Full Press Release Details
Reports Preliminary Data from its COVID-19 Compassionate Use Program, Treating Seven Patients with Acute Respiratory Failure
Israel, April 7, 2020 - Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI),
a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today preliminary
data from its compassionate use program, treating seven
patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem's
PLX cells, in three medical centers in Israel.
Patients' condition prior to the
treatment with PLX cells
approved for treatment under compassionate use program with PLX cells exhibited, prior to treatment, respiratory
failure due to ARDS, which is a major cause of mortality and required mechanical ventilation in an ICU. Four of the patients also
demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and poor
Preliminary data following treatment with PLX cells
Six of the seven patients have completed the seven day follow up period ("Group A"). The seventh patient has
not yet completed seven day follow up.
Pluristem's COVID-19 clinical development
As a next step, the Company plans to apply
for initiation of a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients
suffering from complications associated with COVID-19. In this regard, while Pluristem expects to continue treating patients for
complications associated with COVID-19 under the compassionate use program in Israel, Pluristem does not intend to provide further
updates on the status of this program and rather update on the status and progress of its contemplated clinical trial program.
"We are pleased with this initial outcome of the compassionate use program, and committed to harnessing PLX cells for the
benefit of patients and healthcare systems. In order to maximize PLX cells' impact on patient recovery and to work towards
making our treatment widely available, we plan to quickly move forward into a clinical development program. Pluristem is dedicated
to using its competitive advantages in large-scale manufacturing to potentially deliver PLX cells to a large number of patients
in significant need. We believe that research and governmental funding may be available to Pluristem to support the use of PLX
cells for patients suffering from COVID-19 and are targeting such funding," stated Pluristem CEO and President, Yaky Yanay.
PLX Cells for COVID-19
PLX cells are available off-the-shelf and
once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic.
PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system's
natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune
system. Accordingly, PLX cells may potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis
leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic
benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are
potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong
immunomodulatory potency of PLX cells in patients post major surgery. Taken together, PLX cells' potential capabilities
with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a
therapy for mitigating the tissue-damaging effects of COVID-19.
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 interim results from the use of PLX cells on
certain patients suffering from COVID-19, its expectation to continue treating patients for complications
associated with for COVID-19 under the compassionate use program in Israel and its intention not to provide further updates on
the status of this program and rather update on the status and progress of its contemplated clinical trial program, its
plans to apply for initiation of a multinational clinical trial in order to maximize PLX cells' impact on patient recovery
and to work towards making its treatment widely available, its dedication to using its competitive advantages in large-scale manufacturing
to potentially deliver PLX cells to a large number of patients in significant need, its belief that research and governmental
funding may be available to it to support its PLX cells for COVID-19 patients and its intent to target such funding, the potential
of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce
the fatal symptoms of COVID-19 induced pneumonia and pneumonitis, and PLX cells' position as a therapy for mitigating the
tissue-damaging effects of COVID-19. 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