 All times are local (Market data is delayed by at least 15 minutes).

pluristem therapeutics inc (PSTI) Snapshot

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pluristem therapeutics inc (PSTI) Details

Pluristem Therapeutics Inc., through its subsidiary, Pluristem Ltd., operates as a bio-therapeutics company in Israel. The company focuses on the research, development, clinical trial, and manufacture of cell therapeutics products and related technologies for the treatment of various ischemic and inflammatory conditions. Its patented PLacental eXpanded (PLX) cells function as a platform that releases a number of therapeutic proteins in response to various local and systemic inflammatory and ischemic signals generated by the patient. The company’s PLX cells are grown using proprietary 3D micro-environment technology that produces an off-the-shelf allogeneic cell therapy products. It also develops PLX-PAD cells, which are in Phase-II clinical trial for use in the treatment of peripheral and cardiovascular, orthopedic, and pulmonary diseases, as well as for hematological and women’s health diseases; and PLX-RAD cells used for acute radiation syndrome treatment of animals, as well as products in pre-clinical trial for the treatment of pre-eclampsia and rotator-cuff repair. The company is also involved in the development and commercialization of a PLX cell-based product for the treatment of pulmonary arterial hypertension through its license agreement with the United Therapeutics Corporation; and commercialization agreement with CHA Bio&Diostech for conducting clinical trials and commercialization of PLX-PAD products in South Korea. Pluristem Therapeutics Inc. was founded in 2001 and is based in Haifa, Israel.

160 Employees
Last Reported Date: 09/11/14
Founded in 2001

pluristem therapeutics inc (PSTI) Top Compensated Officers

Executive Chairman and Chief Executive Office...
Total Annual Compensation: $503.7K
President, Chief Operating Officer and Direct...
Total Annual Compensation: $270.0K
Compensation as of Fiscal Year 2014.

pluristem therapeutics inc (PSTI) Key Developments

Pluristem Therapeutics Inc. Announces Japan's Pharmaceuticals and Medical Devices Agency Clears its PLX-PAD Cells for Use in Clinical Trials in Japan

Pluristem Therapeutics Inc. announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Company's PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan's accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time-limited marketing approval after a single successful Phase II trial. Safety clearance is the second of three authorizations required by the PMDA prior to commencement of a Phase II trial. Pluristem announced that it received the first of these in May 2015, when the Agency accepted PLX-PAD cells' quality standards and large-scale manufacturing methods. The third and final step, yet to be achieved, is approval of the clinical study design.

Pluristem Therapeutics Inc. Conducts Discussions with the European Adaptive Pathways Discussion Group Regarding the Clinical Development Plan for PLX Cells in Critical Limb Ischemia Patients

Pluristem Therapeutics Inc. announced that it has conducted detailed discussions with the European Adaptive Pathways Discussion Group regarding the clinical development plan for PLX cells in Critical Limb Ischemia (CLI) patients, and received guidance on the planned design of the initial Phase II trial of PLX cells in a subgroup of patients with severe CLI. Positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication. Pluristem is receiving this in-depth guidance from European regulatory officials following the selection of this clinical program for the European Medicine Agency's Adaptive Pathways project in May 2015. In the discussions the company also presented other indications for potential development through the Adaptive Pathways project; these were ischemic stroke, muscle wasting, hip fracture and additional subgroups of CLI. The Adaptive Pathways project is part of the European Medicine Agency's (EMA) efforts to improve timely access for patients to new therapies. It targets treatments with the potential to heal serious conditions with an unmet medical need, and may reduce the time to a medicine's approval or to its reimbursement for targeted patient groups.

Pluristem Therapeutics Announces Publication of Scientific Study Regarding Placental eXpanded (PLX) Cells in Prominent Peer-Reviewed Journal Stem Cells

Pluristem Therapeutics Inc. announced the publication of a scientific study regarding PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Stem Cells. The paper, titled "Mesenchymal stromal cells prevent allostimulation in vivo and control checkpoints of Th1 priming: migration of human DC to lymph nodes and NK cell activation", describes the findings of a recent mechanism of action study conducted by independent scientists at the Berlin-Brandenburg Center for Regenerative Therapy at Charité - University Medicine Berlin. The paper was co-authored by scientists from the Charité and Pluristem. The study demonstrated mechanisms by which PLX cells and other mesenchymal stromal cells (MSC) influence the immune system in order to modulate immune reactions and to prevent immune reactions against the cells when they are administered as an off-the-shelf product (unmatched). It was demonstrated in vitro that MSC, and in particular PLX cells, control the induction of an immune response at several points. The main target for MSC and PLX cells in this process are dendritic cells, which are the key player in inducing a T-cell immune response. Moreover, in vivo data from patients suffering from critical limb ischemia who were treated with PLX cells in a phase I/II study confirmed that HLA-unmatched PLX cells did not provoke an immune response in immunocompetent patients. These findings confirm the feasibility of using PLX cells in an off-the-shelf manner, and explain the mechanisms that make this possible.


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