Pluristem Comments on Article Published on Bloomberg
HAIFA, Israel, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell
therapies, offered comments on an article published in Bloomberg on November
7, 2012.Pluristem has submitted a direct request to Bloomberg to publish a
correction because the article it published is factually inaccurate and
The subject of the article was a pediatric patient who was critically ill, in
imminent danger of death and who had exhausted all other treatments.The
patient was treated on a compassionate use basis in Israel, and was not part
of Pluristem's ongoing clinical program.The patient was able to leave the
hospital and survived six months, the last four of them in her home country of
Romania.Pluristem was not monitoring the patient and learned of her death at
the discretion of her family and physician.In addition, the formal report
relating to the death clearly stated that there was no connection between the
PLX cell treatment and the death of the patient.
Pluristem has requested Bloomberg issue a correction specific to the article's
claim and implication that Pluristem knew of the death of this patient at the
time of a recent capital raising transaction and withheld this information
from its investors. This is not correct. The Company did not learn of this
fact until after the financing was completed.
Pluristem wishes to emphasize that compassionate use cases are entirely
experimental and last resort efforts in desperate situations and obviously not
predictive of ultimate success or failure.Further, adverse results from
causes unrelated to the subject therapy are also irrelevant in the evaluation
of that therapy.
In situations where Pluristem conducts clinical trials, it follows disclosure
standards consistent with industry practice and applicable law, based on data
made available to it after appropriate analysis. In response to the publicity
surrounding this event, Pluristem wishes to make it clear that three patients
were given compassionate use treatment with Pluristem's PLX cells.All three
had failed all other treatment and were at risk of imminent death.The
pediatric patient referred to in the Bloomberg article survived for six
months, another patient survived for four months, and the third is still
alive. Pluristem believes that these results exceeded longevity expectations.
The unfortunate deaths of the patients do not diminish these results.
About Pluristem Therapeutics Inc.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer
of placenta-based cell therapies. The Company's patented PLX (PLacental
eXpanded) cells are a drug delivery platform that releases a cocktail of
therapeutic proteins in response to a host of local and systemic inflammatory
and ischemic diseases. PLX cells are grown using the company's proprietary 3D
micro-environmental technology and are an "off-the-shelf" product that
requires no tissue matching prior to administration. Pluristem is focusing on
the use of PLX cells administered locally to treat systemic diseases and
potentially obviating the need to use the intravenous route.
Data from two phase I studies indicate that Pluristem's first PLX product
candidate, PLX-PAD, is safe and potentially effective for the treatment of end
stage peripheral artery disease when given locally. Additionally, Pluristem is
developing PLX-PAD for cardiac ischemia, PLX-BMP for Acute Radiation Exposure,
Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia,
PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in
collaboration with United Therapeutics. Pluristem's pre-clinical animal models
have demonstrated PLX cells are also potentially effective in other
inflammatory and ischemic indications, including diastolic heart failure,
inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.
Pluristem has a strong patent portfolio, GMP certified manufacturing and
research facilities as well as strategic relationships with major research
For more information visit www.pluristem.com and follow Pluristem on Twitter
@Pluristem, the content of which is not part of this press release.
The Pluristem Therapeutics Inc. logo is available at
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 our belief that the compassionate treatments
results exceeded longevity expectations and that the unfortunate deaths of
patients does not diminish these results, when we say that data from two Phase
I clinical trials indicate that Pluristem's first PLX product, PLX-PAD, is
safe and potentially effective for the treatment of end stage PAD or when we
say that Pluristem's pre-clinical animal models have demonstrated PLX cells
are also potentially effective in other inflammatory/ischemic indications.
These forward-looking statements 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 our clinical
trials; 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 surgical settings; 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.
William Prather R.Ph., M.D.
Sr. VP Corporate Development
Director Investor & Media Relations
Pluristem Therapeutics Inc. Logo
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