Full Press Release Details
Reports Topline Results from its Phase II Studies of
Acute Respiratory Distress Syndrome Associated
Israel, Dec 27, 2021 - Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company,
today announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections
of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The analysis is based on 89
patients enrolled in two Phase II studies in the U.S. (the "U.S. study") and in Europe and Israel (collectively, the "EU
study" and together with the U.S. study, the "Studies").
primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. VFD at day 60 and all-cause
mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. The Studies did not meet the primary efficacy
endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS
patients, no differences in the safety profile were observed between PLX-PAD and placebo.
July 2021, Pluristem announced its decision to bring the Studies to early clinical readout based on 89 patients enrolled, instead of
the originally planned 180 patients (140 in the U.S. study and 40 in the EU study). The decision came in response to COVID-19's
evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of
the intubated patients. These changes in the evolution of COVID-19 raised a major concern about the potential variability in the patient
population in the Studies. The early termination of recruitment led to a significant reduction in the statistical power of the Studies.
trends from the Studies included:
CEO and President, Yaky Yanay said: "Pluristem joined the global effort to fight the evolving and unexpected COVID-19 pandemic.
We chose to focus on the most severe intubated patients suffering from ARDS associated with COVID-19, that have no viable treatment to
date and are challenging healthcare systems worldwide. With the new coming wave of the Omicron variant, we intend to explore the opportunities
based on the efficacy trends obtained from the Studies. I would like to thank everyone who has been involved in the Studies including
the patients and their families, our investigators and study personnel, and the team at Pluristem for making extraordinary efforts to
conduct these important studies during very challenging times."
U.S. Study included 66 patients enrolled to a randomized, double-blind, placebo-controlled, multicenter, parallel-group study, with three
treatment groups of PLX-PAD cells - single administration of 300 million cells, single administration of 600 million cells, or 300 million
cells administered twice in a one-week interval; and two placebo control groups single administration, and two administrations in a one-week
interval. All groups received a study treatment in addition to the best standard medical care according to local practices.
EU Study enrolled 23 patients in Germany, Bulgaria, and Israel to a randomized, controlled, multicenter, parallel-group study with a
single treatment group (single dose of 300 million PLX-PAD cells) in addition to best standard medical care according to local practices,
and a control group received the best standard medical care according to local practices.
is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company's
cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle,
hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent
source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can potentially treat more than
20,000 patients. The Company's manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed
to mimic the human body. Pluristem's method is uniquely accurate, cost-effective, and consistent batch-to-batch.
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 intention to explore
opportunities based on the data obtained from the Studies. 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.
Director of Investor Relations