World Experts in Infectious Diseases & Critical Care Form Pluristem’s COVID-19 Steering Committee
October 20 2020 - 7:00AM
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, IsraelProfessor 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,
GermanyProfessor 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
TherapeuticsPluristem 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 StatementThis 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 RubinDirector of Investor
Relations972-74-7107194danar@pluristem.com
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