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Pluristem
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Pluristem To Present Initial Results From Its Phase I HCT Study With PLX-R18 Demonstrating Safety And Efficacy At ASH Annual Meeting
PLX-R18 demonstrated significant clinical improvements in Hb, ANC, and PLT among the high-dose cohort PLX-R18 was found to be safe and well-tolerated Topline results from
Benzinga · 5d ago
Pluristem to Present Initial Results from Its Phase I HCT Study with PLX-R18 Demonstrating Safety and Efficacy at the ASH Annual Meeting
* PLX-R18 demonstrated significant clinical improvements in Hb, ANC, and PLT among the high-dose cohort * PLX-R18 was found to be safe and well-tolerated * Topline results from the full Phase I clinical trial expected in Q1 2021 (n=21) HAIFA, Israel, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported the first clinical results for PLX-R18 in humans from its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The initial results consisted of the analysis of the first 19 patients enrolled, and not all patients completed a one year follow up.The initial data from the Phase I trial demonstrated: * The treatment with PLX-R18 was found to be safe and well-tolerated. * An overall improvement was observed in most patients, with the high-dose cohort showing clinically meaningful improvements from baseline to 9-month in hemoglobin (Hb); absolute neutrophil count (ANC) a measure of white blood cells; and platelet count (PLT). In this cohort, Hb levels increased from 9.29±0.5 to 13.19±1.2 (p=0.0019), ANC increased from 1.09±0.6 to 5.13±1.7 (p=0.018) and PLT increased from 45.7±10 to 175.9±28 (p=0.000012).Incomplete hematopoietic recovery poses a significant life-threatening condition to HCT recipients who fail to respond to standard of care treatments, making them vulnerable to infections and bleeding. PLX-R18 may address the unmet need in this patient population by stimulating the regenerative potential of bone marrow where other treatments have proven ineffective. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PLX-R18 in this indication.A presentation titled “Safety and Demonstrated Efficacy of Placenta-Derived Cell Therapy PLX-R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation: A Phase I International Multi-Center Study” will be held by Mr. Hillard M. Lazarus, MD, FACP, Professor of Medicine, Case Western Reserve University, and Member of the study's Steering Committee at the virtual 62nd ASH Annual Meeting and Exposition on December 5, 2020.Prof Hillard M. Lazarus commented on the results, “The use of Pluristem’s PLX-R18 product candidate in a group of patients who had extremely low blood counts resulted in actual clinical improvement with a significant rise in critical blood counts.”Pluristem CEO and President Yaky Yanay stated, “These first PLX-R18 data in humans support our expectations that our PLX platform can yield multiple regenerative therapeutics. This significant milestone adds to a pivotal year ahead with four readouts in Critical Limb Ischemia (CLI), muscle regeneration following hip fracture, COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS), and HCT evaluating both our PLX-PAD and PLX-R18 product candidates. We are committed to developing solutions for unmet medical needs based on our expertise attained over a decade and supported by our advanced platform technology and in-house manufacturing capabilities.”The ASH Annual Meeting is the world’s most comprehensive hematology event of the year featuring scientific abstracts highlighting updates on the most critical topics in hematology. With more than 18,000 members from nearly 100 countries, ASH is the world's largest professional society serving both clinicians and scientists around the world who are working to conquer blood diseases.About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses its Phase I HCT study, expected timing for reporting top line results from the full clinical study, its anticipation for a significant year with four readouts in CLI, muscle regeneration following hip fracture, COVID-19 complicated by ARDS, and HCT evaluating both our PLX-PAD and PLX-R18 product candidates, that these first PLX-R18 data in humans support its expectations that its PLX platform can yield multiple regenerative therapeutics or when it discusses developing solutions for unmet medical needs. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.Contact: Dana Rubin Director of Investor Relations 972-74-7107194 danar@pluristem.com
GlobeNewswire · 5d ago
Pluristem Therapeutics Inc.'s (NASDAQ:PSTI) Path To Profitability
Pluristem Therapeutics Inc. (NASDAQ:PSTI) is possibly approaching a major achievement in its business, so we would...
