Biotech Values

[dav1234]

PSTI Pluristem to Receive Clinical-hold Notice From the U.S. FDA

http://finance.yahoo.com/news/pluristem-receive-clinical-hold-notice-130000934.html

announced today 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

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