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.
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