Simply Wall St. · 11/03 15:57
World Experts in Infectious Diseases & Critical Care Form Pluristems COVID-19 Steering Committee
HAIFA, Israel, Oct. 20, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today named medical experts to form the Steering Committee for its clinical program relating to Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Pluristem is currently conducting Phase II studies of its PLX-PAD cells to treat hospitalized patients suffering from severe COVID-19 complicated by ARDS in the U.S., Europe and Israel. The Company is also conducting an Expanded Access Program in the U.S. and a per-patient Compassionate Use Program in Israel. The Steering Committee announcement follows Pluristem’s recent expansion of its Phase II COVID-19 trial to Israel earlier this month. Comprised of five prominent professors and medical doctors in the fields of infectious diseases, critical care, pulmonology and internal medicine, Pluristem’s COVID-19 Steering Committee is chaired by Professor Dellinger, MD and includes:R. Phillip Dellinger, MD, MSc, MCCM, Cooper University Health Care, U.S. Professor Dellinger is a Professor of Medicine and Distinguished Scholar at Cooper Medical School of Rowan University (CMSRU) and Senior Critical Care Attending at Cooper University Hospital. Professor Dellinger is a past-President of the Society of Critical Care Medicine (SCCM) and was the 15th recipient of the SCCM Lifetime Achievement Award in 2015. He was the lead author of the 2004, 2008, and 2012 Surviving Sepsis Campaign International Guidelines on the Management of Severe Sepsis and Septic Shock and senior author on the 2016 guidelines. Galia Rahav, MD, PhD Sheba Medical Center, Israel Professor Rahav is the Head of the Infectious Diseases Unit and Laboratories at the Sheba Medical Center, and a full academic Professor of Internal Medicine and Infectious Diseases at the Sackler Faculty of Medicine, Tel Aviv University. Professor Rahav earned her MD from the Hebrew University Hadassah Medical School, Jerusalem and has specialization certificates in internal medicine, infectious diseases, and clinical microbiology.Mitchell Levy, MD, MCCM, FCCP, Brown University, U.S. Professor Levy is the Chief of the Division of Critical Care, Pulmonary, and Sleep Medicine, Department of Medicine, at The Warren Alpert Medical School of Brown University, where he also serves as a Professor of Medicine. He is also the Medical Director of the Medical Intensive Care Unit at Rhode Island Hospital, Providence, Rhode Island. Dr. Levy is a founding member and Executive Committee member of the Surviving Sepsis Campaign, a global initiative to improve the care of patients with severe sepsis. Professor Levy earned his MD from State University of New York at Buffalo. He is a past-President of the Society of Critical Care Medicine.Christian Putensen, MD, PhD, University Hospital Bonn, Germany Professor Putensen is a Professor of Intensive Care Medicine and Head of the Division of Intensive Care Medicine, Department of Anaesthesiology and Intensive Care Medicine, at the University Hospital Bonn. Professor Putensen is the past Executive Committee member and past chair of the Respiratory Section of the European Society of Intensive Care Medicine. Currently, he serves as Chairperson of the Intensive Care Medicine Scientific Subcommittee of the European Society of Anaesthesiology and Intensive Care Medicine. Professor Putensen’s research focus is pathophysiology and treatment of acute respiratory distress syndrome and sepsis.Tom van der Poll, MD, PhD, Amsterdam University Medical Centers, Netherlands   Professor van der Poll is the Professor of Medicine and Chair of the Department of Medicine at the Amsterdam University Medical Centers (Academic Medical Center - University of Amsterdam – and Free University Medical Center) in the Netherlands. He is board certified in internal medicine and infectious diseases. Professor van der Poll has made fundamental contributions to the understanding of the pathophysiology of sepsis.Professor Dellinger, Chair of Pluristem’s COVID-19 Steering Committee, commented, “With no approved treatments for ARDS due to COVID-19 available today, I am honored to chair Pluristem’s Steering Committee. I look forward to working with my esteemed colleagues to advise on the development of Pluristem’s COVID-19 treatment, which has the potential to help severe patients in need throughout the world.”“We’ve assembled this Steering Committee, comprised of prestigious leaders in their fields from around the world, to guide and help accelerate PLX-PAD’s clinical development path at this critical time. We highly value the knowledge, talent, and experience shared by each of these key opinion leaders as we join forces to deliver an effective cell therapy for the most severe cases of COVID-19,” stated Pluristem CEO and President, Yaky Yanay.About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the potential for Pluristem’s COVID-19 treatment to help severe patients in need throughout the world and that Pluristem and its COVID-19 steering committee will guide and help accelerate PLX-PAD’s clinical development and path. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.Contact:Dana Rubin Director of Investor Relations 972-74-7107194 danar@pluristem.com
GlobeNewswire · 10/20 12:00
Pluristem on go with cohort II of mid-stage chronic graft vs host disease study
Pluristem Therapeutics (PSTI) has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II.The study will evaluate PLX-PAD
Seekingalpha · 10/13 13:25
Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease Study
Reports internal efficacy and safety data from first cohortHAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center. GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient's body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3-month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells. Prof. Ram of Ichilov Hospital commented, “From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses."“Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication,” stated Pluristem CEO and President, Yaky Yanay.About cGvHD Chronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT). The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is ∼30% to 40% by National Institutes of Health criteria1. The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipient’s body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints. Long term immunosuppression is given to try to prevent or treat cGvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX-PAD cells may potentially treat chronic GvHD patients and mitigate symptoms. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.Contact:Dana Rubin Director of Investor Relations 972-74-7107194 danar@pluristem.com_________________________________ 1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/
GlobeNewswire · 10/13 12:00
Pluristem Announces Clearance To Move Forward With Enrollment For Cohort II In Investigator-Led Phase I/II Chronic Graft vs Host Disease Study
HAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today
Benzinga · 10/13 11:06
Pluristem Announced Approval to Expand its Phase II COVID-19 European Clinical Trial to Israel
Pluristem Therapeutics Inc. (Nasdaq: PSTI) announced today that it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company's COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany's regulatory agency.
Benzinga · 10/07 09:23
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The average PSTI stock price target is 16.10 with a high estimate of 25.00 and a low estimate of 12.00.
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Institutional Holdings
Institutions: 81
Institutional Holdings: 3.20M
% Owned: 12.47%
Shares Outstanding: 25.63M
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Key Executives
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Zalman Aberman
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Yaky Yanay
Chief Financial Officer/Treasurer/Secretary
Chen Franco-Yehuda
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Doron Shorrer
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Isaac Braun
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Mark Germain
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Moria Kwiat
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Issac Braun
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About PSTI
Pluristem Therapeutics Inc. is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The Company's lead indications are critical limb ischemia (CLI), recovery after surgery for femoral neck fracture and acute radiation syndrome. Its operations are focused on the research, development, clinical trials and manufacturing of cell therapeutics and related technologies. The Company's products include PLX-PAD and PLX R18. The Company's PLX cells are adherent stromal cells (ASCs) that are expanded using a three dimensional (3D) process. The system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. The Company's PLX products are administered using a standard needle and syringe. The Company's PLX products are in clinical-stage development for multiple indications, such as cardiovascular, orthopedic, pulmonary and women's health diseases.
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