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.
GaliaRahav, 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
