Pluristem Provides Fiscal Year 2016 Corporate and Financial Highlights
September 12 2016 - 7:45AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading developer of placenta-based cell therapy
products, reported financial results and summarized corporate and
clinical developments for its fiscal year ended June 30, 2016.
“Over the past twelve months, Pluristem has made
major progress in executing its long-term strategy to target
accelerated regulatory pathways and shortening the time to market
for its products. These achievements position us to launch a series
of multinational pivotal phase III trials, targeting major markets
with significant unmet needs,” stated Pluristem Chairman and CEO
Zami Aberman.
“The potential of PLX cells has been
acknowledged by regulators and innovation programs from around the
globe. Our clinical development programs have been selected for
accelerated regulatory pathways to market, and we have been awarded
massive grants that enable us to move quickly and efficiently
towards pivotal studies.”
“We are now entering an exciting and very
meaningful stage for the company and are extremely confident in
Pluristem’s ability to execute on multiple fronts to bring the most
innovative and effective cell therapies to market,” concluded
Aberman.
Clinical and Corporate Highlights
Include:
- Multinational Phase III CLI Trials to
Commence
In the coming quarters, Pluristem plans to
commence enrolling an estimated 250 patients through clinical sites
in the U.S. and Europe for its Phase III trial of PLX-PAD cells in
the treatment of CLI, a $12 billion global market. The Company
intends to utilize this study as a single pivotal trial for
regulatory approval in both regions. The FDA has given Pluristem
positive feedback on the proposed Phase III trial. The EU has
accepted Pluristem’s PLX-PAD cells for the treatment of CLI in its
Adaptive Pathways pilot project, making PLX-PAD cells eligible for
conditional market clearance following one pivotal trial. The EU is
providing monetary support for the Phase III CLI trail through an
approximately $8 million grant from its Horizon 2020 program, which
will cover a significant portion of the trial costs.
In Japan, Pluristem intends to conduct a
75-patient pivotal trial for PLX-PAD in the treatment of CLI, via
Japan’s accelerated regulatory pathway for regenerative medicine.
Pluristem’s strategic plan is to partner with a Japanese partner to
conduct this study.
- Heading Towards Pivotal Trial for Market Approval in
the Treatment of ARS
The National Institute of Allergy and Infectious
Diseases (NIAID), a part of the U.S. NIH, is conducting dose
selection studies in large animals to determine optimal dosing for
Pluristem’s PLX-R18 as a medical counter measure in the treatment
of the hematologic components of Acute Radiation Syndrome (ARS).
Upon determining the optimal dose, a pivotal trial in large animals
is planned and the results will be used to support a Biologics
License Application (BLA) submission of PLX-R18 for this indication
under the Animal Rule regulatory pathway.
- FDA Clearance for Phase I Trial in Hematologic
Indication
In January 2016, the U.S. FDA cleared
Pluristem’s Investigational New Drug (IND) application to begin its
Phase I trial of PLX-R18 cells in the treatment of incomplete
hematopoietic recovery following Hematopoietic Cell Transplantation
(HCT).
- Phase III Hip Surgery Trial in
Preparation
Pluristem intends to conduct a Phase III trial
of PLX-PAD to evaluate its efficacy to improve recovery following
surgery for femoral neck fracture, which is the most common form of
hip fracture. Pluristem has already submitted the study protocol to
the EMA for a single pivotal trial in this indication through the
Adaptive Pathways Project and plans to meet with the FDA later this
year.
- Global Phase II IC Trial Nearing
Completion
The Company expects to complete enrollment of
all 170 patients in its global Phase II trial of PLX-PAD in the
treatment of Intermittent Claudication (IC) within the next couple
of months and to report trial results in 2017.
Financial Update:
As of June 30, 2016 Pluristem had approximately
$33 million in cash and cash equivalents, bank deposits, restricted
deposits and marketable securities. During the fiscal year,
Pluristem received a $3.3 million grant to support clinical trials
and R&D activities from the Israeli Innovation Authority of the
Israeli Ministry of Economy and Industry. The Company’s net cash
used for operating activities was $18.5 million during the fiscal
year. After the end of the fiscal year, in August 2016, Pluristem
was awarded a grant of approximately $8 million from the EU’s
Horizon 2020 program to fund its upcoming Phase III trial of
PLX-PAD in the treatment of CLI. Pluristem anticipates being well
capitalized to conduct the clinical trials planned for initiation
in the coming quarters, as well as ongoing R&D efforts to
support development of future products.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc., a late-stage
biotechnology company, is a leading developer of placenta-based
cell therapy products. The Company has reported robust clinical
trial data in multiple indications for its patented PLX (PLacental
eXpanded) cells. The cell products release a range of therapeutic
proteins in response to inflammation, ischemia, hematological
disorders, and radiation damage. PLX cell products are grown using
Pluristem’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring no tissue matching prior to
administration.
Pluristem has a strong intellectual property
position; Company-owned and operated, GMP-certified manufacturing
and research facilities; strategic relationships with major
research institutions; and a seasoned management team.
Safe Harbor Statement
This press release 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, we are using forward-looking
statements when we discuss the potential for our cell therapies
with respect to the treatment of peripheral artery disease and a
range of hematologic and orthopedic indications, the description,
timing and method of treatment and the proposed locations for our
proposed clinical trials, our expectations regarding the
possibility of accelerated regulatory approvals, our expected
timing and ability to bring our cell therapies to market, our plans
to partner with third parties to conduct studies and our
anticipation of being well capitalized to conduct the clinical
trials planned for initiation in the coming quarters as well
ongoing R&D efforts to support development of future products.
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; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our
products may not be approved by regulatory agencies, our technology
may not be validated as we progress further and our methods may not
be accepted by the scientific community; we 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; our products may wind up being more
expensive than we anticipate; 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; our patents may not be sufficient; our
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 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:
Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
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