Pluristem CEO, Zami Aberman Answers the Tough Questions

Pluristem CEO, Zami Aberman Answers the Tough Questions 
LOS ANGELES, CA -- (Marketwired) -- 06/06/13 --  Pluristem
Therapeutics Inc. (NASDAQ: PSTI) (TASE: PLTR), a leading developer of
placenta-based cell therapies, recently announced that it has
received notification from the U.S. Food and Drug Administration
(FDA) that its United States phase II Intermittent Claudication (IC)
study (IND 15038) has been placed on clinical hold due to a serious
allergic reaction in a case which required hospitalization. 
Out of 74 patients enrolled in Pluristem's trials to date, this is
the first case of a serious allergic event. This event occurred in a
patient with multiple diseases which may have influenced the severity
of the event. The patient was discharged from the hospital the
following day, following the resolution of all her symptoms. 
The FDA will issue a letter within the next 30 days detailing a list
of questions and requests for information from Pluristem. Zami
Aberman, Pluristem's Chairman and CEO, took time to answer questions
about the company.  
Q: What do you mean by the word "serious"? 
Aberman: According to the FDA a serious adverse event (SAE) in human
drug trials is defined as any untoward medical occurrence that, at
any dose, results in death, is life-threatening or requires inpatient
hospitalization.  
Q: So did the patient have anaphylactic shock? 
Aberman: The patient did not go into anaphylactic shock and her vital
signs were stable from the time she was first seen by medical
professionals and during her short hospitalization.  
Q: Does this mean that most likely you have to run an additional
safety study in US?  
Aberman: No, we will do the risk assessment based on the FDA's
questions, investigate what happened and continue the phase II study
once the FDA is satisfied with our responses. 
Q: What exactly is involved with a clinical hold? Does this affect
any of your other trials?  
Aberman: A clinical hold means that we will not recruit additional
patients into the US study until the FDA lifts the hold. This does
not affect the other trials, namely our muscle injury trial or
intermittent trial, both in Germany.  
What are the principal goals of the IC study (I have the
clinicaltrials.gov description) and what is the proposed timetable?  
Aberman: The principal goals of the IC Phase 2b, dose escalation
study is to evaluate the safety and efficacy of three different doses
of our PLacental Expanded (PLX) cells in the treatment of
Intermittent Claudication (IC), a subset of peripheral artery disease
(PAD). We anticipate that enrollment to the study will be completed
during H1/2014. 
Q: Any thoughts on how the clinical hold might affect that timetable? 
Aberman: We were notified by our regulator representative working
with the FDA about the clinical hold in the US due to a serious
allergic reaction. According the FDA guidelines, within 30 days we
will receive written notification that will include all the questions
and clarifications needed. We have enjoyed an excellent working
relationship with the FDA for several years and have received
valuable assistance on more than once occasion as we work together to
make cell therapy a reality. We will work continue to fully
cooperation with the FDA, as we have in the past, to resume the
clinical trial. We hope that in the upcoming weeks we will clarify
with the FDA all their issues in order to continue our trial in the
US as planned. Hopefully there will be a minimal, if at all,
influence on the trials' timetable. 
Q: Given the extensive exclusion criteria and the fact that the
company has not previously experienced a serious allergic event with
PLX, any thoughts as to what the company will examine first in this
case?  
Aberman: The patient suffered from serious background diseases and
was chronically oxygen dependent. Approximately 12 hours following
the intramuscular treatment with our PLX cells, the patient noted a
rash and experienced shortness of breath. She was treated in the
hospital and released approximately 12 hours after admission
following the resolution of all her symptoms. We are investigating to
see if there are connections between her reaction and our treatment.  
Q: Also, what is the immediate impact, if any, of the clinical hold
on the company's other development activities?  
Aberman: The only trial effected by the hold is the PLX-PAD phase II
Intermittent Claudication (IC) study and the CLI study in the U.S.
There is no impact on the PLX-PAD other clinical trials outside the
US underway or planned at this time.  
Q: Finally, is there any additional information/background that would
help our readers understand the PLX technology, the IC study or the
effect of the clinical hold? 
Aberman: Pluristem's PLX cells are mesenchymal-like adherent stromal
cells (ASCs) derived from full term human placentas. These cells are
expanded in the company's proprietary bioreactor system that creates
a three-dimensional (3D) microenvironment. This 3D technology allows
for the controlled, large-scale growth of cells implementing an
optimized, standardized, scaled-up and "hands-off" operation. This
allows PLX cells to be mass-produced with batch-to-batch consistency
in an effective and controllable process. Furthermore, Pluristem's 3D
expansion technology allows for the production of specific PLX cell
products for each of the Company's targeted indications.  
Healthcare investors and Biotech traders interested in accessing
BioMedReports' new complete database of clinical trials and upcoming
FDA and world-wide regulatory decisions which can be used to make
more profitable trades and see upcoming catalysts can go to:
http://biomedreports.com/fdacal.html 
Follow Us 
News developments and live healthcare sector updates are available
constantly via twitter at: http://twitter.com/BioMedReports 
About BioMedReports.Com 
BioMedReports is a news and research portal covering financial
biotech news for the entire Healthcare Sector of the market.
BioMedReports is not paid or compensated to report the news and
developments of publicly traded companies. BioMedReports sells a
premium product for subscribers and full disclosures and information
about the stocks and news mentioned in this news release are
available at BioMedReports.Com 
Media Contacts Only:
M. Davila 
Assistant Editor
BioMedReports.Com 
e-mail: info@biomedreports.com 
 
 
Press spacebar to pause and continue. Press esc to stop.