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.
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