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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