Item 8.01. Other Events.
On June 11, 2020, Pluristem Therapeutics Inc., or the registrant, announced the
activation of clinical sites and initiation of enrollment in its Phase II U.S.
Food and Drug Administration (FDA) study of PLX cells for the treatment of
severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) and
that the trial is expected to include up to 25 sites. The registrant stated that
it is focused on expanding to clinical sites throughout the U.S. in accordance
with the changing dynamic spread of the COVID-19 pandemic, using its advanced
operational capabilities. The randomized, double-blind, placebo-controlled,
multicenter, parallel-group 140 patient study is evaluating the efficacy and
safety of intramuscular (IM) injections of PLX-PAD for the treatment of severe
COVID-19 cases complicated by ARDS. The primary endpoint is the number of
ventilator free days during the main 28-day study period. Safety and survival
follow-up will be conducted at week 8, 26 and 52. Secondary efficacy endpoints
include all-cause mortality, duration of mechanical ventilation, ICU free-days,
and hospitalization free-days.
Warning Concerning Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995 and federal securities laws. For example, forward-looking
statements are being used when the registrant discusses its focus on expanding
clinical sites throughout the U.S. and the expected number of clinical sites it
expects will be included in the trial. These forward-looking statements and
their implications are based on the current expectations of the management of
the registrant 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; the registrant may
encounter delays or obstacles in launching and/or successfully completing its
clinical trials; the registrant's products may not be approved by regulatory
agencies, the registrant's technology may not be validated as it progresses
further and its methods may not be accepted by the scientific community; the
registrant may be unable to retain or attract key employees whose knowledge is
essential to the development of our products; unforeseen scientific difficulties
may develop with our process; the registrant's products may wind up being more
expensive than the registrant anticipates; results in the laboratory may not
translate to equally good results in real surgical settings; results of
preclinical studies may not correlate with the results of human clinical trials;
the registrant's patents may not be sufficient; the registrant's products may
harm recipients; changes in legislation; 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 the registrant to differ materially from those
contemplated in such forward-looking statements. In addition, historic results
of scientific research do not guarantee that the conclusions of future research
would not suggest different conclusions or that historic results would not be
interpreted differently in light of additional research or otherwise. Except as
otherwise required by law, the registrant 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 the registrant, reference is made to the registrant's
reports filed from time to time with the Securities and Exchange Commission.
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