pluristem therapeutics inc (PSTI) Key Developments
Pluristem Therapeutics Announces Publication of Scientific Study Regarding Placental eXpanded (PLX) Cells in Prominent Peer-Reviewed Journal Stem Cells
Jul 27 15
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.
Pluristem Therapeutics, Inc.'s PLX Cells Were Selected for European Medicines Agency's Adaptive Pathways Pilot Project
May 18 15
Pluristem Therapeutics, Inc. announced a significant advancement to its clinical development plan: the PLX cell program in critical limb ischemia has been selected for the European Medicines Agency'sAdaptive Pathways pilot project. The goal of the project is to improve timely access for patients to new medicines. It allows for early mar6Beting authorization of a therapy in a restricted patient population, followed by additional assessments and the possibility of later approval for use in broader patient populations. Critical limb ischemia (CLI), a severe blockage in the arteries of the legs which markedly reduces blood-flow, is associated with a significantly increased risk of leg amputation and death. It currently affects approximately one million people in the U.S., and the prevalence is expected to increase significantly in the coming decades. CLI therefore represents a major commercial opportunity. Acceptance of Pluristem's cells for the treatment of CLI into the Adaptive Pathways could significantly curtail the time and investment needed to bring this product to market.
Pluristem Therapeutics, Inc. Presents at Oppenheimer16th Annual Israeli Conference, May-10-2015
May 4 15
Pluristem Therapeutics, Inc. Presents at Oppenheimer16th Annual Israeli Conference, May-10-2015 . Venue: David Intercontinental Hotel, Tel-Aviv, Israel. Speakers: Zami Aberman, Executive Chairman and Chief Executive Officer.
Pluristem's Clinical Advisory Board Prepares Phase II Clinical Trials in Critical Limb Ischemia in Europe and Japan
Apr 20 15
Pluristem Therapeutics Inc. announced that its Clinical Advisory Board for Critical Limb Ischemia (CLI) concluded a key meeting in London, England. During the meeting, Clinical Advisory Board members, including Key Opinion Leaders in the treatment of CLI, outlined the Phase II study design and other critical components of advanced-stage trials for the Company's PLacental eXpanded (PLX) cells in the treatment of this peripheral artery disease. Pluristem has applied to conduct Phase II trials for CLI in regions with recently established rapid regulatory pathways, including the Accelerated Pathway for Regenerative Therapy in Japan and the Adaptive Pathway in the European Union. Two Phase I studies for CLI, previously completed in the U.S. and Germany, met all primary endpoints. Data from these trials suggested that the cells were safe and potentially efficacious at multiple dosage levels in this indication.
Pluristem Therapeutics, Inc., Annual General Meeting, May 26, 2015
Apr 2 15
Pluristem Therapeutics, Inc., Annual General Meeting, May 26, 2015., at 17:00 Israel Standard Time. Location: offices. Agenda: To elect nine directors to serve until the next annual meeting of stockholders and until their respective successors shall have been duly elected and qualified; to consider and approve by a nonbinding advisory vote, the compensation of its named executive officers; to ratify the selection of Kost Forer Gabbay & Kasierer, as independent registered public accounting firm of the company for the fiscal year ending June 30, 2015; and to consider and act upon such other business as may properly come before the meeting or any adjournment or postponement thereof.